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Dose/Response of Exercise on Long Term Weight Loss

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006315
    Brief Title
    Dose/Response of Exercise on Long Term Weight Loss
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To examine the dose-response of exercise on long-term weight loss in overweight adult women.
    Detailed Description
    BACKGROUND: Exercise is a key component of behavioral weight loss programs because of its effect on weight loss, body composition, cardiovascular disease risk factors, and other obesity related diseases such as type 2 diabetes mellitus. Despite these benefits, it is unclear whether there is an optimal exercise duration and/or intensity that will enhance long-term weight loss. The current public health recommendation for physical activity is for individuals to participate in at least 30 minutes of moderate intensity physical activity on most days of the week (approximately 150 minutes per week total). However, it is unclear whether this amount of exercise is adequate for long-term weight loss. Moreover, cross-sectional studies have shown that individuals that have been successful at long-term weight loss participate in levels of physical activity that are greater than the current public health recommendations. DESIGN NARRATIVE: The researchers hypothesized that adopting higher levels of exercise duration and/or intensity, coupled with a strong behavioral intervention would enhance long-term weight loss. To test this hypothesis, they recruited 200 overweight women and randomly assigned them to one of four treatment groups: (1) moderate intensity, moderate 1000cal/wk duration exercise, (2) vigorous intensity moderate duration exercise, (3) moderate 2000cal/wk intensity, high duration exercise, and (4) vigorous intensity, high duration exercise. All subjects participated in a 24-month behavioral weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the interventionists. In addition, to facilitate the adoption of the exercise protocols, all subjects were provided with a home treadmill. Assessment of body weight occured at 0, 6, 12, and 24 months and exercise participation was measured throughout the program. In addition, body composition, cardiorespiratory fitness, cardiovascular disease risk factors, and mediators of behavior change were measured at 0, 6, 12, and 24 months. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Obesity

    7. Study Design

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Jakicic
    Organizational Affiliation
    University of Pittsburgh

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12370568
    Citation
    Jakicic JM, Wing RR, Winters-Hart C. Relationship of physical activity to eating behaviors and weight loss in women. Med Sci Sports Exerc. 2002 Oct;34(10):1653-9. doi: 10.1097/00005768-200210000-00018.
    Results Reference
    background
    PubMed Identifier
    12715973
    Citation
    Jakicic JM, Gallagher KI. Exercise considerations for the sedentary, overweight adult. Exerc Sport Sci Rev. 2003 Apr;31(2):91-5. doi: 10.1097/00003677-200304000-00007.
    Results Reference
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    PubMed Identifier
    12468633
    Citation
    Jakicic JM. The role of physical activity in prevention and treatment of body weight gain in adults. J Nutr. 2002 Dec;132(12):3826S-3829S. doi: 10.1093/jn/132.12.3826S.
    Results Reference
    background
    PubMed Identifier
    12226138
    Citation
    Gallagher KI, Jakicic JM, Kiel DP, Page ML, Ferguson ES, Marcus BH. Impact of weight-cycling history on bone density in obese women. Obes Res. 2002 Sep;10(9):896-902. doi: 10.1038/oby.2002.123.
    Results Reference
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    PubMed Identifier
    12966123
    Citation
    Jakicic JM, Marcus BH, Gallagher KI, Napolitano M, Lang W. Effect of exercise duration and intensity on weight loss in overweight, sedentary women: a randomized trial. JAMA. 2003 Sep 10;290(10):1323-30. doi: 10.1001/jama.290.10.1323.
    Results Reference
    background
    PubMed Identifier
    18663167
    Citation
    Jakicic JM, Marcus BH, Lang W, Janney C. Effect of exercise on 24-month weight loss maintenance in overweight women. Arch Intern Med. 2008 Jul 28;168(14):1550-9; discussion 1559-60. doi: 10.1001/archinte.168.14.1550. Erratum In: Arch Intern Med. 2008 Oct 27;168(19):2162.
    Results Reference
    derived

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