North Carolina WISEWOMAN: Weight-Wise Pilot Study

Obesity Clinical Trial

Official title:

North Carolina WISEWOMAN Study - Weight-Wise Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288301
• Other study ID #: 00893-05
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: June 9, 2010
• Start date: February 2005
• Est. completion date: May 2007

Study information

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

Clinical Trial Summary

The purpose of this study is to test the effectiveness of a weight loss and weight loss maintenance intervention among low income women, conducted in a community health center setting.

Description:

In the North Carolina WISEWOMAN Project, nearly three-fourths of all participants are either overweight or obese. Through control of weight, cardiovascular disease risk factors such as hypertension, dyslipidemia, and type 2 diabetes can be reduced along with their associated mortality. While there is some evidence of successful weight loss programs in the scientific literature, there are limited data on strategies to improve the weight loss outcomes of African Americans and other lower income populations and how to maintain weight loss over the long term with strategies that are feasible for health care agencies that service primarily lower income populations. We have designed a program to test intervention strategies to improve the weight loss outcomes of the WISEWOMAN population. Specifically, the purpose of the North Carolina WISEWOMAN Weight Control Pilot Study, "Weight-Wise" Program, is to test the effectiveness of a weight loss and weight loss maintenance intervention among WISEWOMAN participants, conducted in a community health center in Wilmington, NC. The Weight-Wise Program was launched in February 2005 and will continue through the Spring of 2007.

The study design and intervention are briefly described. Each WISEWOMAN participant was invited to a screening visit at the health center. During an interview with a research assistant, the participant answered a series of questions about her health history, diet, physical activity, and weight management behaviors, and psycho-social attributes. She also had her height, weight, blood pressure, and body composition measured. A non-fasting venous blood specimen was taken to measure her blood lipids (total and HDL-cholesterol) and random blood glucose. Additional baseline measures for psycho-social variables were obtained via telephone administration. Participants who completed the screening visit, phone interview, and met all eligibility requirements were randomized to two treatment groups: the Special Intervention (SI) group, and the Delayed Intervention (DI) group. Participants assigned to the SI group began the 4-month weight loss phase of the study in April 2005, while DI participants will wait until the end of this first program offering to begin the weight loss program. [DI participants are considered the 'control' group.]

The intervention program, called "Weight-Wise", consists of a four-month weight loss intervention phase, and a one-year maintenance phase. During the weight loss intervention, participants are offered 16 weekly group education sessions taught by a health counselor. The study goal for weight loss during this period is 10 or more pounds. Each session lasts about 120 minutes and includes the following elements: participant weigh-in, group sharing and problem-solving, discussion of a weight control topic (nutrition, physical activity, or behavior change), moderate physical activity and/or taste-testing. Study participants who complete the weight loss program and lose 8 or more pounds will be eligible to continue in the maintenance phase of the intervention. During the 1-year maintenance phase (which will start at the end of the weight loss phase for both SI and DI), participants in the SI group will receive 1 individual face-to-face contact with the health counselor, 8 monthly phone contacts, and 3 group sessions. The DI group will receive 1 individual face-to-face contact and 11 phone contacts from the health counselor during their maintenance intervention. After the weight loss phase and after 6 and 12 months of the maintenance intervention, both SI and DI participants will return to the clinic for follow-up data collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 64 Years

Eligibility

Inclusion Criteria:

• Women 40-64 years old

• Gross income less than or equal to 200% federal poverty level

• BMI 25-45 inclusive

• Permission of health care provider if present with diabetes or previous CVD event

• English speaking

Exclusion Criteria:

• Medical condition for which weight loss is contraindicated, e.g. malignancy or other serious illness

• CVD event in past 3 months

• Self-reported history of renal disease

• Weight loss greater than 20 lbs in last 3 months

• Any history of gastric bypass surgery, stomach stapling or liposuction

• Planning to leave area before study period ends

• Current participation in another clinical trial

• Pregnant, breastfeeding or planning a pregnancy before the end of the study

• Current use of medications to treat psychosis or manic-depressive illness

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Weight loss intervention
weight loss intervention

Locations

Country	Name	City	State
United States	New Hanover Community Health Center	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		4 months	No