Weight Loss Maintenance (WLM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00054925
First received: February 13, 2003
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Diabetes Mellitus, Non-insulin Dependent
Hypertension
Behavioral: Personal contact (PC)
Behavioral: Interactive technology (IT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Weight Loss Maintenance (WLM)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Weight [ Time Frame: Baseline to 30 months ] [ Designated as safety issue: No ]

Enrollment: 1685
Study Start Date: January 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Personal contact (PC)
The Personal Contact (PC) intervention offers one-on-one guidance and support in maintaining weight loss.
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.
Active Comparator: Interactive technology (IT)
Utilizes internet and automated phone technology to enhance the frequency and timeliness of feedback.
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.

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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054925

Sponsors and Collaborators
Duke University
Investigators
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
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00054925     History of Changes
Other Study ID Numbers: Pro00013066, U01HL068734
Study First Received: February 13, 2003
Last Updated: March 6, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Weight Loss
Cardiovascular Diseases
Heart Diseases
Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight Changes
Body Weight
Signs and Symptoms
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014