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Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were −3·26 kg (brief intervention), −4·75 kg (12-week programme), and −6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference −2·71 kg, 95% CI −3·86 to −1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (−2·14 kg, −3·05 to −1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

Objectives. We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention. Methods. Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons. Results. In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone. Conclusions. The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.

About 75 % of African-Americans (AAs) ages 20 or older are overweight and nearly 50 % are obese, but community-based programs to reduce diabetes risk in AAs are rare. Our objective was to reduce weight and fasting plasma glucose (FPG) and increase physical activity (PA) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul (FBAS). We conducted a single-blinded, cluster randomized, community trial in 20 AA churches enrolling 604 AAs, aged 20–64 years with BMI C 25 kg/m 2 and without diabetes. The church (and their parishioners) was randomized to FBAS or health education (HE). FBAS participants had a significant difference in adjusted weight loss compared with those in HE (2.62 vs. 0.50 kg, p = 0.001) at 12-weeks and (2.39 vs.-0.465 kg, p = 0.005) at 12-months and were more likely (13 %) than HE participants (3 %) to achieve a 7 % weight loss (p < 0.001) at 12-weeks and a 7 % weight loss (19 vs. 8 %, p < 0.001) at 12-months. There were no significant differences in FPG and PA between arms. Of the 15.2 % of participants with baseline pre-diabetes, those in FBAS had, however, a significant decline in FPG (10.93 mg/dl) at 12-weeks compared with the 4.22 mg/dl increase in HE (p = 0.017), and these differences became larger at 12-months (FBAS, 12.38 mg/dl decrease; HE, 4.44 mg/dl increase) (p = 0.021). Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants. ClinicalTrials. gov Identifier NCT01730196.

Background: Hispanic children and men carry a high burden for obesity and associated medical conditions. Healthy Dads Healthy Kids was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia. The aim of this study was to assess the feasibility of a culturally adapted version of the program for Hispanic families, Papás Saludables Niños Saludables. Methods: A randomized waitlist controlled trial with a process evaluation was conducted to assess the feasibility of Papás Saludables Niños Saludables (NCT03532048). Fathers, their partner (mother), and one to three children were enrolled. A priori feasibility criteria were: (1) recruit 40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4) obtain 80% “excellent” or “good” satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up. Results: The study enrolled 90% (n = 36) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% “excellent/good” satisfaction ratings among the participating fathers and mothers. One hundred percent of participants had most anthropometric and behavioral data at baseline and 72% at follow-up. Conclusions: With oversampling and improvements in the recruitment strategies, Papás Saludables Niños Saludables is feasible for a randomized controlled clinical trial to address whether a father-targeted lifestyle program is efficacious among low-income Hispanic men and their children.

Background Describing how and why an evidence-based intervention is adapted for a new population and setting using a formal evaluation and an adaptation framework can inform others seeking to modify evidence-based weight management interventions for different populations or settings. The Working for You intervention was adapted, to fit a workplace environment, from Be Fit Be Well, an evidence-based intervention that targets weight-control and hypertension in patients at an outpatient clinic. Workplace-based efforts that promote diet and activity behavior change among low-income employees have potential to address the obesity epidemic. This paper aims to explicitly describe how Be Fit Be Well was adapted for this new setting and population. Methods To describe and understand the worksite culture, environment, and policies that support or constrain healthy eating and activity in the target population, we used qualitative and quantitative methods including key informant interviews, focus groups, and a worker survey; these data informed intervention adaptation. We organized the adaptations made to Be Fit Be Well using an adaptation framework from implementation science. Results The adapted intervention, Working for You, maintains the theoretical premise and evidence-base underpinning Be Fit Be Well. However, it was modified in terms of the means of delivery (i.e., rather than using interactive voice response, Working for You employs automated SMS text messaging), defined as a modification to context by the adaptation framework. The adaptation framework also includes modifications to content; in this case the behavioral goals were modified for the target population based on updated science related to weight loss and to target a workplace population (e.g., a goal to avoiding free food at work). Conclusions If effective, this scalable and relatively inexpensive intervention can be translated to other work settings to reduce obesity and diabetes risk among low-SES workers, a group with a higher prevalence of these conditions. Using a formal evaluation and framework to guide and organize how and why an evidence-based intervention is adapted for a new population and setting can push the field of intervention research forward. Trial registration ClinicalTrials.gov: NCT02934113 ; Received: October 12, 2016; Updated: November 7, 2017.

Background The health outcomes of men continue to be poorer than women globally. Challenges in addressing this problem include difficulties engaging men in weight loss programs as they tend to view these programs as contrary to the masculine narrative of independence and self-reliance. Researchers have been turning towards sports fans to engage men in health promotion programs as sports fans are typically male, and tend to have poor health habits. Methods Developed from the highly successful gender-sensitized Football Fans in Training program, Hockey Fans in Training (Hockey FIT) recruited 80 male hockey fans of the London Knights and Sarnia Sting who were overweight or obese into a weekly, 90-minute classroom education and group exercise program held over 12 weeks; a 40-week minimally-supported phase followed. A process evaluation of the Hockey FIT program was completed alongside a pragmatic randomized controlled trial and outcome evaluation in order to fully explore the acceptability of the Hockey FIT program from the perspectives of coaches delivering and participants engaged in the program. Data sources included attendance records, participant focus groups, coach interviews, assessment of fidelity (program observations and post-session coach reflections), and 12-month participant interviews. Results Coaches enjoyed delivering the program and found it simple to deliver. Men valued being among others of similar body shape and similar weight loss goals, and found the knowledge they gained through the program helped them to make and maintain health behaviour changes. Suggested improvements include having more hockey-related information and activities, greater flexibility with timing of program delivery, and greater promotion of technology support tools. Conclusions We confirmed Hockey FIT was an acceptable “gender-sensitized” health promotion program for male hockey fans who were overweight or obese. Minor changes were required for optimization, which will be evaluated in a future definitive trial. Trial registration NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.

