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Background Individuals with diabetes have a high frailty burden and increased risk of heart failure (HF). In this study, we evaluated the association of baseline and longitudinal changes in frailty with risk of HF and its subtypes: HF with preserved ejection fraction (HFpEF), and HF with reduced ejection fraction (HFrEF). Methods Participants (age: 45–76 years) of the Look AHEAD trial without prevalent HF were included. The frailty index (FI) was used to assess frailty burden using a 35-variable deficit model. The association between baseline and longitudinal changes (1- and 4-year follow-up) in FI with risk of overall HF, HFpEF (ejection fraction [EF] ≥ 50%), and HFrEF (EF < 50%) independent of other risk factors and cardiorespiratory fitness was assessed using adjusted Cox models. Results The study included 5 100 participants with type 2 diabetes mellitus, of which 257 developed HF. In adjusted analysis, higher frailty burden was significantly associated with a greater risk of overall HF. Among HF subtypes, higher baseline FI was significantly associated with risk of HFpEF (hazard ratio [HR] [95% CI] per 1-SD higher FI: 1.37 [1.15–1.63]) but not HFrEF (HR [95% CI]: 1.19 [0.96–1.46]) after adjustment for potential confounders, including traditional HF risk factors. Among participants with repeat measures of FI at 1- and 4-year follow-up, an increase in frailty burden was associated with a higher risk of HFpEF (HR [95% CI] per 1-SD increase in FI at 4 years: 1.78 [1.35–2.34]) but not HFrEF after adjustment for other confounders. Conclusions Among individuals with type 2 diabetes mellitus, higher baseline frailty and worsening frailty burden over time were independently associated with higher risk of HF, particularly HFpEF after adjustment for other confounders.

Objective Recovery from weight regain is uncommon during weight loss treatment. This study examined whether participants in a weight gain prevention intervention similarly struggle to recover following weight gains and which factors predict transitions. Methods This is a secondary analysis of data from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized controlled trial comparing two weight gain prevention interventions with a control group. Young adults (n = 599; age 18-35 years) were followed over 3 years. Markov models identified transition rates in going above and returning below baseline weight across follow-up. Logistic regressions identified predictors of transitions. Results At each time point, approximately double the number of participants who transitioned from below to above baseline transitioned from above to below. The magnitude of weight changes from baseline and the number of weight loss strategies used predicted transitions from below to above and above to below baseline weight (with opposite relationships). Infrequent self-weighing and lower dietary restraint predicted transitions below to above baseline weight. Treatment arm, demographics, calorie consumption, and physical activity generally did not predict transitions. Conclusions Young adults engaging in weight gain prevention struggle to lose gained weight. Alternative strategies are needed to address weight gains in weight gain prevention interventions.

To assess associations that endogenous estradiol and testosterone levels have with cognitive function in older adults with Type 2 diabetes mellitus (T2DM).We use data from the Look AHEAD clinical trial of behavioral weight loss. Endogenous estradiol and total testosterone levels were determined using stored serum from 996 individuals, mean age 69 years, at two times (averaging 4 years apart) during years 8-18 of follow-up. One to four standardized assessments of attention, executive function, memory, and verbal fluency were collected during this follow-up. Mixed effects models and multiple imputation were used to assess associations that estradiol and total testosterone levels had with body mass index and cognitive function.Estradiol levels were not associated with cognitive function in either sex. Total testosterone levels were not associated with cognitive function in women, but greater total testosterone levels were associated with better verbal fluency in men (p 0.001), most strongly among those carrying the APOE-e4 allele (interaction p = 0.02). The weight loss intervention left a legacy of relatively lower cognitive functioning among women, which was not mediated by current levels of sex hormones.Behavioral weight loss intervention does not affect cognitive functioning through mechanisms related to estradiol or testosterone.gov Identifier: NCT00017953.

Evidence has established obesity as a risk factor for total knee replacement (TKR) due to osteoarthritis. Obesity is a risk factor for TKR. Randomized trials such as Look AHEAD (Action for Health in Diabetes) have shown long-term successful weight loss with an intensive lifestyle intervention (ILI). It is unknown, however, if intentional weight loss can reduce the risk of TKR.Look AHEAD randomized persons aged 45-76 with type 2 diabetes who had overweight or obesity to either an ILI to achieve/maintain 7% weight loss or to standard diabetes support and education (DSE). Reported knee pain was assessed using the Visual Analog Scale and Western Ontario McMaster University Osteoarthritis Index questionnaire in 5125 participants without previous TKR. Cox proportional hazard regression was used to model differences in risk of TKR in relation to randomization group assignment (ILI vs DSE) along with baseline body mass index category and baseline knee pain as potential confounders from baseline through Look AHEAD-Extension.Baseline mean ± SD Western Ontario McMaster University Osteoarthritis Index knee pain scores did not differ by treatment assignment (ILI: 3.6 ± 2.9, DSE: 3.9 ± 3.0, P = .08); as expected due to randomization. During follow up, the 631 (12%) participants who reported having a TKR were more likely to have been heavier (P.001) and older (P.001) at enrollment, but risk of TKR did not differ by treatment group assignment (hazard ratio [HR] 1.07, 95% confidence interval [CI] 0.91-1.25, P = .43). Heterogeneity of treatment effect was observed according to baseline knee pain (interaction P = .02). In persons without knee pain at baseline, there was a 29% reduced risk of TKR in ILI compared to DSE (HR 0.71, 95% CI 0.52-0.96). However, in persons with knee pain at baseline, there was no statistically significant association of treatment assignment with respect to subsequent TKR incidence (HR 1.11, 95% CI 0.92-1.33).Findings suggest that intensive lifestyle change including physical activity, dietary restriction and behavioral changes to achieve weight loss for prevention of TKR may be most effective in preventing TKR prior to the development of knee pain.

Objective This study aimed to characterize young adults who experienced significant weight gains (> 10%) over 3 years in a weight gain prevention program. Methods Secondary data analysis from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized trial comparing two self-regulation interventions and a control arm in young adults (18-35 years; BMI 21-30.9 kg/m2 ), was used. Large Gainers (≥ 10% of their body weight; n = 48), Small Gainers (2.6%-9.9%; n = 149), and Weight Stable participants (± 2.5%; n = 143) were compared on dimensions affecting weight gain. Results Differences in weight gain among the three groups were significant by year 1 and subsequently increased. Those who became Large Gainers were heavier at baseline and further below their highest weight, and they reported more weight cycling than Weight Stable, with Small Gainers intermediate. Neither study arm nor pregnancy explained weight change differences among the three groups. Large Gainers reported more depressive symptoms than Weight Stable at years 1 and 2. Large Gainers were less likely to weigh themselves at least weekly at 4 months, before differences in weight gain emerged, and at years 1 and 2. Conclusions Large Gainers (representing almost 10% of participants) could be identified early by greater weight issues at baseline and lower use of weight gain prevention strategies.

OBJECTIVE The study objective was to determine whether two self-regulation interventions that reduced 3-year weight gain in young adults remain effective at 6 years. METHODS A randomized trial was conducted in two academic settings in 599 young adults, aged 18 to 35 years, with normal weight or overweight; 504 (84%) reconsented for a 6-year extension (Study of Novel Approaches to Weight Gain Prevention-Extended [SNAP-E]) with ongoing intervention and assessments. Weight gain over 6 years was compared for all assigned to Control, Large Changes (LC; lose 5-10 pounds initially), and Small Changes (SC; make small daily changes in intake and activity). RESULTS Weight change from baseline to 6 years did not differ significantly among the three groups (Control = 3.9 kg, SC = 4.1 kg, and LC = 2.8 kg). However, there was a significant age-by-treatment interaction (P = 0.002). Among those

Background Indices of multimorbidity and deficit accumulation (ie, frailty indices) have been proposed as markers of biological aging. If true, changes in these indices over time should predict downstream changes in cognition and physical function, and mortality. Methods We examined associations that 8-year changes in (i) a multimorbidity index comprised of 9 chronic diseases and (ii) a frailty index (FI) based on deficit accumulation in functional, behavioral, and clinical characteristics had with subsequent measures of cognitive and physical function over 10 years. We drew data from 3 842 participants in the Action for Health in Diabetes clinical trial. They were aged 45–76 years at baseline and at risk for accelerated biological aging due to overweight/obesity and type 2 diabetes mellitus. Results A total of 1 501 (39%) of the cohort had 8-year increases of 1 among the 9 diseases tracked in the multimorbidity index and 868 (23%) had increases of ≥2. Those with greatest increases in multimorbidity tended to be older individuals, males, and non-Hispanic Whites. Greater FI increases tended to occur among individuals who were older, non-Hispanic White, heavier, and who had more baseline morbidities. Changes in multimorbidity and FI were moderately correlated (r = 0.26; p < .001). Increases in both multimorbidity and FI were associated with subsequently poorer composite cognitive function and 400-m walk speed and increased risk for death (all p < .001). Conclusions Accelerated biological aging, as captured by multimorbidity and frailty indices, predicts subsequent reduced function and mortality. Whether intensive lifestyle interventions generally targeting multimorbidity and FI reduce risks for downstream outcomes remains to be seen. Clinical Trials Registration Number: NCT00017953

Objective Despite weight loss challenges in young adulthood, 17% of participants in the Study of Novel Approaches to Weight Gain Prevention (SNAP) weight gain prevention study lost ≥ 5% of their body weight at 3 years. These "weight losers" (n = 88) were compared to "weight maintainers" (n = 143), who successfully prevented weight gains by staying within ± 2.5% of their baseline weight at 3 years. Method Weight losers and maintainers (n = 231; 18-35 years old) were drawn from the SNAP randomized controlled trial (n = 599), which compared two weight gain prevention interventions with a control group. Participants completed anthropometric and psychosocial assessments at baseline, 4 months (end of face-to-face intervention), and 1, 2, and 3 years. Results Three-year weight losers had significantly greater weight losses than maintainers by 4 months, and weight trajectories continued to diverge. Three-year weight change group was not associated with treatment assignment. At pretreatment, weight losers were heavier, closer to their self-reported highest ever weight, and further away from their self-identified ideal weight. Across treatment, weight losers had greater dietary restraint and autonomous motivation, had lower disinhibition and self-identified ideal weight, and self-weighed more frequently than weight maintainers. Conclusions Weight gain prevention messaging may be sufficient to initiate weight loss in a subset of young adults who are heavier and closer to their highest weight at baseline. Psychological and behavioral characteristics more consistent with weight loss may explain differences in weight outcomes between losers and maintainers at 3 years. Future studies may consider the effects of weight gain prevention versus weight loss messaging in tailoring weight control interventions for young adults. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

OBJECTIVE: This study examined end-of-trial health outcomes in participants in the Look AHEAD (Action for Health in Diabetes) trial who had bariatric surgery during the approximately 10-year randomized intervention. METHODS: Data were obtained from the Look AHEAD public access database of 4901 individuals with type 2 diabetes and overweight/obesity who were assigned to intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) control group. Changes in outcomes in participants who had bariatric surgery were compared with those in participants with a body mass index (BMI) ≥ 30 kg/m(2) who remained in the ILI and DSE groups. RESULTS: A total of 99 DSE and 97 ILI participants had bariatric surgery. At randomization, these 196 participants were significantly younger and more likely to be female and to have higher BMIs than the remaining ILI (N=1972) and DSE (N=2009) participants. At trial’s end, surgically-treated participants lost 19.3% of baseline weight, compared with 5.6% and 3.3% for the ILI and DSE groups, respectively, and were more likely to achieve partial or full remission of their diabetes. CONCLUSIONS: The large, sustained improvements in weight and diabetes observed in this self-selected sample of surgically-treated participants are consistent with results of multiple randomized trials.

There is marked heterogeneity in the response to weight loss interventions with regards to weight loss amount and metabolic improvement. We sought to identify biomarkers predictive of type 2 diabetes remission and amount of weight loss in individuals with severe obesity enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) and the Look AHEAD (Action for Health in Diabetes) studies. Targeted mass spectrometry-based profiling of 135 metabolites was performed in pre-intervention blood samples using a nested design for diabetes remission over five years (n = 93 LABS, n = 80 Look AHEAD; n = 87 remitters), and for extremes of weight loss at five years (n = 151 LABS; n = 75 with high weight loss). Principal components analysis (PCA) was used for dimensionality reduction, with PCA-derived metabolite factors tested for association with both diabetes remission and weight loss. Metabolic markers were tested for incremental improvement to clinical models, including the DiaRem score. Two metabolite factors were associated with diabetes remission: one primarily composed of branched chain amino acids (BCAA) and tyrosine (odds ratio (95% confidence interval) [OR (95% CI)] = 1.4 [1.0–1.9], p = 0.045), and one with betaine and choline (OR [95% CI] = 0.7 [0.5–0.9], p = 0.02).These results were not significant after adjustment for multiple tests. Inclusion of these two factors in clinical models yielded modest improvements in model fit and performance: in a constructed clinical model, the C-statistic improved from 0.87 to 0.90 (p = 0.02), while the net reclassification index showed improvement in prediction compared to the DiaRem score (NRI = 0.26, p = 0.0013). No metabolite factors associated with weight loss at five years. Baseline levels of metabolites in the BCAA and trimethylamine-N-oxide (TMAO)-microbiome-related pathways are independently and incrementally associated with sustained diabetes remission after weight loss interventions in individuals with severe obesity. These metabolites could serve as clinically useful biomarkers to identify individuals who will benefit the most from weight loss interventions.

Objective This study aimed to determine the impact of weight gain prevention interventions on changes in cardiovascular risk factors over 6 years. Methods The Study of Novel Approaches to Weight Gain Prevention (SNAP) randomized 599 participants (ages 18-35; 46% with BMI 21-25; 54% with BMI 25-30) to Large Changes (produce buffer by losing 5-10 pounds initially), Small Changes (daily small changes in intake and activity) or Control and followed 355 participants with ongoing intervention and assessments through 6 years. Results There were no significant differences among interventions for changes in weight or cardiovascular disease (CVD) risk factors from baseline to 6 years. However, 44% of participants gained ≥5%, and only 14% lost ≥5% over 6 years. Weight changes, from baseline to year 6, were significantly associated with changes in risk factors, especially insulin and high-density lipoprotein cholesterol. Earlier weight changes (e.g., weight cycling) had no beneficial or adverse effect on changes in CVD risk factors at 6 years, independent of 6-year weight changes. Conclusions Despite participation in a weight gain prevention trial, almost half of these young adults gained ≥5% or more over 6 years, with significant worsening in CVD risk factors. Greater attention to long-term weight gain prevention in young adults is needed.

Introduction: Intentional weight loss is associated with lower risk of heart failure (HF) and atherosclerotic cardiovascular disease among patients with type 2 diabetes mellitus (T2DM). However, the contribution of changes in body composition measures [lean mass (LM), fat mass (FM), waist circumference (WC)] to the risk of HF and myocardial infarction (MI) is not well-known. Methods: Adults with T2DM who had overweight or obesity enrolled in the Look AHEAD (Action for Health in Diabetes) trial without prevalent HF were included. LM and FM were predicted using validated equations and compared with DXA measurements. Adjusted Cox models were used to evaluate the associations of baseline and longitudinal changes in LM, FM, and WC over 1- (Y0 to Y1) and 4-year (Y0 to Y4) follow-up with risk of overall HF, HF with preserved ejection fraction (HFpEF), HF with reduced ejection fraction (HFrEF) and MI. Results: Among 5,103 participants, there were 257 incident HF events over 12.4 years of follow-up. Predicted and measured LM and FM were highly correlated (R 2 =0.87-0.92). LM and FM decreased with greater declines in the intensive lifestyle intervention arm (Figure 1A). In adjusted analyses, baseline measures of body composition were not significantly associated with risk of HF. Decline in FM, but not LM, over 1- and 4-year follow-up was significantly associated with lower risk of HF (Figure 1B). A significant association was observed between decline in WC and risk of overall HF and HFpEF but not HFrEF. Among adults without a history of CVD, changes in body composition were not associated with risk of MI. Conclusions: In adults with T2DM who had overweight or obesity, a lifestyle intervention is associated with significant loss of FM and LM. Decline in FM and WC, but not LM, were each significantly associated with lower risk of HF but not MI. Furthermore, decline in WC was significantly associated with lower risk of HFpEF but not HFrEF.

Background: Intentional weight loss is associated with lower risk of heart failure (HF) and atherosclerotic cardiovascular disease among patients with type 2 diabetes. However, the contribution of baseline measures and longitudinal changes in fat mass (FM), lean mass (LM), and waist circumference (WC) to the risk of HF and myocardial infarction (MI) in type 2 diabetes is not well established. Methods: Adults from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included. FM and LM were predicted using validated equations and compared with dual-energy x-ray absorptiometry measurements in a subgroup. Adjusted Cox models were used to evaluate the associations of baseline and longitudinal changes in FM, LM, and WC over 1- and 4-year follow-up with risk of overall HF, HF with preserved ejection fraction (EF; EF ≥50%), HF with reduced EF (EF Results: Among 5103 participants, there were 257 incident HF events over 12.4 years of follow-up. Predicted and measured FM/LM were highly correlated ( R 2 =0.87–0.90; n=1369). FM and LM decreased over 4-year follow-up with greater declines in the intensive lifestyle intervention arm. In adjusted analysis, baseline body composition measures were not significantly associated with HF risk. Decline in FM and WC, but not LM, over 1 year were each significantly associated with lower risk of overall HF (adjusted hazard ratio per 10% decrease in FM, 0.80 [95% CI, 0.68–0.95]; adjusted hazard ratio per 10% decrease in WC, 0.77 [95% CI, 0.62–0.95]). Decline in FM was significantly associated with lower risk of both HF subtypes. In contrast, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Similar patterns of association were observed for 4-year changes in body composition and HF risk. Longitudinal changes in body composition were not significantly associated with risk of MI. Conclusions: In adults with type 2 diabetes, a lifestyle intervention is associated with significant loss of FM and LM. Declines in FM and WC, but not LM, were each significantly associated with lower risk of HF but not MI. Furthermore, decline in WC was significantly associated with lower risk of HF with preserved EF but not HF with reduced EF. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00017953.

Background: Type 2 diabetes mellitus (T2DM) is associated with a higher risk for heart failure (HF). The impact of a lifestyle intervention and changes in cardiorespiratory fitness (CRF) and body mass index on risk for HF is not well established. Methods: Participants from the Look AHEAD trial (Action for Health in Diabetes) without prevalent HF were included. Time-to-event analyses were used to compare the risk of incident HF between the intensive lifestyle intervention and diabetes support and education groups. The associations of baseline measures of CRF estimated from a maximal treadmill test, body mass index, and longitudinal changes in these parameters with risk of HF were evaluated with multivariable adjusted Cox models. Results: Among the 5109 trial participants, there was no significant difference in the risk of incident HF (n=257) between the intensive lifestyle intervention and the diabetes support and education groups (hazard ratio, 0.96 [95% CI, 0.75–1.23]) over a median follow-up of 12.4 years. In the most adjusted Cox models, the risk of HF was 39% and 62% lower among moderate fit (tertile 2: hazard ratio, 0.61 [95% CI, 0.44–0.83]) and high fit (tertile 3: hazard ratio, 0.38 [95% CI, 0.24–0.59]) groups, respectively (referent group: low fit, tertile 1). Among HF subtypes, after adjustment for traditional cardiovascular risk factors and interval incidence of myocardial infarction, baseline CRF was not significantly associated with risk of incident HF with reduced ejection fraction. In contrast, the risk of incident HF with preserved ejection fraction was 40% lower in the moderate fit group and 77% lower in the high fit group. Baseline body mass index also was not associated with risk of incident HF, HF with preserved ejection fraction, or HF with reduced ejection fraction after adjustment for CRF and traditional cardiovascular risk factors. Among participants with repeat CRF assessments (n=3902), improvements in CRF and weight loss over a 4-year follow-up were significantly associated with lower risk of HF (hazard ratio per 10% increase in CRF, 0.90 [95% CI, 0.82–0.99]; per 10% decrease in body mass index, 0.80 [95% CI, 0.69–0.94]). Conclusions: Among participants with type 2 diabetes mellitus in the Look AHEAD trial, the intensive lifestyle intervention did not appear to modify the risk of HF. Higher baseline CRF and sustained improvements in CRF and weight loss were associated with lower risk of HF. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00017953.

Introduction: Type 2 Diabetes (T2DM) is associated with higher risk for HF. The contributions of baseline measures of and changes in fitness (CRF) toward HF risk in T2DM is not well-established. Methods: Participants of the Look AHEAD trial without prevalent HF randomized to the intensive lifestyle intervention (ILI) vs. usual care arms were included. Incident HF hospitalization and its subtypes [HF with preserved ejection fraction (EF>= 50%, HFpEF) & HF with preserved ejection fraction (EF < 50%, HFrEF)] were adjudicated through the end of 2014 using a validated approach. The associations of baseline CRF estimated from a maximal treadmill test and changes in CRF (from baseline to year 4) with risk of HF and its subtypes were evaluated using adjusted Cox models. Results: Among the 5,109 study participants, there was no significant difference in the risk of HF (n = 257 events) between the ILI vs. usual care groups [HR (95% CI) = 0.96 (0.75 - 1.23)] over 12.4 years follow up. In adjusted analysis, the risk of HF was 39% and 62% lower among moderate fit [Tertile 2] and high fit [Tertile 3] groups, respectively [vs. low fit (Tertile 1), Table]. Among HF subtypes, the risk of HFpEF was 40% lower in moderate fit and 77% lower in the high fit groups (vs. low fit). In contrast, baseline CRF was not associated with risk of HFrEF after adjustment for potential confounders (Table). BMI was also not associated with risk of HF after adjustment for CV risk factors. Among participants with repeat CRF testing (n = 3,902), improvements in CRF and weight loss over 4-year follow-up was significantly associated with lower risk of HF [HR (95% CI) per 10% increase in CRF = 0.90 (0.82 to 0.99), per 10% decrease in BMI = 0.80 (0.69 to 0.94)]. Conclusion: Higher baseline CRF is independently associated with lower risk of HF, particularly HFpEF, among individuals with T2DM. Improvements in CRF and weight loss can significantly lower risk of HF in this high-risk population. However, the ILI implemented in the LookAHEAD trial did not modify the risk of HF among the study participants.

Background/objectives Type 2 diabetes mellitus and obesity are sometimes described as conditions that accelerate aging. Multidomain lifestyle interventions have shown promise to slow the accumulation of age-related diseases, a hallmark of aging. However, they have not been assessed among at-risk individuals with these two conditions. We examined the relative impact of 8 years of a multidomain lifestyle intervention on an index of multimorbidity. Design Randomized controlled clinical trial comparing an intensive lifestyle intervention (ILI) that targeted weight loss through caloric restriction and increased physical activity with a control condition of diabetes support and education (DSE). Setting Sixteen U.S. academic centers. Participants A total of 5,145 volunteers, aged 45 to 76, with established type 2 diabetes mellitus and overweight or obesity who met eligibility criteria for a randomized controlled clinical trial. Measurements A multimorbidity index that included nine age-related chronic diseases and death was tracked over 8 years of intervention delivery. Results Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98 (95% confidence interval [CI] = .94-1.02) over 8 years, compared with .89 (95% CI = .85-.93) among those in the multidomain ILI, which was a 9% difference (P = .003). Relative intervention effects were similar among individuals grouped by baseline body mass index, age, and sex, and they were greater for those with lower levels of multimorbidity index scores at baseline. Conclusions Increases in multimorbidity over time among adults with overweight or obesity and type 2 diabetes mellitus may be slowed by multidomain ILI. J Am Geriatr Soc 68:2249-2256, 2020.

Objective Weight gain occurs commonly in young adults and increases the risk of cardiovascular disease (CVD). Following on a previous report that two self-regulation interventions reduced weight gain relative to control, this study examines whether these interventions also benefit CVD risk factors. Methods The Study of Novel Approaches to Weight Gain Prevention was a randomized trial in two academic settings (N = 599; 18-35 years; BMI 21-30 kg/m2) comparing two interventions (Self-Regulation with Small Changes; Self-Regulation with Large Changes) and a control group. Small Changes taught participants to make daily small changes in calorie intake (approximately 100 calories) and activity. Large Changes taught participants to initially lose 5 to 10 pounds to buffer anticipated weight gains. CVD risk factors were assessed at baseline and at 2 years in 471 participants. Results Although Large Changes was associated with more beneficial changes in glucose, insulin, and homeostatic model assessment of insulin resistance than Control, these differences were not significant after adjusting for multiple comparisons or 2-year weight change. Comparison of participants grouped by percent weight change from baseline to 2 years showed significant differences for several CVD risk factors, with no interaction with treatment condition. Conclusions Magnitude of weight change, rather than specific weight gain prevention interventions, was related to changes in CVD risk factors in young adults.

Objective Self-regulation interventions encouraging daily weighing prevent weight gain in young adults; however, concerns have been raised that such interventions may have undesirable effects on eating pathology, depression, and health-related quality of life (HRQL). The present study examined whether self-regulation interventions and self-weighing frequency were associated with these indices in normal weight individuals and those with overweight or obesity. Methods Young adults (n = 599), 18-35 years with a body mass index (BMI) 21.0-30.9 kg/m² were randomized to control, self-regulation with small changes (SC) or self-regulation with large changes (LC). Interventions taught frequent self-weighing to guide behavioral changes. SC prescribed daily small decreases in intake and increases in physical activity. LC prescribed a 5- to 10-lb weight loss to buffer against anticipated gains. Psychological indices were assessed at baseline and periodically over 2 years of follow-up. Results There was no evidence that the interventions increased depressive symptoms or compensatory behaviors or decreased HRQL relative to control. LC increased flexible and rigid control and SC decreased disinhibition. Results did not differ by weight status with the exception of rigid control; here, differences between LC and the other conditions were smaller among those with BMI ≥ 25. Greater self-weighing frequency over time was associated with increases in flexible and rigid control, dietary restraint, and improvements in HRQL. Conclusions The self-regulation interventions and increases in self-weighing had no untoward effects. Encouraging weight gain prevention in young adults through frequent weighing and self-regulation appears to be safe for normal weight young adults and those with overweight. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Frequent self-weighing (daily or weekly) is consistently linked with weight management success but concerns persist about its potential association with unhealthy weight control practices. Although a number of studies have found evidence that frequent self-weighing is associated with better initial weight loss and prevention of weight gain or regain with no deleterious effects,(1–6) its use as a weight management strategy particularly among young adults is still viewed with caution. Whether this caution is justified is an important question that has not been adequately addressed. Concerns about frequent self-weighing have been primarily raised by those who study normal weight adolescents. Project EAT (7) followed a cohort of middle school and high school students and found that females who reported frequent weighing at baseline, compared to those who did not, were more likely to report binge eating and unhealthy weight control behaviors 5 years later. Frequent self-weighing has also been associated with depression and body dissatisfaction in studies with college age or young adults. (8–10) Conversely, studies of successful weight losers suggest that frequent self-weighing is part of a constellation of healthy weight control behaviors.(11) The National Weight Control Registry, a study of adults who have lost an average of 70 lb and kept it off 6 years, has identified frequent self-weighing as one of the key behaviors associated with initial weight loss success and long-term weight loss maintenance.(12, 13) Other behaviors in this constellation include consuming a low calorie, low fat diet, maintaining high levels of physical activity, regular consumption of breakfast, and exerting conscious control to maintain body weight. (14) Similarly, in adolescents who were successful at weight loss, Alm, et al. (15) found that frequent self-weighers (weekly or more often) reported using more healthy behavioral strategies, including decreasing calories, high fat foods, and junk foods and engaged in more strenuous activity and less video game play than those who weighed less often; they were not more prone to engage in unhealthy weight control behaviors.(16) To date, little has been published on the frequency of self-weighing in young adults age 18–35 and it is unclear whether frequent self-weighing is part of a constellation of healthy weight control behaviors or a potential marker of other unhealthy and disordered habits. The young adult population is of interest because they are at risk of major weight gain and the behaviors established during this critical developmental period are likely to persist into later adulthood. (17) We therefore determined the self-reported frequency of self-weighing in a cohort of almost 600 young adults at entry into a weight gain prevention study and examined the association of frequent self-weighing with a constellation of both healthy and unhealthy weight control behaviors.

Objective Weight gain occurs commonly in young adults and increases cardiovascular (CVD) risk. We previously reported that two self-regulation interventions reduced weight gain relative to control. Here we examine whether these interventions also benefit CVD risk factors. Methods SNAP (Study of Novel Approaches to Weight Gain Prevention) was a randomized trial in 2 academic settings (N=599; 18–35 years; body mass index 21–30 kg/m2) comparing two interventions (Self-Regulation with Small Changes; Self-Regulation with Large Changes) and Control. Small Changes taught participants to make daily small changes (approximately 100 calorie) in intake and activity. Large Changes taught participants to initially lose 5–10 pounds to buffer anticipated weight gains. CVD risk factors were assessed at baseline and 2 years in 471 participants. Results Although Large Changes was associated with more beneficial changes in glucose, insulin, and HOMA-IR than Control, these differences were not significant after adjusting for multiple comparisons or 2-year weight change. Comparison of participants grouped by percent weight change baseline to 2 years showed significant differences for several CVD risk factors, with no interaction with treatment condition. Conclusions Magnitude of weight change, rather than specific weight gain prevention interventions, was related to changes in CVD risk factors in young adults.

Aims/hypothesis The aim of this study was to evaluate the effects on diabetic peripheral neuropathy (DPN) of a long-term intensive lifestyle intervention (ILI) programme designed to achieve and maintain weight loss. Methods Beginning in 2001, a total of 5145 overweight or obese people with type 2 diabetes, aged 45–76 years, participating in the multicentre Look AHEAD (Action for Health in Diabetes) study were randomised to ILI (n = 2570) or to a diabetes support and education (DSE) control group (n = 2575) using a web-based management system at the study coordinating centre at Wake Forest School of Medicine (Winston-Salem, NC, USA). Randomisation was stratified by clinical centre and was not revealed to the clinical staff responsible for obtaining data on study outcomes. Because of the nature of the study, patients and the local centre interventionists were not blinded to the study group assignments. In addition, the coordinating centre staff members responsible for data management and statistical analyses were not blinded to the study group assignments. The interventions were terminated in September 2012, 9–11 years after randomisation, but both groups continued to be followed for both primary and secondary outcomes. Neuropathy evaluations included the Michigan Neuropathy Screening Instrument (MNSI) questionnaire completed at baseline in 5145 participants (ILI n = 2570, DSE n = 2575) and repeated annually thereafter and the MNSI physical examination and light touch sensation testing conducted in 3775 participants (ILI n = 1905, DSE n = 1870) 1–2.3 years after discontinuation of the intervention. Results At baseline, the MNSI questionnaire scores were 1.9 ± 0.04 and 1.8 ± 0.04 in the ILI and DSE groups, respectively (difference not statistically significant). After 1 year, when weight loss was maximal in the ILI group (8.6 ± 6.9%) compared with DSE (0.7 ± 4.8%), the respective MNSI scores were 1.7 ± 0.04 and 2.0 ± 0.04 (p ≤ 0.001). Subsequently, the scores increased gradually in both groups, but remained significantly lower in the ILI group for the first 3 years and at the end of follow-up. In both groups, there was a significant association between changes in the MNSI scores and changes in body weight, HbA1c and serum lipids. There were no significant between-group differences in the proportions of participants with MNSI physical examination scores ≥2.5, considered to be indicative of diabetic neuropathy. The light touch sensation measured separately in either the right or left big toes (halluces) did not differ between ILI and DSE, but when the data were combined for both toes, light touch was better preserved in the ILI group. Conclusions/interpretation ILI resulted in a significant decrease in questionnaire-based DPN, which was associated with the magnitude of weight loss. In both the ILI and DSE groups, changes in the MNSI score were also related to changes in HbA1c and lipids. There were no significant effects of ILI on physical examination measures of DPN conducted 1–2.3 years after termination of the active intervention, except for light touch sensation, which was significantly better in the ILI group when measurements were combined for both toes. However, a potential limiting factor to the interpretation of the physical examination data is that no baseline studies are available for comparison. Trial registration: ClinicalTrials.gov NCT00017953. Funding: This work was funded by the National Institutes of Health through cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases. Electronic supplementary material The online version of this article (doi:10.1007/s00125-017-4253-z) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

OBJECTIVE Sexual dysfunction is a prevalent problem in obese women with type 2 diabetes. This study examined the effects of intensive lifestyle intervention (ILI) in these women. RESEARCH DESIGN AND METHODS Look AHEAD is a 16-center, randomized, controlled trial evaluating the health effects of ILI compared with a control group (diabetes support and education [DSE]). The Look AHEAD Sexual Function Ancillary study included 375 female participants at five Look AHEAD sites. Participants completed the Female Sexual Function Inventory (FSFI) and Beck Depression Inventory (BDI), and assessments of weight and cardiovascular risk factors at baseline and 1 year were made. RESULTS At baseline, 50% of the 229 participants who reported being sexually active met criteria for female sexual dysfunction (FSD); only BDI score was related to FSD. One-year weight losses were greater in the ILI group than in the DSE group (7.6 vs. 0.45 kg; P < 0.001). Among women with FSD at baseline, those in the ILI group (N = 60) compared with those in the DSE group (N = 53) were significantly more likely to remain sexually active (83 vs. 64%; P < 0.008), reported greater improvement in total FSFI scores and in most FSFI domains (P < 0.05), and were more likely to experience remission of FSD (28 vs. 11%; P < 0.04) at 1 year. No significant differences between ILI and DSE were seen in women who did not have FSD at baseline. CONCLUSIONS Participation in ILI appeared to have beneficial effects on sexual functioning among obese women with diabetes, particularly in those who had FSD at baseline.

OBJECTIVE We examined maximal graded exercise test (GXT) results in 5,783 overweight/obese men and women, aged 45–76 years, with type 2 diabetes, who were entering the Look AHEAD (Action for Health in Diabetes) study, to determine the prevalence and correlates of exercise-induced cardiac abnormalities. RESEARCH DESIGN AND METHODS Participants underwent symptom-limited maximal GXTs. Questionnaires and physical examinations were used to determine demographic, anthropometric, metabolic, and health status predictors of abnormal GXT results, which were defined as an ST segment depression ≥1.0 mm, ventricular arrhythmia, angina pectoris, poor postexercise heart rate recovery ( RESULTS Exercise-induced abnormalities were present in 1,303 (22.5%) participants, of which 693 (12.0%) consisted of impaired exercise capacity. ST segment depression occurred in 440 (7.6%), abnormal heart rate recovery in 206 (5.0%), angina in 63 (1.1%), and arrhythmia in 41 (0.7%). Of potential predictors, only greater age was associated with increased prevalence of all abnormalities. Other predictors were associated with some, but not all, abnormalities. Systolic blood pressure response decreased with greater age, duration of diabetes, and history of cardiovascular disease. CONCLUSIONS We found a high rate of abnormal GXT results despite careful screening for cardiovascular disease symptoms. In this cohort of overweight and obese individuals with type 2 diabetes, greater age most consistently predicted abnormal GXT. Long-term follow-up of these participants will show whether these abnormalities are clinically significant.

