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Background: Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest., Methods: We proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial., Results: A total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m 2 , 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001., Conclusion: Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The research described in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, under award number R01DK119244., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Competing Interests: The authors have no disclosures or conflicts of interest.

Background: Rural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention., Objective: This analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas., Design: A cost-utility analysis was conducted., Participants/setting: Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy., Intervention: Trial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status., Main Outcome Measures: T2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator., Statistical Analyses Performed: Using a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation., Results: All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored., Conclusions: Because most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults., (Copyright © 2020 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Obesity is a major contributor to the greater prevalence of chronic disease morbidity and mortality observed in rural versus nonrural areas of the U.S. Nonetheless, little research attention has been given to modifying this important driver of rural/urban disparities in health outcomes. Although lifestyle treatments produce weight reductions of sufficient magnitude to improve health, the existing research is limited with respect to the long-term maintenance of treatment effects and the dissemination of services to underserved populations. Recent studies have demonstrated the feasibility of delivering lifestyle programs through the infrastructure of the U.S. Cooperative Extension Service (CES), which has >2900 offices nationwide and whose mission includes nutrition education and health promotion. In addition, several randomized trials have shown that supplementing lifestyle treatment with extended-care programs consisting of either face-to-face sessions or individual telephone counseling can improve the maintenance of weight loss. However, both options entail relatively high costs that inhibit adoption in rural communities. The delivery of extended care via group-based telephone intervention may represent a promising, cost-effective alternative that is well suited to rural residents who tend to be isolated, have heightened concerns about privacy, and report lower quality of life. The Rural Lifestyle Eating and Activity Program (Rural LEAP) is a randomized trial, conducted via CES offices in rural communities, targeted to adults with obesity (n = 528), and designed to evaluate the effectiveness and cost-effectiveness of extended-care programs delivered via group or individual telephone counseling compared to an education control condition on long-term changes in body weight., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Obesity disproportionately affects rural residents in the United States, and primary care has the potential to fill a major gap in the provision of weight management services for rural communities. The objective of this cluster-randomized pragmatic trial is to evaluate the comparative effectiveness of three obesity treatment models in rural primary care: the Intensive Behavior Therapy fee-for-service (FFS) model reimbursed by Medicare, a team-based model that recognizes the patient-centered medical home (PCMH) as a preferred delivery approach, and the centralized disease management (DM) model, in which phone-based counseling is provided outside of the primary care practice. We hypothesize that the PCMH and DM treatments will be more effective than FFS in reducing weight at 24 months. Thirty-six practices from the rural Midwestern U.S. are randomized to deliver one of the three interventions to 40 patients (N=1440) age 20 to 75 with a BMI 30-45 kg/m(2). In the FFS arm, primary care providers and their personnel counsel patients to follow evidence-based weight loss guidelines using the Medicare-designated treatment schedule. In the PCMH arm, patients receive a comprehensive weight management intervention delivered locally by practice personnel using a combination of in-person and phone-based group sessions. In the DM arm, the same intervention is delivered remotely by obesity treatment specialists via group conference calls. The primary outcome is weight loss at 24 months. Additional measures include fasting glucose, lipids, quality of life indicators, and implementation process measures. Findings will illuminate effective obesity treatment intervention(s) in rural primary care., (Copyright © 2016. Published by Elsevier Inc.)

Background: Reducing consumption of food away from home is often targeted during pediatric obesity treatment, given the associations with weight status and gain. However, the effects of this dietary change on weight loss are unknown., Objective: Our aim was to evaluate associations between changes in dietary factors and child anthropometric outcomes after treatment. It is hypothesized that reduced consumption of food away from home will be associated with improved dietary intake and greater reductions in anthropometric outcomes (standardized body mass index [BMI] and percent body fat), and the relationship between food away from home and anthropometric outcomes will be mediated by improved child dietary intake., Design: We conducted a longitudinal evaluation of associations between dietary changes and child anthropometric outcomes. Child diet (three 24-hour recalls) and anthropometric data were collected at baseline and 16 weeks., Participants/setting: Participants were 170 overweight and obese children ages 7 to 11 years who completed a 16-week family-based behavioral weight-loss treatment as part of a larger multi-site randomized controlled trial conducted in two cohorts between 2010 and 2011 (clinical research trial)., Intervention: Dietary treatment targets during family-based behavioral weight-loss treatment included improving diet quality and reducing food away from home., Main Outcome Measures: The main outcome measures in this study were child relative weight (standardized BMI) and body composition (percent body fat)., Statistical Analyses: We performed t tests and bootstrapped single-mediation analyses adjusting for relevant covariates., Results: As hypothesized, decreased food away from home was associated with improved diet quality and greater reductions in standardized BMI (P<0.05) and percent body fat (P<0.01). Associations between food away from home and anthropometric outcomes were mediated by changes in diet quality. Specifically, change in total energy intake and added sugars mediated the association between change in food away from home and standardized BMI, and change in overall diet quality, fiber, added sugars, and added fats mediated the association between change in food away from home and percent body fat. Including physical activity as a covariate did not significantly impact these findings., Conclusions: These results suggest that reducing food away from home can be an important behavioral target for affecting positive changes in both diet quality and anthropometric outcomes during treatment., (Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: A major challenge after successful weight loss is continuing the behaviors required for long-term weight maintenance. This challenge can be exacerbated in rural areas with limited local support resources., Objective: This study describes and compares program costs and cost effectiveness for 12-month extended-care lifestyle maintenance programs after an initial 6-month weight-loss program., Design: We conducted a 1-year prospective randomized controlled clinical trial., Participants/setting: The study included 215 female participants age 50 years or older from rural areas who completed an initial 6-month lifestyle program for weight loss. The study was conducted from June 1, 2003 to May 31, 2007., Intervention: The intervention was delivered through local Cooperative Extension Service offices in rural Florida. Participants were randomly assigned to a 12-month extended-care program using either individual telephone counseling (n=67), group face-to-face counseling (n=74), or a mail/control group (n=74)., Main Outcome Measures: Program delivery costs, weight loss, and self-reported health status were directly assessed through questionnaires and program activity logs. Costs were estimated across a range of enrollment sizes to allow inferences beyond the study sample., Statistical Analyses Performed: Nonparametric and parametric tests of differences across groups for program outcomes were combined with direct program cost estimates and expected value calculations to determine which scales of operation favored alternative formats for lifestyle maintenance., Results: Median weight regain during the intervention year was 1.7 kg for participants in the face-to-face format, 2.1 kg for the telephone format, and 3.1 kg for the mail/control format. For a typical group size of 13 participants, the face-to-face format had higher fixed costs, which translated into higher overall program costs ($420 per participant) when compared with individual telephone counseling ($268 per participant) and control ($226 per participant) programs. Although the net weight lost after the 12-month maintenance program was higher for the face-to-face and telephone programs compared with the control group, the average cost per expected kilogram of weight lost was higher for the face-to-face program ($47/kg) compared with the other two programs (approximately $33/kg for telephone and control)., Conclusions: Both the scale of operations and local demand for programs are important considerations in selecting a delivery format for lifestyle maintenance. In this study, the telephone format had a lower cost but similar outcomes compared with the face-to-face format., (Copyright © 2012 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) is a three-arm, randomized controlled trial assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population, overweight and obese children and their parents in rural counties. Participants will include 240 parent-child dyads from nine rural counties in north central Florida. Dyads will be randomized to one of three conditions: (a) a Family-Based Behavioral Group Intervention, (b) a Parent-Only Behavioral Group Intervention, and (c) an Education Control Condition. Child and parent participants will be assessed at baseline (month 0), post-treatment (month 12) and follow-up (month 24). Assessment and intervention sessions will be held at Cooperative Extension Service offices within each participating county. The primary outcome measure is change in child BMI z-score. Additional key outcome measures include child body fat, waist circumference, dietary intake, physical activity, blood lipids, blood glucose, blood pressure, physical fitness, quality of life, and program and participants costs. Parent BMI, dietary intake, and physical activity also will be assessed. Randomized controlled trials testing the effectiveness of childhood obesity interventions in real-world community-based settings are extremely valuable, but much too rare. The E-FLIP for Kids trial will evaluate the impact of a community-based intervention delivered to families in rural settings utilizing the existing Cooperative Extension Service network on long-term child behavior, weight status and biological markers of diabetes and early cardiovascular disease. If successful, a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Project STORY is a 3-arm, randomized, planning and feasibility study assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population, overweight children and their parents in medically underserved rural counties. Participants will include 90 parent-child dyads from rural counties in north central Florida. Families will be randomized to one of three conditions: (a) a Family-Based Behavioral Group Intervention, (b) a Parent-Only Behavioral Group Intervention, and (c) a waitlist control condition. Child and parent participants will be assessed at baseline (month 0), post-treatment (month 4) and follow-up (month 10). Assessment and intervention sessions will be held at Cooperative Extension offices within each local participating county. The primary outcome measure is change in child body mass index (BMI) z-score. Additional key outcome measures include child dietary intake, physical activity, self-esteem, body image, and parent BMI. The goals of the study are to (a) assess the feasibility of recruitment in rural settings, (b) develop and evaluate training protocol for group leaders, (c) determine strategies to increase adherence to monitoring and goal setting protocol, (d) evaluate strategies for participant retention, (e) assess the relative cost-effectiveness of the interventions, (f) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel, and (g) if successful, estimate the sample size needed for a full-scale trial. This research has potential implications for medically underserved rural communities with limited resources and preventive health care services. If successful, a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities.

Objective: To identify predictors of dietary change to and maintenance of a low-fat eating pattern (<20% energy from fat, > or = 5 servings fruits/vegetables daily, and > or = 6 servings grains daily) among a cohort of postmenopausal women. Candidate predictors included intrapersonal, interpersonal, intervention program characteristics, and clinical center., Design: Longitudinal study within the Women's Health Initiative Dietary Modification Trial. Dietary change was evaluated after 1 year of participation in the Women's Health Initiative Dietary Modification Trial, and dietary maintenance after 3 years., Subjects: Postmenopausal women aged 50 to 79 years at baseline who were randomized to the intervention arm of the Women's Health Initiative Dietary Modification Trial (n=19,541)., Statistical Analysis: Univariate and multivariate linear regression analysis was performed and associations evaluated between candidate predictors and each of the three dietary goals: percent energy from fat, fruit/vegetable servings, and grain servings., Results: Year 1 (change) predictors of percent energy from fat (P<0.005) included being younger (beta=2.12; 70 to 79 years vs 50 to 59 years), more educated (beta=-.69; college vs high school), more optimistic (beta=-.07), attending more sessions (beta=-.69), and submitting more self-monitoring records (beta=-.74). At year 3 (maintenance), the predictors of percent energy from fat (P<0.005) included attending more sessions (beta=-.65) and submitting more self-monitoring scores (beta=-.71). The analytic model predicted 22% of the variance in fat intake at year 1 and 27% at year 3 (P<0.01)., Conclusions: The strongest predictors of dietary change and maintenance were attending intervention sessions and self-monitoring dietary intake. Novel was the finding that optimism predicted dietary change.

Objective: To examine whether the effects of physical and emotional status on adherance to a low-fat (20% energy) dietary pattern are mediated by participation in an intervention program (attending sessions and self-monitoring)., Design: The Baron and Kenny mediator model, a series of 4 regression analyses, was used to evaluate whether: a) physical and emotional status predicted program participation, b) program participation predicted dietary adherence, c) physical and emotional status factors predicted dietary adherence, and, ultimately d) the effects of physical and emotional status on dietary adherence were mediated by program participation., Subjects/setting: Data from 13,277 postmenopausal women randomly assigned to the low-fat intervention arm of the Women's Health Initiative Dietary Modification Trial., Intervention: The nutrition goals for women randomly assigned to the low-fat intervention were to reduce total fat intake to 20% or less of energy from fat and to consume 5 or more fruit/vegetable servings daily and 6 or more grain servings daily., Main Outcome Measures: Year 1 program participation (degree of attending group sessions and submitting fat scores) and adherence to the low-fat dietary pattern (percent energy from fat) as predicted by baseline physical and emotional status (eight SF-36 Health Survey subscales)., Results: Participating in the dietary intervention program reduced (mediated) the negative effect of poorer mental health on dietary adherence by 15%. Additional findings included that a 10% increase in physical functioning increased session attendance by 0.4% (P<.001) and a 10% increase in mental health predicted a decrease in percent energy from fat of 0.3% (P<.001). Program participation had a marked effect on dietary adherence: a 10% increase in session attendance predicted a 1.2% decrease in percent energy from fat (P<.001)., Applications/conclusions: Understanding and using instruments to assess the physical and emotional status of a target population will help dietetic professionals promote healthful dietary change and maintenance.

