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Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
behavioral weight loss
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female 25-55 years of age BMI = 25-35 kg/m2 Ability to provide informed consent. Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: 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.) Currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 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). 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. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. History of myocardial infarction or valvular disease. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Sites / Locations

  • University of Pittsburgh

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

fitness
physical activity
dietary intake
mediators

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00177632
Brief Title
Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
Official Title
Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
behavioral weight loss
Primary Outcome Measure Information:
Title
weight loss
Secondary Outcome Measure Information:
Title
fitness
Title
physical activity
Title
dietary intake
Title
mediators

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 25-55 years of age BMI = 25-35 kg/m2 Ability to provide informed consent. Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: 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.) Currently being treated for psychological disorders/conditions and/or currently taking psychotropic medication. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 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). 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. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. History of myocardial infarction or valvular disease. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Jakicic, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States

12. IPD Sharing Statement

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