The Weight-Wise Weight Loss Translation Study

Obesity Clinical Trial

— Weight-Wise  

Official title:

Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141348
• Other study ID #: 08-0055
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: June 9, 2010
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity
• Overweight

Intervention

Behavioral:
• Special Intervention
16 week behavioral weight loss intervention included 2 hour weekly group sessions
• 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.

Locations

Country	Name	City	State
United States	Albemarle Regional Health Services	Elizabeth City	North Carolina
United States	Davidson County Health Department	Lexington	North Carolina
United States	Lincoln County Health Department	Lincolnton	North Carolina
United States	Nash County Health Department	Nashville	North Carolina
United States	Warren County Health Department	Warrenton	North Carolina
United States	Forsyth County Health Department	Winston-Salem	North Carolina

Sponsors (8)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Albemarle Regional Health Services, Centers for Disease Control and Prevention, Davidson County Health Department, Forsyth County Health Department, Lincoln County Health Department, Nash County Health Department, Warren County Health Department

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change difference between baseline and 4 month follow-up		Baseline and 4 month follow-up	No
Secondary	Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up		Baseline and 4 month follow-up	No