Study Objectives: The purpose of this study was to determine the impact of a pretransplantation determination of body mass index (BMI) on survival after lung transplantation., Design and Patients: Univariate and multivariate survival analyses of a single institution database consisting of 85 patients who had undergone lung transplantations between March 1994 and October 1998., Setting: University of Florida Health Science Center., Results: Kaplan-Meier survival curves showed that patients who were obese (ie, BMI, > or = 30) at a pretransplantation assessment had a marked decrease in posttransplantation survival time (log rank, p < 0.05; Wilcoxon, p < 0.05). The final Cox regression model revealed that the most powerful predictors of mortality after lung transplantation were higher pretransplantation BMI and the development of obliterative bronchiolitis., Conclusions: Our results suggest that the posttransplantation risk for mortality is possibly three times greater for obese patients than for nonobese patients. Additional study is needed to identify the mechanisms for such higher risk in obese patients. Our data also suggest that transplantation centers should not routinely reject underweight patients (ie, BMI, < 18.5) or overweight patients (ie, BMI, 25 to 29.9) for lung transplantation listing solely on the basis of weight, as their outcomes may not be significantly different than patients with normal BMIs.

Adherence determinants and key adherence research issues are discussed for three types of randomized controlled trials: pharmacological, dietary, and physical activity. This article highlights theoretical and methodological limitations that have hampered the ability to identify patients at risk for poor treatment compliance. Control Clin Trials 2000;21:195S-199S

This paper reviews issues regarding dietary adherence. Issues and barriers unique to dietary adherence, in contrast to adherence to physical activity or medication regimens, are discussed. These include decision making, social and cultural contexts, perceptions and preferences, and environmental barriers. We review factors known to increase adherence in dietary interventions, including education, motivation, behavioral skills, new and modified foods, and supportive interactions. We conclude with directions for future study, such as improved measurement of diet-related behavior and longitudinal, culturally sensitive interventions. Control Clin Trials 2000;21:206S-211S

In this study, the authors describe the psychological characteristics of a large sample (N = 407) of adult patients evaluated for liver transplantation, and provide normative data on commonly used measures of cognitive functioning, affective status, psychosocial adjustment, coping, quality of life, and life satisfaction. The normative data suggest that the study's liver transplant candidates have poorer cognitive functioning and health-related quality of life when compared with available normative comparison groups, yet the former group is more comparable to medically ill peers on measures of anxiety, depression, psychosocial adjustment, and coping. Data also suggest a high rate of affective disturbance in liver transplant candidates. Results indicate the utility of normative data, such as the authors', for providing an appropriate comparison group for liver pretransplant candidates.

Objective: We sought to find a combination of noninvasive treatments for snoring by adding weight loss to previously studied treatments, including the combination of sleeping on one's side and using a decongestant nasal spray., Study Population: Twenty asymptomatic men who snore heavily were studied previously on a control night and on a night when they slept on their side and used a nasal spray. With these two treatments, minor improvements in apnea/hypopnea index (AHI) were seen, but no improvement occurred in snoring frequency. Nineteen of these subjects subsequently completed a 6-month weight loss program, and 12 lost weight. These 19 subjects comprise the study population of this report., Study Design: At the conclusion of the weight loss program, a repeated sleep study was done from which the effect of adding weight loss to the two previously studied treatments could be assessed., Results: Those 12 subjects who lost any amount of weight showed a very mild reduction in snores per hour from 328 using two modalities of treatment to 232 per hour with the addition of weight loss (p = 0.15). The nine subjects who lost > or = 3 kg reduced the number of snores per hour from 320 to 176 (p = 0.0496). Three subjects losing an average of only 7.6 kg showed virtual elimination of snoring after weight loss. Subjects who gained weight had no improvement in snoring. Weight loss added to the other two modalities of treatment had no effect on the AHI., Conclusion: In most cases, the combination of weight loss, sleeping on one's side, and the administration of a nasal decongestant significantly reduces the frequency of snoring in asymptomatic men who snore heavily. The major effect appears to be related to weight loss.