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Clinical Trial: Weight Loss Maintenance (WLM)

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To determine the effectiveness of continuous patient contact on weight loss maintenance.

Condition Treatment or Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Diabetes Mellitus, non-insulin dependent
Hypertension
 Behavior: Personal Contact
 Device: Interactive Web-based technology

MedlinePlus related topics:  Diabetes;   Heart Diseases;   Heart Diseases--Prevention;   High Blood Pressure;   Obesity;   Vascular Diseases

Study Type: Interventional
Study Design: Prevention, Randomized

Further Study Details: 

Study start: January 2003;  Study completion: December 2007

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.

Eligibility

Ages Eligible for Study:  25 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information

Study chairs or principal investigators

Lawrence Appel,  Johns Hopkins University   
Phillip Brantley,  LSU Pennington Biomedical Research Center   
Jack Hollis,  Kaiser Foundation Research Institute   
Victor Stevens,  Kaiser Foundation Research Institute   
Laura Svetkey,  Duke University   

More Information

Study ID Numbers:  156
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  February 13, 2003
ClinicalTrials.gov Identifier:  NCT00054925
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: September 17, 2004
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