Clinical trial NCT01141348: The Weight-Wise Weight Loss Translation Study
Official title: Intensive Behavioral Weight Management in Public Health Settings: Weight-Wise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Cardiovascular Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Davidson County Health Department
name: Forsyth County Health Department
name: Lincoln County Health Department
name: Nash County Health Department
name: Albemarle Regional Health Services
name: Warren County Health Department
First posted: 2010-06-10
Enrollment: 189
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Weight Change difference between baseline and 4 month follow-up
timeFrame: Baseline and 4 month follow-up
Secondary outcomes:
measure: Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up
timeFrame: Baseline and 4 month follow-up
Other outcomes:
Locations:
city: Elizabeth City
country: United States
facility: Albemarle Regional Health Services
state: North Carolina
city: Lexington
country: United States
facility: Davidson County Health Department
state: North Carolina
city: Lincolnton
country: United States
facility: Lincoln County Health Department
state: North Carolina
city: Nashville
country: United States
facility: Nash County Health Department
state: North Carolina
city: Warrenton
country: United States
facility: Warren County Health Department
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth County Health Department
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen Samuel-Hodge, PhD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.