Background PEACH™QLD translated the PEACH™ Program, designed to manage overweight/obesity in primary school-aged children, from efficacious RCT and small scale community trial to a larger state-wide program. This paper describes the lessons learnt when upscaling to universal health coverage. Methods The 6-month, family-focussed program was delivered in Queensland, Australia from 2013 to 2016. Its implementation was planned by researchers who developed the program and conducted the RCT, and experienced project managers and practitioners across the health continuum. The intervention targeted parents as the agents of change and was delivered via parent-only group sessions. Concurrently, children attended fun, non-competitive activity sessions. Sessions were delivered by facilitators who received standardised training and were employed by a range of service providers. Participants were referred by health professionals or self-referred in response to extensive promotion and marketing. A pilot phase and a quality improvement framework were planned to respond to emerging challenges. Results Implementation challenges included engagement of the health system; participant recruitment; and engagement. A total of 1513 children (1216 families) enrolled, with 1122 children (919 families) in the face-to-face program (105 groups in 50 unique venues) and 391 children (297 families) in PEACH™ Online. Self-referral generated 68% of enrolments. Unexpected, concurrent and, far-reaching public health system changes contributed to poor program uptake by the sector (only 56 [53%] groups delivered by publicly-funded health organisations) requiring substantial modification of the original implementation plan. Process evaluation during the pilot phase and an ongoing quality improvement framework informed program adaptations that included changing from fortnightly to weekly sessions aligned with school terms, revision of parent materials, modification of eligibility criteria to include healthy weight children and provision of services privately. Comparisons between pilot versus state-wide waves showed comparable prevalence of families not attending any sessions (25% vs 28%) but improved number of sessions attended (median = 5 vs 7) and completion rates (43% vs 56%). Conclusions Translating programs developed in the research context to enable implementation at scale is complex and presents substantial challenges. Planning must ensure there is flexibility to accommodate and proactively manage the system changes that are inevitable over time. Trial registration ACTRN12617000315314 . This trial was registered retrospectively on 28 February, 2017.

ABSTRACT BACKGROUND Despite U.S. Preventive Services Task Force recommendations, few primary care providers (PCPs) counsel obese patients about weight loss. The POWER practice-based weight loss trial used health coaches to provide weight loss counseling, but PCPs referred their patients and reviewed their patients’ progress reports. This trial provided a unique opportunity to understand PCPs’ actual and desired roles in a multi-component weight loss intervention. OBJECTIVE 1) To explore the PCP role, inclusive of and beyond the trial’s intended role, in a practice-based weight loss trial; and 2) to elicit recommendations by PCPs for wider dissemination of the successful multi-component program. DESIGN Qualitative focus group study of PCPs with ≥ 4 patients enrolled in trial. PARTICIPANTS Twenty-six out of 30 PCPs from six community practices participated between June and August 2010. MAIN MEASURES We used a semi-structured moderator guide. Focus groups were audio-recorded and transcribed verbatim. Two investigators independently coded transcripts for thematic content, identified meaningful segments within the responses and assigned codes using an editing style analysis. Atlas.ti software was used for organization/analysis. MAIN RESULTS We identified five major themes related to the PCP’s role in patients’ weight management: (1) refer patients into program, provide endorsement; (2) provide accountability for patients; (3) “cheerlead” for patients during visits; (4) have limited role in weight management; and (5) maintain the long-term trusting relationship through the ups and downs. PCPs provided several recommendations for wider dissemination of the program into primary care practices, highlighting the need for specific feedback from coaches as well as efficient, integrated processes. CONCLUSIONS Weight loss programs have the potential to partner with PCPs to build upon the patient–provider relationship to improve patient accountability and sustain behavior change. However, rather than directing the weight loss, PCPs preferred a peripheral role by utilizing health coaches.

Preventing weight regain after the loss of excess weight is challenging for people, especially for ethnic minorities in the United States. A 6-month weight loss maintenance intervention designed for Pacific Islanders, called the PILI Lifestyle Program (PLP), was compared with a 6-month standard behavioral weight loss maintenance program (SBP) in a pilot randomized controlled trial using a community-based participatory research approach. Adult Pacific Islanders (N = 144) were randomly assigned to either PLP (n = 72) or SBP (n = 72) after completing a 3-month weight loss program. Successful weight maintenance was defined as participants' postintervention weight change remaining ≤3% of their preintervention mean weight. Both PLP and SBP participants achieved significant weight loss maintenance (p ≤ .05). Among participants who completed at least half of the prescribed sessions, PLP participants were 5.1-fold (95% confidence interval = 1.06, 24; p = .02) more likely to have maintained their initial weight loss than SBP participants. The pilot PLP shows promise as a lifestyle intervention to address the obesity disparities of Pacific Islanders and thus warrants further investigation.

Background Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale. Methods The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016. Results Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project. Conclusions Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature.