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A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain (POWeR)

Primary Purpose

Overweight, Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

150 Min/Week

225 Min/Week

300 Min/Week

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Exercise, Weight Loss

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.).

Sites / Locations

University of Kansas - Robinson Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

150 Minutes per Week

225 Minutes per Week

300 Minutes per Week

Arm Description

Performs 150 minutes of physical activity per week.

Performs 225 minutes of physical activity per week.

Performs 300 minutes of physical activity per week.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Compensatory Changes to three exercise levels

Evaluating the impact of potential compensatory changes in daily physical activity and energy intake on weight regain in response to 3 exercise recommendations. Any observed compensatory responses would inform the development of subsequent targeted interventions.

Full Information

NCT ID

NCT01664715

First Posted

August 10, 2012

Last Updated

April 16, 2019

Sponsor

University of Kansas

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01664715

Brief Title

A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

Acronym

POWeR

Official Title

A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2012 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.).

Detailed Description

The investigators propose a randomized trial in 287 overweight and obese, sedentary adults (at least 50% women). Participants achieving clinically significant weight loss (≥5%) following a 3 mo. reduced energy diet and a program of PA (100 min/wk) will be randomly assigned to either maintain exercise at 150 min/wk. or increase exercise to 225 min/wk or 300 min/wk. while consuming a weight gain prevention diet over a 12 mo. period. Exercise will be verified (combination of on-site and HR monitor) and EEEx will be measured at 5 mo. intervals beginning at mo. 5. In-person behaviorally based clinic meetings will be conducted weekly during the 3 mo. weight loss period (-3 to 0 mos.) and during the first 3 mos. of the weight regain prevention period. During the final 9 mos. of weight regain prevention, clinics will be held bi-monthly using group conference calls. We have not proposed to randomize participants to a true control group (i.e. no exercise or diet) following the 3 mo. weight loss program as published data indicates significant weight regain in individuals receiving no follow-up treatment after weight loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Weight Loss

Keywords

Overweight, Obesity, Exercise, Weight Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

287 (Actual)

8. Arms, Groups, and Interventions

Arm Title

150 Minutes per Week

Arm Type

Active Comparator

Arm Description

Performs 150 minutes of physical activity per week.

Arm Title

225 Minutes per Week

Arm Type

Active Comparator

Arm Description

Performs 225 minutes of physical activity per week.

Arm Title

300 Minutes per Week

Arm Type

Active Comparator

Arm Description

Performs 300 minutes of physical activity per week.

Intervention Type

Behavioral

Intervention Name(s)

150 Min/Week

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

225 Min/Week

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

300 Min/Week

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevention of Weight Regain

Description

Time Frame

12 Months

Title

Gender Differences in Weight Regain

Description

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.

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Compensatory Changes to three exercise levels

Description

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Donnelly, EdD

Organizational Affiliation

University of Kansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas - Robinson Hall

City

Lawrence

State/Province

Kansas

ZIP/Postal Code

66045

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24012915

Citation

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.

Results Reference

derived

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A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

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