Background Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. Purpose As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons Methods The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial’s interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared. Results Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. Limitations Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. Conclusions Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts. Clinical Trials 2009; 6: 416—429. http://ctj.sagepub.com

Determinants of erectile dysfunction in diabetic men have not been adequately investigated as potential mediators of change.To determine the prevalence and correlates of erectile dysfunction (ED) in overweight men with type 2 diabetes in the multicenter, Look AHEAD trial (Action for Health in Diabetes).International Index of Erectile Function (IIEF), self-reported use of phosphodiesterase type 5 inhibitors, laboratory measures of adiposity, cardiometabolic parameters, and exercise fitness.Male participants aged 45-75 in the Look AHEAD trial in a committed relationship were recruited for an ongoing study of sexual function and diabetes. Eligible participants completed the IIEF questionnaire and provided updated information on use of medical treatments for sexual dysfunction. Baseline sexual function results for participants in the male ancillary study are reported here; intervention data and results for female participants are presented elsewhere.A total of 373 eligible male participants completed all sexual function questionnaires, of whom 263 (68.7%) were sexually active at the time of the study. Almost half (49.8%) of the men reported mild or moderate degrees of ED, and 24.8% had complete ED. Among sexually active participants, 42.6% had sought medical help for their problem, and 39.7% reported use of ED medications. ED was significantly associated with age (odds ratio [OR] = 1.05; confidence interval [CI]: 1.01-1.10) baseline HbA(1c) (OR = 1.31; CI: 1.05-1.63), hypertension history (OR = 2.41; CI: 1.34-4.36), and metabolic syndrome (OR = 3.05, CI: 1.31-7.11). Of note, cardiorespiratory fitness was found to be protective of ED in a multivariable analysis (OR = 0.61; P0.001).ED is prevalent in this sample of obese, type 2 diabetic men in the Look AHEAD study. Cardiovascular risk factors were highly associated with ED in this population, and cardiorespiratory fitness was protective in this analysis.

Abstract Many protocols have been used in clinical and research settings for collecting systolic blood pressure (SBP) measurements to calculate the ankle–brachial index (ABI); however, it is not known how useful it is to replicate measurements and which measures best reflect cardiovascular risk. Standardized measurements of ankle and arm SBP from 5140 overweight or obese individuals with type 2 diabetes were used to estimate sources of variation. Measurement characteristics of leg-specific ABI, as calculated using a standard algorithm based on the highest SBP of the dorsalis pedis or posterior tibial arteries, were projected using simulations. Coefficients of variability ranged from 2% to 3% when single SBP measurements were used and ABI was overestimated by 2–3%. Taking two SBP measurements at each site reduced standard errors and bias each by 30–40%. The sensitivity of detecting low ABI ranges exceeded 90% for ABI within 0.05 of the 0.90 clinical cut-point. The average and the minimum of the two (i.e. right and left) leg-specific ABI values had similar U-shaped relationships with Framingham risk scores; however, the average leg ABI had slightly greater precision. Replicating SBP measurements reduces the error and bias of ABI. Averaging leg-specific values may increase power for characterizing cardiovascular disease risk.

OBJECTIVE— We examined associations of cardiovascular, metabolic, and body composition measures with exercise capacity using baseline data from 5,145 overweight and/or obese (BMI ≥25.0 kg/m2) men and women with type 2 diabetes who were randomized participants for the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS— Peak exercise capacity expressed as METs and estimated from treadmill speed and grade was measured during a graded exercise test designed to elicit a maximal effort. Other measures included waist circumference, BMI, type 2 diabetes duration, types of medication used, A1C, history of cardiovascular disease, metabolic syndrome, β-blocker use, and race/ethnicity. RESULTS— Peak exercise capacity was higher for men (8.0 ± 2.1 METs) than for women (6.7 ± 1.7 METs) (P < 0.001). Exercise capacity also decreased across each decade of age (P < 0.001) and with increasing BMI and waist circumference levels in both sexes. Older age, increased waist circumference and BMI, a longer duration of diabetes, increased A1C, a history of cardiovascular disease, having metabolic syndrome, β-blocker use, and being African American compared with being Caucasian were associated with a lower peak exercise capacity for both sexes. Hypertension and use of diabetes medications were associated with lower peak exercise capacity in women. CONCLUSIONS— Individuals with diabetes who are overweight or obese have impaired exercise capacity, which is primarily related to age, female sex, and race, as well as poor metabolic control, BMI, and central obesity.

Introduction: Young adults gain an average of 2 pounds per year, increasing their risk for obesity and co-morbidities. To date, no approaches have successfully reduced this weight gain. The Study of Novel Approaches to Prevention of Weight Gain (SNAP) is a randomized clinical trial testing two innovative self-regulation interventions. Hypothesis: We hypothesized that both interventions would reduce weight change over an average follow-up of 3 years relative to a control. Methods: Participants age 18-35 with a BMI of 21-30 were recruited in Raleigh-Durham, NC and Providence, RI. The 599 participants included 27% from minority groups and 22% males, mean age 28.4 (SD 4.4) yrs and BMI 25.4 (2.6). The interventions were based on a self-regulation model, involving frequent self-weighing and changes in eating and activity if weight gain occurred. The SMALL changes approach focused on making small (100 calorie) changes in daily eating and exercise; LARGE changes emphasized larger initial changes in eating and exercise, to create a 5 to 10-pound buffer against anticipated weight gain. Interventions were delivered via 8 face-to-face group sessions in the first 4 months, followed by ongoing weight reporting and feedback and optional Internet refreshers. CONTROL received one face-to-face session. Assessments were at baseline, 4 months, and then annually. Results: Data collection ends 12/31/14; final results will be presented. Retention at year 3 is 87%. Currently, mean (SE) weight changes across 3 years differ significantly between the groups (see Fig 1); for LARGE, mean weight loss is -2.48 (0.22) kg, which differs significantly from -0.75 (0.22) kg loss in SMALL, and both differ from the +0.10 (0.22) kg gain in Control. For secondary outcomes of weight gain from baseline to 2 years and % gaining >1 lb at 2 years, both interventions significantly differed from Control, but not from each other. Conclusion: Self-regulation approaches using LARGE or SMALL change strategies reduce weight gain in young adults.

Objective Frequent self-weighing is linked with weight management success but concern has been raised about its possible association with unhealthy practices. We examined the association of self-weighing with other weight control behaviors in a sample for whom frequent weighing might be questioned—namely normal weight or overweight (BMI of 21–29.9) young adults (age 18–35). Design and Methods Participants (N=583; mean [SD] age= 27.7 [4.4]; BMI=25.4 [2.6]) entering the Study of Novel Approaches to Weight Gain Prevention (SNAP) completed objective measures of weight and physical activity and self-reported weight history, use of healthy and unhealthy weight control strategies, depressive symptoms, and dietary intake. Results Daily self-weighing was reported by 11% of participants and 23% weighed several times per week. Frequent weighing was not associated with current BMI, gender or age, but was associated with being further below one’s highest weight, history of dieting, and perceived difficulty maintaining weight. Frequent weighing was associated with number of healthy weight management strategies but not with unhealthy practices or depressive symptoms. Conclusions In this sample, frequent self-weighing appears to be part of a constellation of healthy weight control behaviors used to counteract a perceived tendency toward weight gain. SNAP follow-up will determine whether frequent self-weighing helps prevent weight gain.

Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes.Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953.Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events.Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.National Institute of Diabetes and Digestive and Kidney Diseases.

