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Study to Promote Physical Activity Among Overweight Persons

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ClinicalTrials.gov Identifier: NCT00313040
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : June 10, 2011
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Cholestech Corporation
Information provided by:
Stanford University

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Brief Consultation with Health Counselor, workbook Behavioral: Usual Care wait list Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Promoting Increased Physical Activity as the Main Outcome of Treatment for Overweight Persons: A Pilot Randomized Controlled Trial
Study Start Date : March 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups

Secondary Outcome Measures :
  1. Effect size and 95% CI for change in Cardiorespiratory Fitness at 3 months by modified Canadian Aerobic Fitness Test
  2. Effect size and 95% CI for change in Depression by Beck Depression Inventory at 3 months
  3. Physical Activity Staging Algorithm (Norman, 1998)
  4. Motives for Physical Activity Measure (Ryan et al, 1997)
  5. Self Efficacy for Overcoming Barriers to Exercise (Garcia and King, 1991)
  6. Outcomes Expectancies for Exercise (Mascola 2004)
  7. Health Care Climate Questionnaire (Williams, 1996)
  8. General Causality Orientations Scale (Deci and Ryan)
  9. Treatment Self Regulation Questionnaire (Deci and Ryan)
  10. Mediators of Exercise Questionnaire (Mascola)
  11. Cholestech LDX lipoprotein and glucose profile
  12. Resting Heart Rate
  13. Blood Pressure Omron automated sphygmomanometer
  14. Waist Circumference
  15. Percent Body Fat Omron bioelectric impedence
  16. Polar OwnIndex score


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313040


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5722
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Cholestech Corporation
Investigators
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Principal Investigator: Anthony J Mascola, MD Stanford University

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00313040     History of Changes
Other Study ID Numbers: 79940
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Stanford University:
physical activity
sedentary
behavioral medicine
motivational interviewing

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms