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Sponsors and Collaborators: |
Stanford University National Institute of Mental Health (NIMH) Cholestech Corporation |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00313040 |
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.
Condition | Intervention | Phase |
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Overweight Obesity |
Behavioral: Brief Consultation with Health Counselor, workbook Behavioral: Usual Care wait list |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Promoting Increased Physical Activity as the Main Outcome of Treatment for Overweight Persons: A Pilot Randomized Controlled Trial |
Estimated Enrollment: | 30 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5722 |
Principal Investigator: | Anthony J Mascola, MD | Stanford University |
Study ID Numbers: | 79940 |
Study First Received: | April 7, 2006 |
Last Updated: | April 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00313040 History of Changes |
Health Authority: | United States: Institutional Review Board |
physical activity sedentary behavioral medicine motivational interviewing |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |