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ObesityNCT00067873

Exercise Training in Obesity-prone Black and White Women

A study testing Diet, Aerobic exercise and Resistance exercise in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Read more about this study

Who is it for?
Ages 21 to 41 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Diet, Aerobic exercise and Resistance exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
1 siteUnited States
Study dates
Dec 2000to Dec 2007
Phase
Interventional
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 21 to 41 years
  • Women only
  • Healthy volunteers accepted
  • Adult
  • Normoglycemic
  • BMI between 27-30
  • Non smoker
  • Premenopausal
  • Physically untrained
  • Family history of obesity

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.

Read the detailed description

Overweight premenopausal Black and White women are randomized to either diet-only, diet+aerobic or diet+resistance exercise training. Diet/behavior intervention, with or without the aerobic or resistance exercise training, will be provided throughout the 18 months of study. Major outcomes will include measures of perceived and physiologic difficulty of exercise (cardiac, ventilatory, electromyographic responses to standardized exercise tasks); aerobic fitness; strength fitness; and spontaneous free-living energy expenditure (all derived from doubly labeled water). The results will provide insight into the effectiveness of, and the mechanisms by which, different types of exercise training can improve physical fitness, spontaneous engagement in physical activities of daily living and, in turn, weight-loss maintenance.

Time of initial weight loss was defined as the time needed to reach the goal of 25 kg/m2 BMI. The women will then be evaluated one year after this time and the amount of weight gain will be determined.

Conditions
Obesity
Being tested
Diet, Aerobic exercise, Resistance exercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00067873
Study groupRoleWhat they receive
Diet onlyActive comparatorNot described
Receives: Behavioral: Diet
Diet plus aerobic exerciseExperimentalNot described
Receives: Behavioral: Diet; Behavioral: Aerobic exercise
Diet plus resistance exerciseExperimentalNot described
Receives: Behavioral: Diet; Behavioral: Resistance exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    Measured: 6 months

  2. Change in weight after initial weight loss

    Time of initial weight loss determined by days to reach BMI <= 25 (maximum 6 months)

    Measured: 12 months after initial weight loss (maximum 18 months after randomization)

Secondary outcomes (10)

  1. Insulin sensitivity

    Measured: 6 months post baseline

  2. Insulin sensitivity

    Measured: 18 months post baseline

  3. Change in visceral fat

    Measured: 6 months post baseline

  4. Change in visceral fat

    Measured: 18 months post baseline

  5. Change in cholesterol

    Measured: 6 months post baseline

  6. Change in cholesterol

    Measured: 18 months post baseline

  7. Change in triglycerides

    Measured: 6 months post baseline

  8. Change in triglycerides

    Measured: 18 months post baseline

  9. Change in resting energy expenditure

    Measured: 6 months post baseline

  10. Change in resting energy expenditure

    Measured: 18 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2003 (estimated)
  2. Study startDec 2000
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067873
Sponsor's protocol ID
BLKWHT (DK49779) (completed)
Other IDs
R01DK049779
Status last verified
Oct 2017
First submitted
29 Aug 2003
Last updated
20 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hunter GR, Fisher G, Neumeier WH, Carter SJ, Plaisance EP. Exercise Training and Energy Expenditure following Weight Loss. Med Sci Sports Exerc. 2015 Sep;47(9):1950-7. doi: 10.1249/MSS.0000000000000622.

    PubMed 25606816

  • Hunter GR, Brock DW, Byrne NM, Chandler-Laney PC, Del Corral P, Gower BA. Exercise training prevents regain of visceral fat for 1 year following weight loss. Obesity (Silver Spring). 2010 Apr;18(4):690-5. doi: 10.1038/oby.2009.316. Epub 2009 Oct 8.

    PubMed 19816413

  • Elshakankiry AM, Hunter GR, Martins C, Fisher G, Garvey WT, Howell CR. Weight Loss Improves Predicted 10-Year MACE and Type 2 Diabetes Risk, but Benefits Partially Rebound at 1 Year. Obesity (Silver Spring). 2026 Aug 23. doi: 10.1002/oby.70291. Online ahead of print.

    PubMed 42634098

  • Bartholomew CL, Martins C, Gower B. The Role of Insulin Sensitivity in Lean Mass Changes During Weight Loss With or Without Exercise. Obesity (Silver Spring). 2025 Nov;33(11):2103-2111. doi: 10.1002/oby.70010. Epub 2025 Sep 2.

    PubMed 40898644

  • Martins C, Gower BA, Hunter GR. Changes in Trunk, but Not Limb, Lean Body Mass Contribute to Variability in Metabolic Adaptation Following Weight Loss. Obes Sci Pract. 2025 Mar 19;11(2):e70054. doi: 10.1002/osp4.70054. eCollection 2025 Apr.

    PubMed 40110172

  • Martins C, Gower BA, Hunter GR. Association between Fat-Free Mass Loss after Diet and Exercise Interventions and Weight Regain in Women with Overweight. Med Sci Sports Exerc. 2022 Dec 1;54(12):2031-2036. doi: 10.1249/MSS.0000000000002992. Epub 2022 Jul 8.

    PubMed 35797356

  • Martins C, Gower BA, Hill JO, Hunter GR. Metabolic adaptation is not a major barrier to weight-loss maintenance. Am J Clin Nutr. 2020 Sep 1;112(3):558-565. doi: 10.1093/ajcn/nqaa086.

    PubMed 32386226

  • Brock DW, Tompkins CL, Fisher G, Hunter GR. Influence of resting energy expenditure on blood pressure is independent of body mass and a marker of sympathetic tone. Metabolism. 2012 Feb;61(2):237-41. doi: 10.1016/j.metabol.2011.06.019. Epub 2011 Aug 4.

    PubMed 21820136

  • Brock DW, Chandler-Laney PC, Alvarez JA, Gower BA, Gaesser GA, Hunter GR. Perception of exercise difficulty predicts weight regain in formerly overweight women. Obesity (Silver Spring). 2010 May;18(5):982-6. doi: 10.1038/oby.2009.318. Epub 2009 Oct 8.

    PubMed 19816412

Questions about this trial

What is this clinical trial studying?

A study testing Diet, Aerobic exercise and Resistance exercise in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does the primary outcome measure?

Weight loss (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067873, which also lists 9 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 20 Nov 2017.

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