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
  Purpose

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.


Condition Intervention
Overweight
Obesity
Cardiovascular Disease
Behavioral: Special Intervention
Behavioral: Delayed Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Weight Change difference between baseline and 4 month follow-up [ Time Frame: Baseline and 4 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 189
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Special Intervention Behavioral: Special Intervention
16 week behavioral weight loss intervention included 2 hour weekly group sessions
Experimental: Delayed Intervention 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141348

Locations
United States, North Carolina
Albemarle Regional Health Services
Elizabeth City, North Carolina, United States, 27907
Davidson County Health Department
Lexington, North Carolina, United States, 27293
Lincoln County Health Department
Lincolnton, North Carolina, United States, 28092
Nash County Health Department
Nashville, North Carolina, United States, 27856
Warren County Health Department
Warrenton, North Carolina, United States, 27589
Forsyth County Health Department
Winston-Salem, North Carolina, United States, 27102
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Davidson County Health Department
Forsyth County Health Department
Lincoln County Health Department
Nash County Health Department
Albemarle Regional Health Services
Warren County Health Department
Investigators
Principal Investigator: Carmen Samuel-Hodge, PhD, MS, RD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Carmen Samuel-Hodge, PhD, MS, RD, University of North Carolina - Center for Health Promotion and Disease Prevention
ClinicalTrials.gov Identifier: NCT01141348     History of Changes
Other Study ID Numbers: 08-0055
Study First Received: May 6, 2010
Last Updated: June 9, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014