North Carolina WISEWOMAN: Weight-Wise Pilot Study

June 9, 2010 updated by: University of North Carolina, Chapel Hill

North Carolina WISEWOMAN Study - Weight-Wise Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Special Intervention
Behavioral: Weight loss intervention
weight loss intervention
EXPERIMENTAL: 2
Delayed intervention
Behavioral: Weight loss intervention
weight loss intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services

Investigators

  • Principal Investigator: Carmen Samuel-Hodge, PhD, RD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (ESTIMATE)

February 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00893-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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