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Enhancing Exercise Participation in Overweight Adults

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 1
Locations
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 Weight Loss

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    body weight

    Secondary Outcome Measures

    Fitness
    physical activity
    dietary intake
    mediators

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 12, 2005
    Sponsor
    University of Pittsburgh
    Collaborators
    National Institutes of Health (NIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00177476
    Brief Title
    Enhancing Exercise Participation in Overweight Adults
    Official Title
    Enhancing Exercise Participation in Overweight Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2006 (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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    225 (false)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female or Male 18-55 years of age BMI = 25-39.9 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. 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) 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. Weight loss of >5% of body weight within the previous 12 months. 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25160843
    Citation
    Jakicic JM, Rickman AD, Lang W, Davis KK, Gibbs BB, Neiberg R, Marcus MD. Time-based physical activity interventions for weight loss: a randomized trial. Med Sci Sports Exerc. 2015 May;47(5):1061-9. doi: 10.1249/MSS.0000000000000482.
    Results Reference
    derived
    PubMed Identifier
    20145731
    Citation
    Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
    Results Reference
    derived

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    Enhancing Exercise Participation in Overweight Adults

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