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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00177632
Other study ID # 0402119
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated September 13, 2005
Start date July 2003
Est. completion date July 2004

Study information

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

Clinical Trial Summary

The purpose is to examine the additional effect of either yoga or resistance exercise on weight loss weight combined with a standard behavioral weight loss intervention.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria:

1. Female

2. 25-55 years of age

3. BMI = 25-35 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. Participation in regular exercise (aerobic, yoga or resistance exercise) for > 20 minutes per day on > 2 days per week for the last 3 months. (This study is designed to recruit relatively sedentary adults.)

2. Currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication.

3. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.

4. 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, pregnancy status will also be verified by the pregnancy test that is required for the baseline, 6 and 12 month DEXA).

5. 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.

6. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).

7. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.

8. History of myocardial infarction or valvular disease.

9. 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: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
behavioral weight loss


Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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