Effect of Exercise on Prevention of Weight Gain

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177502
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 294
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Weight Loss	Behavioral: behavioral exercise intervention	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Exercise on Prevention of Weight Gain
• Study Start Date: Jan 1, 2003
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. body weight []

Secondary Outcome Measures

1. fitness []

2. physical activity []

3. dietary intake []

4. mediators []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15203

Sponsors and Collaborators

• University of Pittsburgh
• National Institutes of Health (NIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00177502
• Other Study ID Numbers: R01HL070257-01A1; R01HL070257-01A1
• First Posted: Sep 15, 2005
• Last Update Posted: Sep 15, 2005
• Last Verified: Sep 1, 2005

• Additional relevant MeSH terms: Body Weight; Weight Loss; Weight Gain

Study Results

No Results Posted as of Sep 15, 2005