A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

Completed · Not applicable

Conditions studied: Overweight, Obesity, Weight Loss

In brief

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.).

Key facts

Study ID

NCT01664715

Run by

University of Kansas

People needed

287

Starts

2012-08-01

Expected to finish

2018-12-31

Last updated by the study team

2019-04-18

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.).

Where it is running

• University of Kansas - Robinson Hall — Lawrence, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.