OverweightPhase 1/2NCT00313040
Study to Promote Physical Activity Among Overweight Persons
A Phase 1/2 study testing Brief Consultation with Health Counselor, workbook in people with Overweight and Obesity, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Brief Consultation with Health Counselor, workbook
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305-5722
About this study
Official title: Promoting Increased Physical Activity as the Main Outcome of Treatment for Overweight Persons: A Pilot Randomized Controlled Trial
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.
Read the 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
- Being tested
- Brief Consultation with Health Counselor, workbook, Usual Care wait list
- Keywords
- physical activity, sedentary, behavioral medicine, motivational interviewing
- Medical subject headings
- Overweight, Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Consultation with Health Counselor, workbookBehavioural
Usual Care wait listBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups
Secondary outcomes (16)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMar 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Cholestech Corporation
- Investigators
- Anthony J Mascola, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313040
- Sponsor's protocol ID
- 79940
- Status last verified
- Jun 2011
- First submitted
- 7 Apr 2006
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
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.
PubMed 19934630
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Increased Physical Activity as the Main Outcome of Treatment for Overweight Persons: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00313040
- Acronym / sponsor ID
- 79940
- Conditions
- Overweight, Obesity
- Keywords
- physical activity, sedentary, behavioral medicine, motivational interviewing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Cholestech Corporation
- Study start
- Mar 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Consultation with Health Counselor, workbook | Behavioural | – |
| Usual Care wait list | Behavioural | – |
Primary outcome
Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups
16 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Results publication: PubMed 19934630Mascola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J Mascola, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brief Consultation with Health Counselor, workbook in people with Overweight and Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect size and 95% CI for change in Physical Activity by 7 Day Physical Activity Recall at 3 months between groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.