The Weight-Wise Weight Loss Translation Study
Condition: Overweight; Obesity; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      The overall goal of the translational research is to evaluate the processes and outcomes of
      implementing, in a range of public health agencies, an intense, evidence-based behavioral
      weight loss intervention with demonstrated effectiveness among midlife low-income women. The
      intervention was originally studied in a single coordinated community health care
      center/church setting and delivered by research staff. The investigators will evaluate the
      intervention's translation and test its effectiveness as implemented by existing staff in six
      public health agencies supported by local community resources.
    

Detailed description: 
      Low-income women in the US have the highest rates of overweight and obesity, putting them at
      increased risk for diabetes, heart disease, and other chronic illnesses. Because mean body
      mass index gradually increases during adult life and peaks at 50-59 years of age, low income
      women between 40-64 years are a group deserving of special attention. While there is
      sufficient evidence that some behavioral weight management interventions are effective in
      producing clinically meaningful levels of weight loss with reductions in cardiovascular risk
      factors and delayed onset of diabetes, there is a research gap in translating these
      efficacious interventions to real life settings and diverse population groups. Research that
      seeks to translate effective behavioral weight management interventions from
      resource-intensive efficacy trials to long-term adoption and implementation by public health
      settings serving a diverse low-income population is timely and of great public health
      significance. This translational research can provide important information to
      decision-makers about evidence-based intervention delivery, resource allocation, and
      workforce preparation.

      The overall goal of the proposed research is to evaluate the processes and outcomes of
      translating from research to practice an intense, evidence-based behavioral weight loss
      intervention with demonstrated effectiveness among midlife low-income women. Originally
      studied in a single coordinated community health care center/church setting and delivered by
      research staff (Weight-Wise Pilot Study), we will evaluate the translation of and test the
      effectiveness of this intervention as implemented by existing staff in a range of county
      health departments supported by local community resources.

      To evaluate the translation process, we will use the RE-AIM framework, diffusion of
      innovation theory, and systematic models of adaptation to assess: 1) factors related to
      reach; contextual or setting-specific factors necessary for successful adoption and
      implementation; 2) effectiveness of facilitator training and stakeholder collaborations; 3)
      adaptation and fidelity during implementation; and 4) costs associated with the
      implementation and outcomes. To test the intervention's effectiveness, we will enroll 240
      overweight or obese low-income women, 40-64 years of age, at 6 representative public health
      agencies. Participants will be randomized to receive a 16-week behavioral weight loss
      intervention (special intervention group) or usual care (wait listed control group). The
      primary study outcome at 5 month follow-up is weight change; secondary outcomes include
      change in blood pressure, dietary intake, physical activity, and quality of life measures.
    

Intervention name(s): Special Intervention; Delayed Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 week behavioral weight loss intervention included 2 hour weekly group sessions; During the randomized controlled trial, the Delayed Intervention (DI) group received two newsletters with study updates and general health information. Following the trial, the DI group received a 10-week weight loss program.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention