NCT01664715

A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight
• Obesity
• Weight Loss

Interventions

Type	Name	Description
BEHAVIORAL	150 Min/Week	Performs 150 min/wk of planned moderate intensity aerobic exercise.
BEHAVIORAL	225 Min/Week	Performs 225 min/wk of planned moderate intensity aerobic exercise.
BEHAVIORAL	300 Min/Week	Performs 300 min/wk of planned moderate intensity aerobic exercise.

Timeline

• Start date: 2012-08-01
• Primary completion: 2018-04-01
• Completion: 2018-12-31
• First posted: 2012-08-14
• Last updated: 2019-04-18

Locations

1 site across 1 country: United States