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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | February 13, 2003 | ||||||||||||||||||||
| Last Updated Date | October 7, 2008 | ||||||||||||||||||||
| Start Date ICMJE | January 2003 | ||||||||||||||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00054925 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Weight Loss Maintenance (WLM) | ||||||||||||||||||||
| Official Title ICMJE | Weight Loss Maintenance (WLM) | ||||||||||||||||||||
| Brief Summary | To determine the effectiveness of continuous patient contact on weight loss maintenance. |
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| Detailed Description | 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 |
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| Study Phase | Phase III | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Prevention, Randomized | ||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||||||
| Completion Date | June 2007 | ||||||||||||||||||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||||||||||||||||||
| Ages | 25 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | |||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00054925 | ||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||
| Study ID Numbers ICMJE | 156 | ||||||||||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||
| Verification Date | October 2008 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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