Study to Promote Physical Activity Among Overweight Persons

NCT ID: NCT00313040

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-06-30

Brief Summary

Recent research suggests that overweight persons who are physically active may be significantly less likely to develop health complications and less likely to die early when compared even with lean persons who are not physically active. Previous treatment programs for people who have struggled with their weight have focused almost entirely on weight loss as the main goal of treatment. Our research program has a different focus. We hope to improve health and healthy self esteem independent of body weight by focusing instead on increasing physical activity as the main goal of treatment. This is a small study designed to see if this approach would be appealing to persons who are struggling with their weight who are currently sedentary. It is designed for people who are otherwise fairly healthy for whom exercise is reasonably safe. Participants are randomly (by chance) assigned to participate in the experimental treatment program or instead to meet with their regular primary care doctor. Those who are assigned to meet with their regular doctor can access traditional weight loss resources such as Weight Watchers, Jenny Craig, Fitness centers etc... After the experiment is complete, these participants will have the opportunity to participate in the experimental treatment program.

Detailed Description

OBJECTIVE: Epidemiologic evidence suggests that overweight persons who engage in modest amounts of physical activity - even that insufficient to produce or maintain weight loss - are at significantly reduced risk for health complications including all-cause mortality. Interventions for overweight persons targeting increased physical activity rather than weight loss as the main outcome of treatment have not been well studied and could represent simpler, more sustainable, and more cost-effective approaches in addressing the obesity epidemic.

METHOD: Pilot randomized controlled trial. Sedentary patients with BMI 25-45, and no major contraindications for unsupervised physical activity recruited. Participants randomized to receive either brief consultation consisting of 3 in-person meetings, a workbook, and limited telephone contact or usual care with their medical provider including access to community weight-loss groups/resources. Intervention therapists novice pre-professional students. The intervention is manualized and coded for treatment integrity. The main outcome measures are Cohen's d effect sizes and 95% confidence intervals for the change in moderate-equivalent intensity physical activity/week at 3 months relative to baseline assessed by a blinded assessor using the Stanford 7-Day Physical Activity Recall. Secondary outcomes include effect sizes and confidence intervals for changes in cardiorespiratory fitness and depression using the modified Canadian Aerobic Fitness test and Beck Depression Inventory. Analyses to be performed by intention to treat. Missing data to be imputed by baseline observation carried forward.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Brief Consultation with Health Counselor, workbook

Intervention Type: BEHAVIORAL

Usual Care wait list

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI 25-45
• not regularly physically active by staging algorithm (Norman et al,1998)
• AHA/ACSM risk class A1-A3 apparently healthy with no contraindications to medically unsupervised physical activity
• physician consent

Exclusion Criteria

• BMI<25; BMI>45
• regularly physically active by staging algorithm (Norman et al,1998)
• AHA/ACSM risk class B or C contraindication for medically unsupervised physical activity
• physician will not consent
• diagnosis of dementia, psychotic disorder
• legal guardian or conservator appointed
• anorexia
• bulimia
• live more than one hour commute from Stanford
• no reliable means of transportation to scheduled appointments at Stanford
• unable to followup for duration of study period as result of planned move
• female and sexually active without birth control or planning to become pregnant
• unable to read and write in English
• friend or family member of enrolled participant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Cholestech Corporation

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Principal Investigators

Anthony J Mascola, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

References

Mascola AJ, Yiaslas TA, Meir RL, McGee SM, Downing NL, Beaver KM, Crane LB, Agras S. Framing physical activity as a distinct and uniquely valuable behavior independent of weight management: a pilot randomized controlled trial for overweight and obese sedentary persons. Eat Weight Disord. 2009 Jun-Sep;14(2-3):e148-52. doi: 10.1007/BF03327814.

Reference Type: RESULT

PMID: 19934630 (View on PubMed)

Other Identifiers

79940

Identifier Type: -

Identifier Source: org_study_id