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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL111842 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 Minutes per Week | Active Comparator | Performs 150 minutes of physical activity per week. |
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| 225 Minutes per Week | Active Comparator | Performs 225 minutes of physical activity per week. |
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| 300 Minutes per Week | Active Comparator | Performs 300 minutes of physical activity per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 150 Min/Week | Behavioral | Performs 150 min/wk of planned moderate intensity aerobic exercise. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Donnelly, EdD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas - Robinson Hall | Lawrence | Kansas | 66045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41243427 | Derived | 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. | |
| 36632603 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 225 Min/Week | Behavioral | Performs 225 min/wk of planned moderate intensity aerobic exercise. |
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| 300 Min/Week | Behavioral | Performs 300 min/wk of planned moderate intensity aerobic exercise. |
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| 24012915 | Derived | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |