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Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

ABSTRACT: 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.

SUBMITTER: Befort CA

PROVIDER: S-EPMC3992482 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

Befort Christie A CA Klemp Jennifer R JR Fabian Carol C Perri Michael G MG Sullivan Debra K DK Schmitz Kathryn H KH Diaz Francisco J FJ Shireman Theresa T

Contemporary clinical trials 20140131 2

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 individua ...[more]

PMID: 24486636

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Project description:Despite high obesity prevalence rates, few low-income midlife women participate in weight loss maintenance trials. This pilot study aims to assess the effectiveness of two weight loss maintenance interventions in this under-represented population.Low-income midlife women who completed a 16-week weight loss intervention and lost ???8 lbs (3.6 kg) were eligible to enroll in one of two 12-month maintenance programs. The programs were similar in content and had the same number of total contacts, but were different in the contact modality (Phone?+?Face-to-Face vs. Face-to-Face Only). Two criteria were used to assess successful weight loss maintenance at 12 months: (1) retaining a loss of? ??5% of body weight from the start of the weight loss phase and (2) a change in body weight of? <?3%, from the start to the end of the maintenance program. Outcome measures of changes in physiologic and psychosocial factors, and evaluations of process measures and program acceptability (measured at 12 months) are also reported. For categorical variables, likelihood ratio or Fisher's Exact (for small samples) tests were used to evaluate statistically significant relationships; for continuous variables, t-tests or their equivalents were used to assess differences between means and also to identify correlates of weight loss maintenance.Overall, during the 12-month maintenance period, 41% (24/58) of participants maintained a loss of ???5% of initial weight and 43% (25/58) had a <3% change in weight. None of the comparisons between the two maintenance programs were statistically significant. However, improvements in blood pressure and dietary behaviors remained significant at the end of the 12-month maintenance period for participants in both programs. Participant attendance and acceptability were high for both programs.The effectiveness of two pilot 12-month maintenance interventions provides support for further research in weight loss maintenance among high-risk, low-income women.ClinicalTrials.gov Identifier: NCT00288301.

Project description:BackgroundThe World Health Organization (WHO) estimates that the number of obese or overweight individuals worldwide will increase to 1.5 billion by 2015. Chronic diseases associated with overweight or obesity include diabetes, heart disease, hypertension and stroke.ObjectivesTo assess the effects of interactive computer-based interventions for weight loss or weight maintenance in overweight or obese people.Search methodsWe searched several electronic databases, including CENTRAL, MEDLINE, EMBASE, CINAHL, LILACS and PsycINFO, through 25 May 2011. We also searched clinical trials registries to identify studies. We scanned reference lists of included studies and relevant systematic reviews.Selection criteriaStudies were included if they were randomized controlled trials or quasi-randomized controlled trials that evaluated interactive computer-based weight loss or weight maintenance programs in adults with overweight or obesity. We excluded trials if the duration of the intervention was less than four weeks or the loss to follow-up was greater than 20% overall.Data collection and analysisTwo authors independently extracted study data and assessed risk of bias. Where interventions, control conditions, outcomes and time frames were similar between studies, we combined study data using meta-analysis.Main resultsWe included 14 weight loss studies with a total of 2537 participants, and four weight maintenance studies with a total of 1603 participants. Treatment duration was between four weeks and 30 months. At six months, computer-based interventions led to greater weight loss than minimal interventions (mean difference (MD) -1.5 kg; 95% confidence interval (CI) -2.1 to -0.9; two trials) but less weight loss than in-person treatment (MD 2.1 kg; 95% CI 0.8 to 3.4; one trial). At six months, computer-based interventions were superior to a minimal control intervention in limiting weight regain (MD -0.7 kg; 95% CI -1.2 to -0.2; two trials), but not superior to infrequent in-person treatment (MD 0.5 kg; 95% -0.5 to 1.6; two trials). We did not observe consistent differences in dietary or physical activity behaviors between intervention and control groups in either weight loss or weight maintenance trials. Three weight loss studies estimated the costs of computer-based interventions compared to usual care, however two of the studies were 11 and 28 years old, and recent advances in technology render these estimates unlikely to be applicable to current or future interventions, while the third study was conducted in active duty military personnel, and it is unclear whether the costs are relevant to other settings. One weight loss study reported the cost-effectiveness ratio for a weekly in-person weight loss intervention relative to a computer-based intervention as USD 7177 (EUR 5678) per life year gained (80% CI USD 3055 to USD 60,291 (EUR 2417 to EUR 47,702)). It is unclear whether this could be extrapolated to other studies. No data were identified on adverse events, morbidity, complications or health-related quality of life.Authors' conclusionsCompared to no intervention or minimal interventions (pamphlets, usual care), interactive computer-based interventions are an effective intervention for weight loss and weight maintenance. Compared to in-person interventions, interactive computer-based interventions result in smaller weight losses and lower levels of weight maintenance. The amount of additional weight loss, however, is relatively small and of brief duration, making the clinical significance of these differences unclear.

Project description:BACKGROUND:Few people successfully maintain lost weight over the longer term. Mobile phones have the potential to deliver weight loss management programs that can encourage self-monitoring while also providing some behavioral therapy to assist users in developing personal skills that may be necessary for improved longer term weight loss maintenance. OBJECTIVE:The aim of this study was to evaluate a program supporting weight maintenance, which uses a behaviorally based mobile phone app to manage weight, food, exercise, mood, and stress. METHODS:In a randomized controlled trial over 24 weeks, the full version of the app (MotiMate) was compared with a control app (monitoring only; excluding mood and stress) for its effect on weight, diet, and psychological well-being. Both apps had the same visual appearance and were designed to deliver all intervention content without face-to-face contact. The control version included features to track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features. The intervention app included more persuasive and interactive features to help users track their weight, food intake, and physical activity and prompted users to enter data each day through notifications and included a mood and stress workshopping tool. Participants were recruited through advertising and existing databases. Clinic visits occurred at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. At all visits, the clinical trial manager recorded body weight, and participants then completed a computer-delivered survey, which measured psychological and lifestyle outcomes. Objective app usage data were recorded throughout the trial. RESULTS:A total of 88 adults who had lost and maintained at least 5% of their body weight within the last 2 years were randomized (45 MotiMate and 43 control). Overall, 75% (66/88) were female, and 69% (61/88) completed week 24 with no differences in dropout by condition (χ21,87=0.7, P=.49). Mixed models suggested no significant changes in weight or psychological outcomes over 24 weeks regardless of condition. Of 61 completers, 53% (32/61) remained within 2% of their starting weight. Significant increases occurred over 24 weeks for satisfaction with life and weight loss self-efficacy regardless of app condition. Diet and physical activity behaviors did not vary by app or week. Negative binomial models indicated that those receiving the full app remained active users of the app for 46 days longer than controls (P=.02). Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). CONCLUSIONS:Although some aspects of the intervention app such as usage and user feedback showed promise, there were few observable effects on behavioral and psychological outcomes. Future evaluation of the app should implement alternative research methods or target more specific populations to better understand the utility of the coping interface. TRIAL REGISTRATION:Australia New Zealand Clinical Trials Registry ACTRN12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120.

Dataset Information

Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

Publications

Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

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