Data Analysis of a Managed Care Weight Reduction Trial

NCT00674180 | Completed

• 1 other identifier: 2008-833
• Study Type: observational
• Target: 588
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• weight loss

  1 year

Secondary Outcomes (1)

• diabetes and cardiovascular risk

  1 year

Study Arms (3)

1

a workbook alone

Behavioral: Workbook

2

a workbook alone and the addition of computerized tailoring using onsite computer kiosks with touch screen monitors

Behavioral: Workbook; Behavioral: Computer Intervention

3

a workbook, the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and staff consultations.

Behavioral: Workbook; Behavioral: Computer Intervention; Behavioral: Staff Consultation

Interventions

Workbook BEHAVIORAL

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.

1; 2; 3

Computer Intervention BEHAVIORAL

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.

2; 3

Staff Consultation BEHAVIORAL

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.

3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Related Publications (2)

• 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. doi: 10.1016/s0002-8223(01)00284-x.

  PMID: 11678486 RESULT

• Swencionis C, Wylie-Rosett J, Lent MR, Ginsberg M, Cimino C, Wassertheil-Smoller S, Caban A, Segal-Isaacson CJ. Weight change, psychological well-being, and vitality in adults participating in a cognitive-behavioral weight loss program. Health Psychol. 2013 Apr;32(4):439-46. doi: 10.1037/a0029186. Epub 2012 Aug 13.

  PMID: 22888821 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Wylie-Rosett, EdD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Charles Swencionis, PhD

  Yeshiva University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Epidemiology & Population Health

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: January 1, 2010
• Last Updated: January 10, 2020

Record last verified: 2020-01