The Weight-Wise Weight Loss Translation Study (Weight-Wise)
Primary Purpose
Overweight, Obesity, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Special Intervention
Delayed Intervention
Sponsored by

About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- BMI between 27.5 and 45
- willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
- English-speaking
- able and willing to give informed consent
- household income less than or equal to 250% of federal poverty guidelines.
Exclusion Criteria:
- medical or physical limitations to engaging in moderate level physical activity
- medical or other contraindications to weight loss
- history of gastric bypass surgery or scheduled surgery for this purpose
- weight loss of > 20 lbs in the last 3 months
- current use of medication for weight loss
- treatment of psychosis
- diagnosis of Type 1 diabetes.
Sites / Locations
- Albemarle Regional Health Services
- Davidson County Health Department
- Lincoln County Health Department
- Nash County Health Department
- Warren County Health Department
- Forsyth County Health Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Special Intervention
Delayed Intervention
Arm Description
Outcomes
Primary Outcome Measures
Weight Change difference between baseline and 4 month follow-up
Secondary Outcome Measures
Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up
Full Information
NCT ID
NCT01141348
First Posted
May 6, 2010
Last Updated
June 9, 2010
Sponsor
University of North Carolina, Chapel Hill
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT01141348
Brief Title
The Weight-Wise Weight Loss Translation Study
Acronym
Weight-Wise
Official Title
Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Cardiovascular Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Special Intervention
Arm Type
Experimental
Arm Title
Delayed Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Special Intervention
Intervention Description
16 week behavioral weight loss intervention included 2 hour weekly group sessions
Intervention Type
Behavioral
Intervention Name(s)
Delayed Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Change difference between baseline and 4 month follow-up
Time Frame
Baseline and 4 month follow-up
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI between 27.5 and 45
willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
English-speaking
able and willing to give informed consent
household income less than or equal to 250% of federal poverty guidelines.
Exclusion Criteria:
medical or physical limitations to engaging in moderate level physical activity
medical or other contraindications to weight loss
history of gastric bypass surgery or scheduled surgery for this purpose
weight loss of > 20 lbs in the last 3 months
current use of medication for weight loss
treatment of psychosis
diagnosis of Type 1 diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Samuel-Hodge, PhD, MS, RD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albemarle Regional Health Services
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27907
Country
United States
Facility Name
Davidson County Health Department
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27293
Country
United States
Facility Name
Lincoln County Health Department
City
Lincolnton
State/Province
North Carolina
ZIP/Postal Code
28092
Country
United States
Facility Name
Nash County Health Department
City
Nashville
State/Province
North Carolina
ZIP/Postal Code
27856
Country
United States
Facility Name
Warren County Health Department
City
Warrenton
State/Province
North Carolina
ZIP/Postal Code
27589
Country
United States
Facility Name
Forsyth County Health Department
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24462117
Citation
Jones SA, Evenson KR, Johnston LF, Trost SG, Samuel-Hodge C, Jewell DA, Kraschnewski JL, Keyserling TC. Psychometric properties of the modified RESIDE physical activity questionnaire among low-income overweight women. J Sci Med Sport. 2015 Jan;18(1):37-42. doi: 10.1016/j.jsams.2013.12.007. Epub 2014 Jan 1.
Results Reference
derived
Learn more about this trial
The Weight-Wise Weight Loss Translation Study
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