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A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain

This study is not yet open for participant recruitment.
Verified August 2012 by University of Kansas
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01664715
First received: August 10, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels of recommended energy expenditure of exercise (EEEx) 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 EEEx (1,000 kcal/wk.), a level of exercise consistent with Health and Human Services (HHS) recommendations. Participants achieving clinically significant weight loss (> 5% of initial weight), will be randomly assigned to 12 mos. of exercise at levels of EEEx recommended by: 1.) HHS, ~1,000 kcal/wk., 2.) American College of Sports Medicine( ACSM),~ 2,000 kcal/wk., 3.) Institute of Medicine (IOM), ~3,000 kcal/wk. 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: 1,000 kcal/wk
Behavioral: 2,000 kcal/wk
Behavioral: 3,000 kcal/wk

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:

U.S. FDA Resources

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 1,000, 2,000 and 3,000 kcal/wk. 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 ]
    To evaluate 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: 1,000 kcal/wk
Performs 1,000 kcal/wk of planned moderate intensity aerobic exercise.
 Behavioral: 1,000 kcal/wk
Performs 1,000 kcal/wk of planned moderate intensity aerobic exercise.
Active Comparator: 2,000 kcal/wk
Performs 2,000 kcal/wk of planned moderate intensity aerobic exercise.
 Behavioral: 2,000 kcal/wk
Performs 2,000 kcal/wk of planned moderate intensity aerobic exercise.
Active Comparator: 3,000 kcal/wk
Performs 3,000 kcal/wk of planned moderate intensity aerobic exercise.
 Behavioral: 3,000 kcal/wk
Performs 3,000 kcal/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 (1,000 kcal/wk.) will be randomly assigned to either maintain exercise at 1,000 kcal/wk. or increase exercise to 2,000 or 3,000 kcal/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 3 mo. intervals beginning at mo. 0 (the end of weight loss). 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 39.9.
  • Clearance for participation from their 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664715

Contacts
Contact: Jeff Honas 785-864-4163 jhonas@ku.edu

Locations
United States, Kansas
University of Kansas - Robinson Hall Not yet recruiting
Lawrence, Kansas, United States, 66045
Contact: Jeff Honas     785-864-4163        
Sponsors and Collaborators
University of Kansas
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Joseph Donnelly, EdD University of Kansas
  More Information

No publications provided

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: August 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013