North Carolina WISEWOMAN: Weight-Wise Pilot Study
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): weight loss intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: diet; physical activity; weight management