To examine whether a subjective measure of moderate-intensity exercise (12-13 on Borg's ratings of perceived exertion scale; RPE) corresponds to the target heart rate for moderate-intensity exercise (40-59% heart rate reserve; %HRR) and to determine the characteristics of those for whom RPE does not appropriately estimate exercise intensity.3582 individuals with type 2 diabetes (age: 58.3±6.8 years; BMI: 35.9±5.9 kg/mAt an RPE of 12 or 13, 57% of participants fell within the target 40-59%HRR range, while 37% and 6% fell above and below this range, respectively. Participants with a %HRR ≥60% (above range) were more likely to be female (OR: 1.19; 95% CI: 1.01,1.40), African American (OR: 1.65; 95% CI: 1.35, 2.02) or Hispanic (OR: 1.57; 95% CI: 1.27, 1.95), have a higher BMI (OR: 1.03; 95% CI 1.01, 1.04) and HRRPE appropriately gauges exercise intensity in approximately half of overweight individuals with type 2 diabetes; however, more than one-third of participants were at an increased risk of exercising at a higher than prescribed intensity when using RPE. Future studies should continue to examine the characteristics of individuals for whom RPE appropriately estimates exercise intensity and for those whom it does not.

Look AHEAD (Action for Health in Diabetes) was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow-up of 9.6 years was not reduced in the Intensive Lifestyle Group relative to the control group. This finding is discussed, with emphasis on its implications for design of trials and clinical treatment of obese persons with type 2 diabetes.

PURPOSE: To characterize the distribution of errors in self-reported sodium and potassium dietary intakes relative to more objective urine measures among participants receiving lifestyle interventions. METHODS: We analyzed longitudinal data from 900 individuals with hypertension who had been enrolled in a randomized controlled clinical trial to establish whether usual care or three lifestyle interventions (weight loss, sodium reduction, and combined weight loss and sodium reduction) could effectively substitute for phamacotherapy. Repeated standardized 24-hour diet recalls and 24-hour urine collections were collected over up to three years of follow-up to estimate sodium and potassium intakes. By contrasting self-reported and urine-based sodium and potassium data collected before and during interventions, we examined the relative impact of intervention assignment on estimated intakes, repeatability, and multivariate measurement error. RESULTS: Relative to urine-based measures, mean self-reported sodium intakes were biased about 10% lower among participants assigned to combined weight loss and sodium reduction, but were unaffected by the other interventions. The repeatability of self-report measures increased slightly with time, particularly among participants assigned to sodium interventions. Errors in self-reported sodium and potassium intakes were correlated before the start of the intervention, but became uncorrelated among individuals assigned to sodium restriction interventions. CONCLUSIONS: Lifestyle interventions may influence not only diet intake, but also the measurement of diet intake.

BACKGROUND National guidelines recommend consideration of step down or withdrawal of medication in patients with well-controlled hypertension, but knowledge of factors that predict or mediate success in achieving this goal is limited. OBJECTIVE To identify patient characteristics associated with success in controlling blood pressure (BP) after withdrawal of antihypertensive medication. DESIGN The Trial of Nonpharmacologic Interventions in the Elderly tested whether lifestyle interventions designed to promote weight loss or a reduced intake of sodium, alone or in combination, provided satisfactory BP control among elderly patients (aged 60-80 years) with hypertension after withdrawal from antihypertensive drug therapy. Participants were observed for 15 to 36 months after attempted drug withdrawal. MAIN OUTCOME MEASURES Trial end points were defined by (1) a sustained BP of 150/90 mm Hg or higher, (2) a clinical cardiovascular event, or (3) a decision by participants or their personal physicians to resume BP medication. RESULTS Proportional hazards regression analyses indicated that the hazard (+/- SE) of experiencing an end point among persons assigned to active interventions was 75% +/- 9% (weight loss), 68% +/- 7% (sodium reduction), and 55% +/- 7% (combined weight loss/sodium reduction) that of the hazard for those assigned to usual care. Lower baseline systolic BP (P < .001), fewer years since diagnosis of hypertension (P < .001), fewer years of antihypertensive treatment (P < .001), and no history of cardiovascular disease (P = .01) were important predictors of maintaining successful nonpharmacological BP control throughout follow-up, based on logistic regression analysis. Age, ethnicity, baseline level of physical activity baseline weight, medication class, smoking status, and alcohol intake were not statistically significant predictors. During follow-up, the extent of weight loss (P = .001) and urinary sodium excretion (P = .04) were associated with a reduction in the risk of trial end points in a graded fashion. CONCLUSIONS Withdrawal from antihypertensive medication is most likely to be successful in patients with well-controlled hypertension who have been recently (within 5 years) diagnosed or treated, and who adhere to life-style interventions involving weight loss and sodium reduction. More than 80% of these patients may have success in medication withdrawal for longer than 1 year.

OBJECTIVE: To compare the effectiveness of different approaches to participant enrollment in a behavior modification trial. DESIGN: Concurrent, prospective evaluation performed in context of recruitment for a randomized, controlled trial. SETTING: Four study centers located in Baltimore, Maryland, Memphis, Tennessee New Brunswick, New Jersey, and Winston-Salem, North Carolina. PARTICIPANTS: Men and women aged 60 to 80 years who were being treated with a prescription medication for control of hypertension. MAIN OUTCOME MEASURES: Visit counts and percent yields were assessed at each stage of the screening and randomization process. Logistic regression was used to contrast the randomization yields for different recruitment strategies and to explore the impact of sociodemographic characteristics and geographic location on recruitment yields RESULTS: The overall randomization yields from a pre-screen contact and a first screening visit to enrollment in the trial were 11% and 31%, respectively. Randomization yields varied significantly by participant age, education, and marital status. CONCLUSIONS: Our results demonstrate the feasibility of recruitment for trials of nonpharmacologic interventions in older people and suggest that mass mailing and mass media advertising campaigns provide an effective means of enrolling in such studies participants with a broad range of personal characteristics.

OBJECTIVES: To examine the distribution and correlates of the classes of antihypertensive medications taken by persons aged 60 to 80. DESIGN: Cross-sectional screening. SETTING: Four academic medical centers in the southern and eastern United States. PARTICIPANTS: Volunteers (N = 2601) entering a clinical trial testing the value of nonpharmacologic approaches to control blood pressure who were either taking one or two (single or combined) medications for the treatment of hypertension and expressed willingness to be withdrawn from these medications according to a standardized protocol MEASUREMENTS: Medication use, blood pressure, and data from self-administered questionnaires collected during standardized clinic visits. RESULTS: Calcium channel blockers (23.9%) were the most frequent single agent antihypertensive medications used by cohort members, followed by diuretics (17.9%) and angiotensin-converting enzyme (ACE) inhibitors (17.5%). The most common combination agents were composed of diuretics with either calcium channel blockers (5.4%), ACE inhibitors (4.0%), or β-blockers (3.7%). Women were twice as likely to be taking diuretics, and less likely to be taking ACE inhibitors and β-blockers, than men. Blacks were more likely to be taking diuretics and calcium channel blockers, and less likely to be taking β-blockers and ACE inhibitors, than others. These relationships could not be attributed to differences in geographical area, other demographic factors, age, or medical history. CONCLUSIONS: These usage patterns appear to mirror those in the population of the United States as a whole, which has trended toward greater usage of calcium channel blockers and ACE inhibitors with declining use of diuretics. The distribution of antihypertensive medications among older hypertensives is markedly different between women and men and between black Americans and others.

