NCT01664715

Brief Summary

The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels of recommended exercise in initially overweight and obese sedentary men and women on the prevention of weight regain. Participants will complete a 3 mo. weight loss intervention of decreased energy intake (EI) and increased energy expenditure (100 minutes of physical activity per week). Participants achieving clinically significant weight loss (\> 5% of initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per week. Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12 mos.).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

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

August 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

5.7 years

First QC Date

August 10, 2012

Last Update Submit

April 16, 2019

Conditions

OverweightObesityWeight Loss

Keywords

OverweightObesityExerciseWeight Loss

Outcome Measures

Primary Outcomes (2)

  • Prevention of Weight Regain

    To compare the effectiveness of 3 exercise recommendations on the prevention of weight regain over 12 mos. subsequent to clinically significant weight loss (\> 5%). We expect participants will regain weight in a dose-response manner, i.e. greatest, intermediate and least weight regain for the 150, 225, and 300 minute. groups, respectively.

    12 Months

  • Gender Differences in Weight Regain

    To evaluate gender differences in weight regain over 12 months in response to 3 exercise recommendations. Based on available preliminary data we expect men will regain less weight than women.

    12 Months

Secondary Outcomes (1)

  • Compensatory Changes to three exercise levels

    12 Months

Study Arms (3)

150 Minutes per Week

ACTIVE COMPARATOR

Performs 150 minutes of physical activity per week.

Behavioral: 150 Min/Week

225 Minutes per Week

ACTIVE COMPARATOR

Performs 225 minutes of physical activity per week.

Behavioral: 225 Min/Week

300 Minutes per Week

ACTIVE COMPARATOR

Performs 300 minutes of physical activity per week.

Behavioral: 300 Min/Week

Interventions

150 Min/WeekBEHAVIORAL

Performs 150 min/wk of planned moderate intensity aerobic exercise.

150 Minutes per Week
225 Min/WeekBEHAVIORAL

Performs 225 min/wk of planned moderate intensity aerobic exercise.

225 Minutes per Week
300 Min/WeekBEHAVIORAL

Performs 300 min/wk of planned moderate intensity aerobic exercise.

300 Minutes per Week

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21 to 55 years.
  • BMI of 25 to 45.0.
  • Clearance for participation from their Primary Care Physician (PCP)

You may not qualify if:

  • Participation in a research project involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
  • Participation in a regular exercise program (i.e., \> 500 kcal/wk. of planned activity as estimated by questionnaire)
  • Not weight stable (+ or - 4.5 kg) for 3 mos. prior to intake.
  • Unwilling to be randomized to 1 of 3 exercise groups subsequent to weight loss.
  • Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 15 mos.
  • Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e., heart attack, angioplasty, etc.). This is determined by the individual's physician via the clearance to participate in the investigation and the health history (Appendix) interpreted by the staff physician.
  • Eating disorders as determined by the Eating Attitudes Test using a score of 20 or greater
  • Current treatment for psychological problems, or taking psychotropic medications
  • Medications known to significantly affect weight (gain or loss).
  • Adherence to specialized diet regimens, i.e., multiple food allergies, vegetarian, macrobiotic, etc.
  • Do not have access to grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas - Robinson Hall

Lawrence, Kansas, 66045, United States

Location

Related Publications (3)

  • Kracht CL, Brown DMY, Gorczyca AM, Jakicic JM, Szabo-Reed A, Washburn R, Donnelly JE. Association Between Wake-Time Movement Behaviors and Weight Loss Maintenance. Obesity (Silver Spring). 2025 Nov 16:10.1002/oby.70082. doi: 10.1002/oby.70082. Online ahead of print.

    PMID: 41243427DERIVED

  • Szabo-Reed AN, Martin LE, Savage CR, Washburn RA, Donnelly JE. Pre-post intervention exploring cognitive function and relationships with weight loss, intervention adherence and dropout. Health Psychol Behav Med. 2023 Jan 6;11(1):2162528. doi: 10.1080/21642850.2022.2162528. eCollection 2023.

    PMID: 36632603DERIVED

  • Szabo AN, Washburn RA, Sullivan DK, Honas JJ, Mayo MS, Goetz J, Lee J, Donnelly JE. The Midwest Exercise Trial for the Prevention of Weight Regain: MET POWeR. Contemp Clin Trials. 2013 Nov;36(2):470-8. doi: 10.1016/j.cct.2013.08.011. Epub 2013 Sep 4.

    PMID: 24012915DERIVED

MeSH Terms

Conditions

OverweightObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Joseph Donnelly, EdD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2018

Study Completion

December 31, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

US(1)