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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00054925 |
To determine the effectiveness of continuous patient contact on weight loss maintenance.
Condition | Intervention | Phase |
---|---|---|
Cardiovascular Diseases Heart Diseases Obesity Diabetes Mellitus, Non-Insulin Dependent Hypertension |
Behavioral: Personal Contact Device: Interactive Web-based technology |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | Weight Loss Maintenance (WLM) |
Study Start Date: | January 2003 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
BACKGROUND:
Overweight/obesity is the second leading cause of death in the US, and is growing in prevalence at an alarming rate. Control of overweight/obesity is increasingly recognized as a high national priority because of its contribution to cardiovascular (CVD) risk factors and ultimately to CVD itself. The short-term success of behavioral interventions for weight loss has been repeatedly documented. Unfortunately, because weight re-gain is extremely common, a disappointingly, small proportion of individuals achieve long-term weight control. Of the factors that are associated with sustained weight loss, one of the most important is continued intervention with frequent contacts.
DESIGN NARRATIVE:
The study is a multi-center, randomized, controlled trial [Weight Loss Maintenance Trial (MAINTENANCE)] to determine the effects of two innovative behavioral interventions, each designed to maintain frequent contacts, compared to a usual care control group. Overweight and obese individuals (60% women, 40% African Americans) who are taking medication for hypertension, dyslipidemia and/or type 2 diabetes will enter a 6-month, weight loss program. Those 800 individuals who lose at least 4 kg (approximately 9 pounds) will then be randomized into one of three groups: a Personal Contact (PC) Intervention that provides monthly personal contacts with a trained interventionist, primarily via telephone; an Interactive Technology (IT) Intervention that provides frequent contacts through a state-of-the-art interactive web-based program supplemented by other communication technologies; or Usual Care (UC). The primary outcome will be weight change from the end of the initial weight loss program to the end of the 30-month weight maintenance intervention period. Other outcomes will include weight change in subgroups, prevalence of CVD risk factors, measures of behavior change, and cost of implementation. For each outcome, the Personal Contact and Interactive Technology interventions will be compared to Usual Care and, if different from Usual Care, to each other. To successfully combat the obesity epidemic, clinicians and health care systems must have options that are effective and feasible and that can be provided to large numbers of individuals.
Phase II intervention completed: July 2007
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Overweight men and women who took medication for hypertension, type 2 diabetes and/or hyperlipidemia in the six month weight loss phase. and who were able to lose approximately 9 pounds. There will be approximately 60% women and 40% African Americans.
Investigator: | Lawrence Appel | Johns Hopkins University |
Investigator: | Phillip Brantley | LSU Pennington Biomedical Research Center |
Investigator: | Jack Hollis | Kaiser Foundation Research Institute |
Investigator: | Victor Stevens | Kaiser Foundation Research Institute |
Investigator: | Laura Svetkey | Duke University |
Study ID Numbers: | 156 |
Study First Received: | February 13, 2003 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00054925 |
Health Authority: | United States: Federal Government |
Obesity Heart Diseases Metabolic Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Weight Loss Diabetes Mellitus, Type 2 Body Weight Changes Nutrition Disorders Overnutrition Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypertension |
Cardiovascular Diseases |