NCT00313040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

April 7, 2006

Last Update Submit

June 8, 2011

Conditions

OverweightObesity

Keywords

physical activitysedentarybehavioral medicinemotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • 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)

  • +11 more secondary outcomes

Interventions

Brief Consultation with Health Counselor, workbookBEHAVIORAL
Usual Care wait listBEHAVIORAL

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305-5722, United States

Location

Related Publications (1)

  • 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.

    PMID: 19934630RESULT

MeSH Terms

Conditions

OverweightObesityMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Anthony J Mascola, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

March 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(1)