Data Analysis of a Managed Care Weight Reduction Trial

Obesity Clinical Trial

Official title:

Data Analysis of a Managed Care Weight Reduction Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674180
• Other study ID #: 2008-833
• Status: Completed
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: January 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		1 year
Secondary	diabetes and cardiovascular risk		1 year