A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Kansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01664715
First received: August 10, 2012
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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.).


Condition Intervention
Overweight
Obesity
Weight Loss
Behavioral: 150 Min/Week
Behavioral: 225 Min/Week
Behavioral: 300 Min/Week

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Prevention of Weight Regain [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 287
Study Start Date: August 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 150 Minutes per Week
Performs 150 minutes of physical activity per week.
Behavioral: 150 Min/Week
Performs 150 min/wk of planned moderate intensity aerobic exercise.
Active Comparator: 225 Minutes per Week
Performs 225 minutes of physical activity per week.
Behavioral: 225 Min/Week
Performs 225 min/wk of planned moderate intensity aerobic exercise.
Active Comparator: 300 Minutes per Week
Performs 300 minutes of physical activity per week.
Behavioral: 300 Min/Week
Performs 300 min/wk of planned moderate intensity aerobic exercise.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664715

Contacts
Contact: Lisa Haney, MS, RD, LD 785-864-3770 lhaney2@kumc.edu

Locations
United States, Kansas
University of Kansas - Robinson Hall Recruiting
Lawrence, Kansas, United States, 66045
Contact: Lisa Haney       lhaney3@kumc.edu   
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Joseph Donnelly, EdD University of Kansas
  More Information

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Donnelly, Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01664715     History of Changes
Other Study ID Numbers: HSCL19775, R01HL111842
Study First Received: August 10, 2012
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Overweight
Obesity
Exercise
Weight Loss

Additional relevant MeSH terms:
Body Weight
Overweight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 27, 2015