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Sponsors and Collaborators: |
University of North Carolina Centers for Disease Control and Prevention North Carolina Department of Health and Human Services |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00288301 |
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.
Condition | Intervention |
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Overweight Obesity |
Behavioral: Weight loss intervention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | North Carolina WISEWOMAN Study - Weight-Wise Program |
Enrollment: | 151 |
Study Start Date: | February 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Special Intervention
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Behavioral: Weight loss intervention
weight loss intervention
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2: Experimental
Delayed intervention
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Behavioral: Weight loss intervention
weight loss intervention
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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.
Ages Eligible for Study: | 40 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
New Hanover Community Health Center | |
Wilmington, North Carolina, United States, 28401 |
Principal Investigator: | Carmen Samuel-Hodge, PhD, RD | The University of North Carolina, Chapel Hill |
Responsible Party: | The Unviersity of North Carolina at Chapel Hill ( Beverly Garcia ) |
Study ID Numbers: | 00893-05 |
Study First Received: | February 6, 2006 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00288301 |
Health Authority: | United States: Federal Government |
diet physical activity weight management |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |