Data Analysis of a Managed Care Weight Reduction Trial - Full Text View

Sponsored by:	Albert Einstein College of Medicine of Yeshiva University
Information provided by:	Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:	NCT00674180

Purpose

This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. This data will also be available for economic modeling.

Condition	Intervention
Overweight Obesity	Behavioral: Workbook Behavioral: Computer Intervention Behavioral: Staff Consultation

MedlinePlus related topics: Obesity Obesity in Children Weight Control

U.S. FDA Resources

Study Type:	Observational
Official Title:	Data Analysis of a Managed Care Weight Reduction Trial

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:

weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

diabetes and cardiovascular risk [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	588
Study Start Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 a workbook alone	Behavioral: Workbook The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs.
2 a workbook alone and the addition of computerized tailoring using onsite computer kiosks with touch screen monitors	Behavioral: Workbook The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs. Behavioral: Computer Intervention The computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content.
3 a workbook, the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and staff consultations.	Behavioral: Workbook The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs. Behavioral: Computer Intervention The computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content. Behavioral: Staff Consultation The staff consultation component included 6 closed-group workshop sessions and up to 18 telephone or face-to-face consultations with a registered dietician and/or a cognitive behavioral therapist. The workshop curriculum focused on specific activities and assignments in the workbook, and it encouraged use of the computer to identify problems and issues.

Detailed Description:

This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001. Using a 3-arm, 12-month randomized clinical trial, Wylie-Rosett et al. evaluated the costs and effects of incremental components of a weight-loss program. The study included 588 individuals (BMI> 25 kg/m2) in a freestanding health maintenance organization and achieved an 81% completion rate. The intervention used a cognitive behavioral approach for tailoring lifestyle modification goals. The incremental levels of interventions included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultations. For the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. The decreases in mean BMIs for these respective intervention levels were 0.4, 0.9, and 1.2. All groups reported a decrease in energy and fat intake and an increase in blocks walked (p<.01). Intervention variables that correlated with weight loss included more computer logons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. Weight loss correlated with decreases in fasting glucose and blood pressure. Wylie-Rosett et al. (2001) concluded that, in a weight-loss program, computers can facilitate selecting behavioral change goals. More frequent usage resulted in greater weight loss, and staff counseling to augment the computer intervention achieved the most weight loss. The purpose of this study will be secondary analysis of the data collected in the original MODELS study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Participants were recruited from an HMO's patient population and from New Hyde Park, NY.

Criteria

Inclusion Criteria:

BMI of more than 25 (or a BMI of 24 or more plus 1 cardiovascular risk factor), and the willingness to follow the study protocol, which included a refundable $100 deposit

Exclusion Criteria:

Intention to move beyond commuting distance in the next 12 months,
Medical conditions that would interfere with study participation,
Unwillingness to follow the study protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674180

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

Investigators

Principal Investigator:	Judith Wylie-Rosett, EdD	Albert Einstein College of Medicine of Yeshiva University
Study Chair:	Charles Swencionis, PhD	Yeshiva University

More Information

Publications:

Wylie-Rosett J, Swencionis C, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ, Martin T, Lewis J. Computerized weight loss intervention optimizes staff time: the clinical and cost results of a controlled clinical trial conducted in a managed care setting. J Am Diet Assoc. 2001 Oct;101(10):1155-62; quiz 1163-4.

Responsible Party:	Albert Einstein College of Medicine ( Judith Wylie-Rosett, Ed.D. )
Study ID Numbers:	2008-833
Study First Received:	May 5, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00674180 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on May 07, 2009