The Weight-Wise Weight Loss Translation Study

This study has been completed.
Sponsor:
Collaborators:
Davidson County Health Department
Forsyth County Health Department
Lincoln County Health Department
Nash County Health Department
Albemarle Regional Health Services
Warren County Health Department
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01141348
First received: May 6, 2010
Last updated: June 9, 2010
Last verified: June 2010

May 6, 2010
June 9, 2010
January 2009
January 2010   (final data collection date for primary outcome measure)
Weight Change difference between baseline and 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141348 on ClinicalTrials.gov Archive Site
Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Weight-Wise Weight Loss Translation Study
Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Cardiovascular Disease
  • Behavioral: Special Intervention
    16 week behavioral weight loss intervention included 2 hour weekly group sessions
  • Behavioral: Delayed Intervention
    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.
  • Experimental: Special Intervention
    Intervention: Behavioral: Special Intervention
  • Experimental: Delayed Intervention
    Intervention: Behavioral: Delayed Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. BMI between 27.5 and 45
  2. willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
  3. English-speaking
  4. able and willing to give informed consent
  5. household income less than or equal to 250% of federal poverty guidelines.

Exclusion Criteria:

  1. medical or physical limitations to engaging in moderate level physical activity
  2. medical or other contraindications to weight loss
  3. history of gastric bypass surgery or scheduled surgery for this purpose
  4. weight loss of > 20 lbs in the last 3 months
  5. current use of medication for weight loss
  6. treatment of psychosis
  7. diagnosis of Type 1 diabetes.
Female
40 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141348
08-0055
Yes
Carmen Samuel-Hodge, PhD, MS, RD, University of North Carolina - Center for Health Promotion and Disease Prevention
University of North Carolina, Chapel Hill
  • Centers for Disease Control and Prevention
  • Davidson County Health Department
  • Forsyth County Health Department
  • Lincoln County Health Department
  • Nash County Health Department
  • Albemarle Regional Health Services
  • Warren County Health Department
Principal Investigator: Carmen Samuel-Hodge, PhD, MS, RD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP