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Weight Loss Maintenance (WLM) (WLM)

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ClinicalTrials.gov Identifier: NCT00054925
Recruitment Status : Completed
First Posted : February 14, 2003
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE February 13, 2003
First Posted Date  ICMJE February 14, 2003
Last Update Posted Date March 7, 2012
Study Start Date  ICMJE January 2003
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
Change in Weight [ Time Frame: Baseline to 30 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00054925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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

Phase III intervention completed: October 2009

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Obesity
  • Diabetes Mellitus, Non-insulin Dependent
  • Hypertension
Intervention  ICMJE
  • Behavioral: Personal contact (PC)
    This arm uses brief, individual contacts on a monthly basis which emphasize core elements of weight maintenance. Monthly contacts with an interventionist occur for 30 months after the end of Phase I. Face-to-face contacts occur approximately every four months (e.g., three annually), with telephone contacts occurring every month between FTF contacts.
  • Behavioral: Interactive technology (IT)
    The website utilizes collaborative goal setting and problem-solving strategies to identify contingent action plans for perceived obstacles to success. In order to tailor the intervention to the needs of the participant, the action plan can be updated anytime and as frequently as desired by the individual. Participants are encouraged to input data on weight, food records, physical activity, and goals on a weekly basis. Participants are not restricted to logging on to the website only once a week. Rather, participants have the option of logging on to the website to enter data, communicate with other participants, or to seek other information, as frequently as they wish.
Study Arms  ICMJE
  • Active Comparator: Personal contact (PC)
    The Personal Contact (PC) intervention offers one-on-one guidance and support in maintaining weight loss.
    Intervention: Behavioral: Personal contact (PC)
  • Active Comparator: Interactive technology (IT)
    Utilizes internet and automated phone technology to enhance the frequency and timeliness of feedback.
    Intervention: Behavioral: Interactive technology (IT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2012)
1685
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054925
Other Study ID Numbers  ICMJE Pro00013066
U01HL068734 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Lawrence Appel Johns Hopkins University
Principal Investigator: Phillip Brantley LSU Pennington Biomedical Research Center
Principal Investigator: Jack Hollis Kaiser Foundation Research Institute
Principal Investigator: Victor Stevens Kaiser Foundation Research Institute
Study Chair: Laura Svetkey Duke University
PRS Account Duke University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP