Abstract
BackgroundWeight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women. Finding effective interventions using innovative delivery methods that can reach underserved and vulnerable populations of overweight and obese rural women is a public health challenge.Methods/DesignThis Women Weigh-In for Wellness (The WWW study) randomized-controlled trial is designed to compare the effectiveness of theory-based behavior-change interventions using (1) website only, (2) website with peer-led support, or (3) website with professional email-counseling to facilitate initial weight loss (baseline to 6 months), guided continuing weight loss and maintenance (7-18 months) and self-directed weight maintenance (19-30 months) among rural women ages 45-69 with a BMI of 28-45. Recruitment efforts using local media will target 306 rural women who live within driving distance of a community college site where assessments will be conducted at baseline, 3, 6, 12, 18, 24 and 30 months by research nurses blinded to group assignments. Primary outcomes include changes in body weight, % weight loss, and eating and activity behavioral and biomarkers from baseline to each subsequent assessment. Secondary outcomes will be percentage of women achieving at least 5% and 10% weight loss without regain from baseline to 6, 18, and 30 months and achieving healthy eating and activity targets. Data analysis will use generalized estimating equations to analyze average change across groups and group differences in proportion of participants achieving target weight loss levels.DiscussionThe Women Weigh-In for Wellness study compares innovative web-based alternatives for providing lifestyle behavior-change interventions for promoting weight loss and weight maintenance among rural women. If effective, such interventions would offer potential for reducing overweight and obesity among a vulnerable, hard-to-reach, population of rural women.Trial RegistrationClinicalTrials.gov: NCT01307644
Highlights
Weight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women
This paper describes the protocol for a randomized controlled trial that aims to promote healthy eating and activity in order to achieve a targeted weight loss of 5% to 10% and weight maintenance among rural women ages 45-69 with a body mass index (BMI) of 28-45
Secondary outcomes will be the percentage of women achieving at least 5% and 10% weight loss from baseline without regain, as well as achieving healthy eating and activity criterion standards at time points that correspond with the intervention phases (6, 18, 30 months)
Summary
Providing an effective intervention for behavior-change to promote weight loss and weight maintenance among midlife and older rural women is needed, as these women have a high prevalence of overweight and obesity. These theory-based web-delivery interventions offer innovative approaches to offer weight loss and maintenance counseling to this hard-to-reach vulnerable group of rural women. This research will implement a distance model for delivery of lifestyle modification and information to provide accessible lifestyle guidance to a hard-to-reach clientele If effective, these interventions may provide benefit to over-worked and under-reimbursed rural providers who may not have the time to deliver lifestyle modification programs. If any of the interventions are found effective, follow up testing for pre-packaged programs for the public offered through settings such as public health departments, primary care offices, or health education settings may be appropriate
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