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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

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.

Background Young adults (YA) are at high-risk for unhealthy dietary behaviors and weight gain. The Study of Novel Approaches to Weight Gain Prevention (SNAP) Trial demonstrated that two self-regulation approaches were effective in reducing weight gain over 2 years compared with control. The goal of this analysis was to examine effects of intervention on dietary outcomes and the association of diet changes with weight change. Methods Participants were 599 YA, age 18–35 years, BMI 21.0–30.0 kg/m2 (27.4 ± 4.4 years; 25.4 ± 2.6 kg/m2; 22% men; 73% non-Hispanic White), who were recruited in Providence, RI and Chapel Hill, NC and randomized to self-regulation with Small Changes (SC), self-regulation with Large Changes (LC) or Control (C). SC and LC emphasized frequent self-weighing to cue behavior changes (small daily changes vs. periodic large changes) and targeted high-risk dietary behaviors. Diet and weight were assessed at baseline, 4 months and 2 years. Results LC and SC had greater decreases in energy intake than C at 4 months but not 2 years. LC had the greatest changes in percent calories from fat at 4 months, but differences were attenuated at 2 years. No differences in diet quality were observed. Across conditions, increased total energy consumption, fast food, meals away from home, and binge drinking, and decreased dietary quality and breakfast consumption were all associated with weight gain at 2 years. Conclusions This study suggests the need to strengthen interventions to produce longer term changes in dietary intake and helps to identify specific behaviors associated with weight gain over time in young adults. Trial registration Clinicaltrials.gov #NCT01183689, registered August 18, 2010.

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.

The prevalence of overweight and obesity in U.S. adults now exceeds 65% (Flegal, Carroll, Ogden, & Curtin, 2010) with current estimates suggesting that the entire U.S. adult population will reach an unhealthy weight status by 2048 (Wang, Beydoun, Liang, Caballero, & Kumanyika, 2008). Drivers of this trend are multi-faceted, ranging from individual behavioral choices to community land-use planning decisions to global food production practices that promote energy imbalance (e.g., Swinburn et al., 2011). Behavioral weight loss treatment (BWL), the treatment of choice for overweight to moderately obese individuals, includes nutrition and physical activity education and instruction in behavioral strategies to facilitate change, and produces weight losses of approximately 9.0 kg over 6 months of treatment (e.g., Wing, Gorin, & Tate, 2006). While BWL’s modest weight losses and accompanying physical activity and dietary changes produce meaningful health improvements (e.g., Diabetes Prevention Program Research Group, 2002; Look AHEAD Research Group, 2007), participants typically regain 30–50% of their weight loss over the next 3 to 5 years despite ongoing intervention (e.g., Look AHEAD Research Group, 2010). One possible explanation for this weight regain is that BWL focuses primarily on the individual participant, with lesser attention paid to the environmental context in which eating and exercise occurs. While behavioral theory and early weight loss programs emphasized the impact of environmental antecedents and consequences on behavior (e.g., Stuart & Davis, 1972), in current practice, individuals are given limited instruction on how to modify their surroundings to support weight-regulating behaviors. In a standard 6-month program, 1 to 2 sessions are typically dedicated to stimulus control skills (e.g. placing fruits and vegetables in prominent locations), (Wing, Gorin, & Tate, 2006). If weight loss participants are unable to use these skills to alter their personal environments, unhealthy cues and temptations may remain making it extremely difficult to establish and maintain the behavioral changes necessary to produce long-term weight loss (e.g., Bouton, 2000; Lowe, 2003). This individual-level approach to weight management is inconsistent with the growing recognition of the environment’s contribution to the obesity epidemic (e.g., French, Story, & Jeffery, 2001; Swinburn et al., 2011). American adults are described as living in a “toxic environment” that encourages passive overeating and physical inactivity (Wang & Brownell, 2005). Social ecological models of health promotion (Breslow, 1996; Stokols, 2000) identify several levels of environmental influence on diet and physical activity, ranging from familial to global factors. At the most proximal level, there is increasing evidence that the home microenvironment can be obesogenic. Both physical (e.g., type of food available) and social (e.g., support from family) factors in this setting have been associated with weight, dietary habits, and activity patterns (e.g., Campbell, Crawford, Salmon, Carver, Garnett, & Baur, 2007; Gorin, Phelan, Raynor, & Wing, 2011). Demonstrated links between the physical home environment and behavior include relationships between high fat foods available and fat intake (Fulkerson et al., 2008), access to home exercise equipment and activity levels (Gattshall et al., 2008; Jakicic, Wing, Butler, & Jeffery, 1997), and number of televisions and amount of TV viewing (Dennison, Erb, & Jenkins, 2002). With regards to social factors, adults within the same household can serve as powerful behavioral cues and either facilitate or hinder adoption of healthy habits. For example, both weight gain and weight loss appear to spread among spouses (Christakis & Fowler, 2007; Gorin et al., 2008) and correlations have been reported between husbands and wives in caloric intake, dietary restraint, and exercise frequency (e.g., Macken et al., 2000; Markey, Markey, & Birch, 2001). Given that approximately two-thirds of daily calories are consumed in the home and a large percentage of leisure time is spent in this environment (Biing-Hwan, Geuthri, & Frazao, 1999; Robinson & Godbey, 1997), modifying households to promote healthy choices is a logical step in moving toward a broader ecological model of weight management. Weight loss programs that have included home environment modifications such as food provision, provision of exercise equipment, and involving spouses in treatment have produced better overall weight losses for up to 18 months than standard behavioral programs, particularly in women (Black, Gleser, & Kooyers, 1990; Jakicic, Winters, Lang, & Wing, 1999); however these strategies have been largely unsuccessful in producing better maintenance of weight loss. Environmental manipulations to date have typically focused on either a single physical factor in the home (such as provision of food or exercise equipment) or on the social climate of the home (spouse involvement in treatment). This singular focus may not change the overall obesogenic nature of the household, leaving participants vulnerable to environmental influence. Moreover, this singular focus does not address the interaction between physical and social factors within the home (e.g., food provision may be unsuccessful if family members bring tempting foods into the home). Ecological models suggest that interventions will be most effective in changing behavior if they address multiple factors within a given environment, thus to examine the true potential of home environment manipulations in obesity treatment, a more comprehensive intervention targeting several aspects within the household may be needed. The primary aim of this randomized controlled trial was to examine the long-term impact of a comprehensive home-focused behavioral weight control program designed to directly modify both the physical and social home environments of weight loss participants. To our knowledge, this is the first weight loss program to intervene simultaneously on multiple levels of the home environment while also teaching participants core behavioral skills. We hypothesized that by extending the focus of treatment from the individual participant to the participant plus their home environment, the intervention would enhance initial and long-term weight loss outcomes and improve maintenance of weight loss compared to standard behavioral weight loss treatment. Prior research has suggested that women may benefit more from a home-based approach (Wing, Marcus, Epstein, & Jawad, 1991), thus secondary analyses explored gender as a potential treatment moderator. We also examined potential effects on household partners and hypothesized that greater weight loss and behavior changes would be observed in partners who were actively included in the intervention.

SummaryObjective Emerging adults ages 18–25 are at high risk for obesity, but are markedly underrepresented in behavioural weight loss (BWL) programs and experience lower engagement and retention relative to older adults. Purpose To utilize a mixed methods approach to inform future efforts to effectively recruit and engage this high-risk population in BWL programs. Methods We used a convergent parallel design in which quantitative and qualitative data were given equal priority. Study 1 (N = 137, age = 21.8 + 2.2, BMI = 30.1 + 4.7) was a quantitative survey, conducted online to reduce known barriers and minimize bias. Study 2 (N = 7 groups, age = 22.3 + 2.2, BMI = 31.5 + 4.6) was a qualitative study, consisting of in person focus groups to gain greater depth and identify contextual factors unable to be captured in Study 1. Results Weight loss was of interest, but weight itself was not a central motivation; an emphasis on overall lifestyle, self-improvement and fitness emerged as driving factors. Key barriers were time, motivation and money. Recruitment processes should be primarily online with messages tailored specifically to motivations and preferences of this age group. Preferences for a program were reduced intensity and brief, hybrid format with some in-person contact, individual level coaching, experiential learning and peer support. Key methods of promoting engagement and retention were autonomy and choice, money and creating an optimal default. Conclusions An individually tailored lifestyle intervention that addresses a spectrum of health behaviours, promotes autonomy and emphasizes activity and fitness may facilitate recruitment and engagement in this population better than traditional BWL protocols.

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.

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: The purpose of this study was to examine the effect of weight cycling (as defined by the frequency and magnitude of intentional weight loss) on bone mineral density and bone mineral content in obese sedentary women. Research Methods and Procedures: Bone mineral content and density measured by DXA, submaximal physical fitness assessment, nutrient intake, oral contraceptive use, and weight-cycling history were assessed in 195 healthy, overweight sedentary women (age, 21 to 45 years; body mass index, 27 to 40 kg/m2) before beginning a behavioral weight-loss intervention. Results: After controlling for body weight, multivitamin use, oral contraceptive/estrogen use, and calcium and magnesium intake, women who had a history of weight cycling did not have significantly lower total-body bone mineral content or density or total femur bone mineral density. In addition, 99% of subjects were above or within one SD of age and gender normative data for total femur bone mineral density. Discussion: It does not seem that a history of weight cycling has an adverse affect on total femur and total-body bone mineral density in overweight sedentary premenopausal women.

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.

Young adulthood (age 18 to 35) is a high-risk period for unhealthy weight gain. Few studies have recruited for prevention of weight gain, particularly in young adults. This paper describes the recruitment protocol used in the Study of Novel Approaches to Prevention (SNAP). We conducted extensive formative work to inform recruitment methods and message development. We worked with a professional marketing firm to synthesize major themes and subsequently develop age-appropriate messages for recruitment. A variety of approaches and channels were used across two clinical centers to recruit young adults who were normal or overweight (body mass index (BMI) 21 to 30 kg/m2) for a 3-year intervention designed to prevent weight gain. We tracked recruitment methods, yields, and costs by method. Logistic regression was used to identify recruitment methods that had the highest relative yield for subgroups of interest with covariate adjustments for clinic. The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period of sustained efforts. About 10% of those who initially expressed interest via a screening website were randomized. The most common reason for ineligibility was already being obese (BMI >30 kg/m2). The top two methods for recruitment were mass mailing followed by email; together they were cited by 62% of those recruited. Television, radio, paid print advertising, flyers and community events each yielded fewer than 10% of study participants. Email was the most cost-effective method per study participant recruited. These findings can guide future efforts to recruit young adults and for trials targeting weight gain prevention. ClinicalTrials.gov NCT01183689 (registered 13 August 2010).

Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention. Objective To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at 12 months. Design A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at 0 and 12 months. Participants/setting From 16 US sites, the first 50% of participants (aged 45 to 76 years, overweight or obese, with type 2 diabetes) were invited to complete dietary assessments. Complete 0- and 12-month dietary assessments (collected between 2001 and 2004) were available for 2,397 participants (46.6% of total participants), with 1,186 randomized to Diabetes Support and Education group and 1,211 randomized to Intensive Lifestyle Intervention group. Main outcome measures A food frequency questionnaire assessed intake: energy; percent energy from protein, fat, carbohydrate, polyunsaturated fatty acids, and saturated fats; trans -fatty acids; cholesterol; fiber; weekly meal replacements; and daily servings from food groups from the Food Guide Pyramid. Statistical analyses performed Mixed-factor analyses of covariance, using Proc MIXED with a repeated statement, with age, sex, race/ethnicity, education, and income controlled. Unadjusted χ 2 tests compared percent meeting fat-related and food group recommendations at 12 months. Results At 12 months, Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants. Intensive Lifestyle Intervention participants consumed more servings per day of fruits; vegetables; and milk, yogurt, and cheese; and fewer servings per day of fats, oils, and sweets than Diabetes Support and Education participants. A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations. Within Intensive Lifestyle Intervention, a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations. Conclusions The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality.

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.

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.

Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.

Background Weight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young adults compared to a minimal treatment control. The interventions focus on either small, consistent changes in eating and exercise behaviors, or larger, periodic changes to buffer against expected weight gains. Methods/Design SNAP targets recruitment of six hundred young adults (18–35 years) with a body mass index between 21.0-30.0 kg/m2, who will be randomly assigned with equal probability to: (1) minimal intervention control; (2) self-regulation with Small Changes; or (3) self-regulation with Large Changes. Both interventions receive 8 weekly face-to-face group sessions, followed by 2 monthly sessions, with two 4-week refresher courses in each of subsequent years. Participants are instructed to report weight via web at least monthly thereafter, and receive monthly email feedback. Participants in Small Changes are taught to make small daily changes (~100 calorie changes) in how much or what they eat and to accumulate 2000 additional steps per day. Participants in Large Changes are taught to create a weight loss buffer of 5–10 pounds once per year to protect against anticipated weight gains. Both groups are encouraged to self-weigh daily and taught a self-regulation color zone system that specifies action depending on weight gain prevention success. Individualized treatment contact is offered to participants who report weight gains. Participants are assessed at baseline, 4 months, and then annually. The primary outcome is weight gain over an average of 3 years of follow-up; secondary outcomes include diet and physical activity behaviors, psychosocial measures, and cardiovascular disease risk factors. Discussion SNAP is unique in its focus on weight gain prevention in young adulthood. The trial will provide important information about whether either or both of these novel interventions are effective in preventing weight gain. Trial registration ClinicalTrials.gov, NCT01183689

Background Weight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young adults compared to a minimal treatment control. The interventions focus on either small, consistent changes in eating and exercise behaviors, or larger, periodic changes to buffer against expected weight gains. Methods/Design SNAP targets recruitment of six hundred young adults (18–35 years) with a body mass index between 21.0-30.0 kg/m2, who will be randomly assigned with equal probability to: (1) minimal intervention control; (2) self-regulation with Small Changes; or (3) self-regulation with Large Changes. Both interventions receive 8 weekly face-to-face group sessions, followed by 2 monthly sessions, with two 4-week refresher courses in each of subsequent years. Participants are instructed to report weight via web at least monthly thereafter, and receive monthly email feedback. Participants in Small Changes are taught to make small daily changes (~100 calorie changes) in how much or what they eat and to accumulate 2000 additional steps per day. Participants in Large Changes are taught to create a weight loss buffer of 5–10 pounds once per year to protect against anticipated weight gains. Both groups are encouraged to self-weigh daily and taught a self-regulation color zone system that specifies action depending on weight gain prevention success. Individualized treatment contact is offered to participants who report weight gains. Participants are assessed at baseline, 4 months, and then annually. The primary outcome is weight gain over an average of 3 years of follow-up; secondary outcomes include diet and physical activity behaviors, psychosocial measures, and cardiovascular disease risk factors. Discussion SNAP is unique in its focus on weight gain prevention in young adulthood. The trial will provide important information about whether either or both of these novel interventions are effective in preventing weight gain. Trial registration ClinicalTrials.gov, NCT01183689