Enhancing Exercise Participation in Overweight Adults

September 12, 2005 updated by: University of Pittsburgh
The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

225

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Female or Male
  2. 18-55 years of age
  3. BMI = 25-39.9 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 18 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)
  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. Weight loss of >5% of body weight within the previous 12 months.
  9. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
body weight

Secondary Outcome Measures

Outcome Measure
physical activity
Fitness
dietary intake
mediators

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institutes of Health (NIH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HL067826-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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