Weight gain occurs commonly in young adults and has adverse effects on health.To compare 2 self-regulation interventions vs control in reducing weight gain in young adults over a mean follow-up of 3 years.Randomized clinical trial in 2 academic settings of 599 participants aged 18 to 35 years with body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 21.0 to 30.0, recruited via mailings and emails from August 2010 to February 2012. Data were analyzed from January 2015 to January 2016.Participants were randomized to control, self-regulation plus small changes, or self-regulation plus large changes. Both interventions focused on frequent self-weighing to cue behavior changes. "Small changes" taught participants to reduce intake and increase activity, both by approximately 100 calories per day. "Large changes" focused on losing 2.3 to 4.5 kg initially to buffer against expected weight gain.Changes in weight from baseline over mean follow-up of 3 years. Secondary outcomes included proportion gaining at least 0.45 kg from baseline, proportion developing obesity (BMI, ≥30.0), and weight change baseline to 2 years.Among the 599 participants (22% men; 27% minority; mean [SD] age, 27.7 [4.4] years; mean [SD] BMI, 25.4 [2.6]), mean (SE) weight changes over a mean follow-up of 3 years were 0.26 (0.22), -0.56 (0.22), and -2.37 (0.22) kg in the control, small-changes, and large-changes groups, respectively (P .001). Differences among all 3 groups were significant (large changes vs control, P .001; small changes vs control, P = .02; large changes vs small changes, P .001). On secondary outcomes, both interventions significantly reduced incidence of obesity relative to control (mean [SE], 8.6% [2.0%], 7.9% [2.0%], and 16.9% [2.7%] in the large-changes, small-changes, and control groups, respectively; P = .02 for large changes vs control and P = .002 for small changes vs control); a smaller percentage of participants in the large-changes group gained 0.45 kg or more (mean [SE], 23.6% [2.8%], 32.5% [3.8%], and 40.8% [4.4%], respectively; P .001 vs control and P = .02 vs small changes) and weight change from baseline to 2 years was greater in control than in small or large changes (mean [SE], 0.54 [0.33], -0.77 [0.33], and -1.50 [0.34] kg, respectively; P = .02 vs small changes and P .001 vs large changes).Self-regulation with large or small changes both reduced weight gain in young adults over 3 years relative to control, but the large-changes intervention was more effective.clinicaltrials.gov Identifier: NCT01183689.

The Forsyth County Cervical Cancer Prevention Project was a 5 year National Cancer Institute-funded community-based public health education program implemented to address the problem of excess mortality from cervical cancer among black women in Forsyth County, North Carolina. The intervention was a community-based public health education program that included mass media, direct education workshops, and provision of education on cervical cancer and screening to health care providers. The intervention was implemented from November 1988 to September 1991. Evaluation of the community intervention used a quasi-experimental design, with Forsyth County, North Carolina, receiving the program and Durham County, North Carolina, serving as the control. Comparison of pre- and post-intervention telephone survey data revealed that, overall, awareness of cervical cancer and the Pap smear increased. Knowledge, attitudes and behaviors showed little change, considering those interviewed in aggregate. Among women defined as high-risk (elderly, low socioeconomic status, public health clinic patients and/or those who do not receive regular care), a significant trend toward greater participation in screening was detected for the 6 month period following the intervention. These results suggest that awareness of cervical cancer can be increased by public health education, but that the additional attention coming to patients through the actions of health care providers and health care delivery systems may supply the additional input needed to produce behavior change.

BACKGROUND Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

OBJECTIVE We examined maximal graded exercise test (GXT) results in 5,783 overweight/obese men and women, aged 45–76 years, with type 2 diabetes, who were entering the Look AHEAD (Action for Health in Diabetes) study, to determine the prevalence and correlates of exercise-induced cardiac abnormalities. RESEARCH DESIGN AND METHODS Participants underwent symptom-limited maximal GXTs. Questionnaires and physical examinations were used to determine demographic, anthropometric, metabolic, and health status predictors of abnormal GXT results, which were defined as an ST segment depression ≥1.0 mm, ventricular arrhythmia, angina pectoris, poor postexercise heart rate recovery (

The Forsyth County Cervical Cancer Prevention Project (FCP) is a community-based health education project funded by the National Cancer Institute. The target population includes around 25 000 black women age 18 and older who reside in Forsyth County, North Carolina. The overall goal of the program is to prevent mortality from cervical cancer by promoting Pap smears and return for follow-up care when needed. Based on the principles of social marketing, a plan to reach the target population with mass media educational messages through electronic and print channels was developed. Guided by marketing objectives, the target population was divided into relatively discrete segments. The segments included church attenders, patients in waiting rooms of public and selected health providers, female students at local colleges, shoppers, viewers of radio and television, newspaper readers, and business owners and managers. Introduction of the program was based on strategies developed for reaching the target population in each segment with television, radio and print mass media messages. Qualitative assessment of the mass media developed by the program indicated that all forms of communication helped to increase awareness of the program.

We examined associations of cardiovascular, metabolic, and body composition measures with exercise capacity using baseline data from 5,145 overweight and/or obese (BMIor = 25.0 kg/m2) men and women with type 2 diabetes who were randomized participants for the Look AHEAD (Action for Health in Diabetes) clinical trial.Peak exercise capacity expressed as METs and estimated from treadmill speed and grade was measured during a graded exercise test designed to elicit a maximal effort. Other measures included waist circumference, BMI, type 2 diabetes duration, types of medication used, A1C, history of cardiovascular disease, metabolic syndrome, beta-blocker use, and race/ethnicity.Peak exercise capacity was higher for men (8.0 +/- 2.1 METs) than for women (6.7 +/- 1.7 METs) (P0.001). Exercise capacity also decreased across each decade of age (P0.001) and with increasing BMI and waist circumference levels in both sexes. Older age, increased waist circumference and BMI, a longer duration of diabetes, increased A1C, a history of cardiovascular disease, having metabolic syndrome, beta-blocker use, and being African American compared with being Caucasian were associated with a lower peak exercise capacity for both sexes. Hypertension and use of diabetes medications were associated with lower peak exercise capacity in women.Individuals with diabetes who are overweight or obese have impaired exercise capacity, which is primarily related to age, female sex, and race, as well as poor metabolic control, BMI, and central obesity.

Background Obesity is associated with higher risk of atrial fibrillation (AF), but the impact of behavioral weight loss interventions on atrial fibrillation (AF) risk in persons with diabetes is unknown. We addressed this question in the Look AHEAD randomized trial. Methods and results A total of 5,067 overweight or obese individuals 45 to 76 years old with type 2 diabetes without prevalent AF were randomized to either an intensive lifestyle intervention (ILI) designed to achieve and maintain weight loss through caloric reduction and increased physical activity or a diabetes support and education usual care group. Atrial fibrillation was ascertained from electrocardiograms at study examinations and hospitalization discharge summaries. Multivariable Cox models were used to estimate the intention-to-treat effect of the intervention adjusting for baseline covariates. During a mean follow-up of 9.0 years, 294 incident AF cases were identified. Rates of AF were comparable in the ILI and diabetes support and education groups (6.1 and 6.7 cases per 1,000 person-years, respectively, P = .42). The intervention did not affect AF incidence (multivariable hazard ratio [HR] 0.99, 95% CI 0.77-1.28). Similarly, neither weight loss nor improvement in physical fitness during the first year of the intervention was significantly associated with AF incidence: multivariable hazard ratio (95% CI) comparing top versus bottom quartile was 0.70 (0.41-1.18) for weight loss and 0.88 (0.55-1.43) for physical fitness improvement. Conclusion In a large randomized trial of overweight and obese individuals with type 2 diabetes, an ILI that induced modest weight loss did not reduce the risk of developing AF.