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A Mentor-Based Approach to Long-Term Weight Loss

Primary Purpose

Weight Loss, Obesity

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

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

21 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female 21-55 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: 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.) Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.) 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
dietary intake
mediators

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00177697
Brief Title
A Mentor-Based Approach to Long-Term Weight Loss
Official Title
A Mentor-Based Approach to Long-Term Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.

6. Conditions and Keywords

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

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
174 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 21-55 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: 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.) Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.) 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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A Mentor-Based Approach to Long-Term Weight Loss

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