Expired Study
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Pittsburgh, Pennsylvania 15203


Purpose:

The purpose of this study is to examine the dose-response of exercise on prevention of weight gain in overweight adults.


Criteria:

Inclusion Criteria: 1. Female or Male 2. 18-55 years of age 3. BMI = 25-29.9 kg/m2 4. Ability to provide informed consent. 5. Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: 1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.) 2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 3. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, this will be confirmed with the urine pregnancy test that will be conducted prior to the baseline DEXA.) 4. Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure. 5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). 6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. 7. History of myocardial infarction or valvular disease. 8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).


Study is Available At:


Original ID:

R01 HL070257-01A1


NCT ID:

NCT00177502


Secondary ID:

R01 HL070257-01A1


Study Acronym:


Brief Title:

Effect of Exercise on Prevention of Weight Gain


Official Title:

Effect of Exercise on Prevention of Weight Gain


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

294


Enrollment Type:


Overall Contact Information

Official Name:John M Jakicic, Ph.D.
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:January 2003
Completion Date:December 2006
Verification Date:September 2005
Last Changed Date:September 12, 2005
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:body weight
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:fitness
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:physical activity
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:dietary intake
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:mediators
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:behavioral exercise intervention

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pittsburgh
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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