NCT00067873

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 20, 2017

Status Verified

October 1, 2017

Enrollment Period

7 years

First QC Date

August 29, 2003

Last Update Submit

November 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    6 months

  • Change in weight after initial weight loss

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

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

Secondary Outcomes (10)

  • Insulin sensitivity

    6 months post baseline

  • Insulin sensitivity

    18 months post baseline

  • Change in visceral fat

    6 months post baseline

  • Change in visceral fat

    18 months post baseline

  • Change in cholesterol

    6 months post baseline

  • +5 more secondary outcomes

Study Arms (3)

Diet only

ACTIVE COMPARATOR
Behavioral: Diet

Diet plus aerobic exercise

EXPERIMENTAL
Behavioral: DietBehavioral: Aerobic exercise

Diet plus resistance exercise

EXPERIMENTAL
Behavioral: DietBehavioral: Resistance exercise

Interventions

DietBEHAVIORAL
Diet onlyDiet plus aerobic exerciseDiet plus resistance exercise
Diet plus aerobic exercise
Diet plus resistance exercise

Eligibility Criteria

Age21 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
* Normoglycemic * BMI between 27-30 * Non smoker * Premenopausal * Physically untrained * Family history of obesity

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

DietExerciseResistance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Gary R Hunter, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 29, 2003

First Posted

September 1, 2003

Study Start

December 1, 2000

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 20, 2017

Record last verified: 2017-10

Locations