OverweightPOWeRNCT01664715
A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain
A study testing 150 Min/Week, 225 Min/Week and 300 Min/Week in people with Overweight and Obesity, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Overweight, Obesity, Weight Loss
- What is being tested?
- 150 Min/Week, 225 Min/Week and 300 Min/Week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 31 Dec 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 55 years.
- BMI of 25 to 45.0.
- Clearance for participation from their Primary Care Physician (PCP)
Who cannot join
- 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.
Show all 11Show fewer
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas - Robinson Hall
Lawrence, Kansas, 66045
About this study
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.).
Read the 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.
- Conditions
- Overweight, Obesity, Weight Loss
- Being tested
- 150 Min/Week, 225 Min/Week, 300 Min/Week
- Keywords
- Overweight, Obesity, Exercise, Weight Loss
- Medical subject headings
- Overweight, Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 Min/WeekBehavioural
Performs 150 min/wk of planned moderate intensity aerobic exercise.
225 Min/WeekBehavioural
Performs 225 min/wk of planned moderate intensity aerobic exercise.
300 Min/WeekBehavioural
Performs 300 min/wk of planned moderate intensity aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| 150 Minutes per Week | Active comparator | Performs 150 minutes of physical activity per week. Receives: Behavioral: 150 Min/Week |
| 225 Minutes per Week | Active comparator | Performs 225 minutes of physical activity per week. Receives: Behavioral: 225 Min/Week |
| 300 Minutes per Week | Active comparator | Performs 300 minutes of physical activity per week. Receives: Behavioral: 300 Min/Week |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion1 Apr 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas
- Investigators
- Joseph Donnelly, EdD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664715
- Sponsor's protocol ID
- HSCL19775
- Other IDs
- R01HL111842
- Acronym
- POWeR
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2012
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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). 2026 Feb;34(2):472-481. doi: 10.1002/oby.70082. Epub 2025 Nov 16.
PubMed 41243427Szabo-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.
PubMed 36632603Szabo 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.
PubMed 24012915
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain
- ClinicalTrials.gov ID
- NCT01664715
- Acronym / sponsor ID
- POWeR / HSCL19775
- Conditions
- Overweight, Obesity, Weight Loss
- Keywords
- Overweight, Obesity, Exercise, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2012 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Aug 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 Minutes per Week | Active comparator | Behavioral: 150 Min/WeekPerforms 150 minutes of physical activity per week. |
| 225 Minutes per Week | Active comparator | Behavioral: 225 Min/WeekPerforms 225 minutes of physical activity per week. |
| 300 Minutes per Week | Active comparator | Behavioral: 300 Min/WeekPerforms 300 minutes of physical activity per week. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21 to 55 years.
- BMI of 25 to 45.0.
- Clearance for participation from their Primary Care Physician (PCP)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 Min/WeekPerforms 150 min/wk of planned moderate intensity aerobic exercise. | Behavioural | 150 Minutes per Week |
| 225 Min/WeekPerforms 225 min/wk of planned moderate intensity aerobic exercise. | Behavioural | 225 Minutes per Week |
| 300 Min/WeekPerforms 300 min/wk of planned moderate intensity aerobic exercise. | Behavioural | 300 Minutes per Week |
Primary outcome
Prevention of Weight Regain
Time frame: 12 Months
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
Time frame: 12 Months
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.
1 secondary outcome
Compensatory Changes to three exercise levels
Time frame: 12 Months
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 18 Apr 2019.
- Derived from this study: PubMed 41243427Kracht 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). 2026 Feb;34(2):472-481. doi: 10.1002/oby.70082. Epub 2025 Nov 16.
- Derived from this study: PubMed 36632603Szabo-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.
- Derived from this study: PubMed 24012915Szabo 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.
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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.
Joseph Donnelly, EdD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 150 Min/Week, 225 Min/Week and 300 Min/Week in people with Overweight and Obesity, run by University of Kansas 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?
The sponsor lists 3 inclusion and 11 exclusion criteria. 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 18 Apr 2019. 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?
Prevention of Weight Regain (time frame: 12 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 NCT01664715, which also lists 3 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 18 Apr 2019.