Effect of Exercise on Prevention of Weight Gain

Weight Loss Clinical Trial

Official title:

Effect of Exercise on Prevention of Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177502
• Other study ID #: R01HL070257-01A1
• Secondary ID: R01HL070257-01A1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: January 2003
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Weight Gain
• Weight Loss

Intervention

Behavioral:
• behavioral exercise intervention

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight
Secondary	fitness
Secondary	physical activity
Secondary	dietary intake
Secondary	mediators