Cardiovascular DiseasesNCT00006315
Dose/Response of Exercise on Long Term Weight Loss
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the dose-response of exercise on long-term weight loss in overweight adult women. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To examine the dose-response of exercise on long-term weight loss in overweight adult women.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startSep 1999
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John Jakicic, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006315
- Sponsor's protocol ID
- 923
- Other IDs
- R01HL064991
- Status last verified
- May 2005
- First submitted
- 28 Sep 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
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.
PubMed 12370568Jakicic 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.
PubMed 12715973Jakicic 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.
PubMed 12468633Gallagher 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.
PubMed 12226138Jakicic 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.
PubMed 12966123Jakicic 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.
PubMed 18663167
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose/Response of Exercise on Long Term Weight Loss
- ClinicalTrials.gov ID
- NCT00006315
- Acronym / sponsor ID
- 923
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2004 (actual)
- First posted
- 29 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 12370568Jakicic 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.
- Background: PubMed 12715973Jakicic 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.
- Background: PubMed 12468633Jakicic 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.
- Background: PubMed 12226138Gallagher 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.
- Background: PubMed 12966123Jakicic 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.
- Derived from this study: PubMed 18663167Jakicic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Jakicic
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006315, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.