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Study to Promote Physical Activity Among Overweight Persons

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief Consultation with Health Counselor, workbook
Usual Care wait list
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring physical activity, sedentary, behavioral medicine, motivational interviewing

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University Medical Center

Outcomes

Primary Outcome Measures

Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2006
Last Updated
June 8, 2011
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH), Cholestech Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00313040
Brief Title
Study to Promote Physical Activity Among Overweight Persons
Official Title
Promoting Increased Physical Activity as the Main Outcome of Treatment for Overweight Persons: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH), Cholestech Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
physical activity, sedentary, behavioral medicine, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Brief Consultation with Health Counselor, workbook
Intervention Type
Behavioral
Intervention Name(s)
Usual Care wait list
Primary Outcome Measure Information:
Title
Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups
Secondary Outcome Measure Information:
Title
Effect size and 95% CI for change in Cardiorespiratory Fitness at 3 months by modified Canadian Aerobic Fitness Test
Title
Effect size and 95% CI for change in Depression by Beck Depression Inventory at 3 months
Title
Physical Activity Staging Algorithm (Norman, 1998)
Title
Motives for Physical Activity Measure (Ryan et al, 1997)
Title
Self Efficacy for Overcoming Barriers to Exercise (Garcia and King, 1991)
Title
Outcomes Expectancies for Exercise (Mascola 2004)
Title
Health Care Climate Questionnaire (Williams, 1996)
Title
General Causality Orientations Scale (Deci and Ryan)
Title
Treatment Self Regulation Questionnaire (Deci and Ryan)
Title
Mediators of Exercise Questionnaire (Mascola)
Title
Cholestech LDX lipoprotein and glucose profile
Title
Resting Heart Rate
Title
Blood Pressure Omron automated sphygmomanometer
Title
Waist Circumference
Title
Percent Body Fat Omron bioelectric impedence
Title
Polar OwnIndex score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J Mascola, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5722
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19934630
Citation
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.
Results Reference
result

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Study to Promote Physical Activity Among Overweight Persons

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