The Comparison of Energy in Take and Body Weight EXERCISE (E-MECHANIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01264406
First received: December 20, 2010
Last updated: May 16, 2014
Last verified: May 2014

December 20, 2010
May 16, 2014
December 2010
June 2014   (final data collection date for primary outcome measure)
A Comparison of the effects of energy balance with three groups. [ Time Frame: 6 months after screening ] [ Designated as safety issue: No ]

A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance.

Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study.

Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill.

High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.

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Complete list of historical versions of study NCT01264406 on ClinicalTrials.gov Archive Site
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The Comparison of Energy in Take and Body Weight EXERCISE
Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation

This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. E-Mechanic trial can make important contributions to understanding of the role of exercise dose in weight management. While it is accepted that regular exercise plays an important role in general health, the exact role of exercise in prevention of weight gain, weight loss and prevention of weight regain remains poorly understood despite exercise being widely prescribed for these purposes. The idea that current weight management exercise recommendations may produce increased energy intake (or other forms on compensation) resulting in disappointing weight loss is an important public health issue. The finding of this study could help shape future exercise and weight loss recommendations and treatment plans.

The purpose of the E-MECHANIC Trial is to test the effect of two doses of exercise on energy intake, body weight, body composition, activity levels, and metabolic rate. The exercise doses will reflect current recommendations for: 1) general health (8 KKW), and 2) weight loss (20 KKW). A non-exercise control group will also be recruited. The primary outcome variables are: 1) energy intake, and 2) the discrepancy between expected weight loss and observed weight loss. Energy intake will be measured using doubly labeled water and laboratory-based food intake tests. Secondary outcome variables include resting metabolic rate, activity levels (excluding structured exercise), and body composition. Following a comprehensive baseline assessment, participants will be randomly assigned to the 8 KKW, 20 KKW, or control group in a 1:1:1 ratio. Additional assessments will be conducted at week 4, with another comprehensive assessment at week 24. The week 4 assessment is important to determine if endpoints change in the short-term, but not long-term.

Observational
Observational Model: Case Control
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Probability Sample

The study population group will be 198 sedentary, overweight and obese(BMI levels > 25 kg/m2 and < 40 kg/m2) individuals. Based on previous studies, we expect to enroll 132 females and 66 males. Participants will be randomly assigned to an 8 kcal/kg/week, 20 kcal/kg/week, or control group. The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory.

  • Exercise
  • Energy
  • Body Weight
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  • Exercise Group (20 KKW)
    Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
  • Exercise Group (8 KKW)
    One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
  • Control group
    This group will be instructed to maintain their baseline level of exercise.
Myers CA, Johnson WD, Earnest CP, Rood JC, Tudor-Locke C, Johannsen NM, Cocreham S, Harris M, Church TS, Martin CK. Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial. Trials. 2014 Jun 7;15:212. doi: 10.1186/1745-6215-15-212.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
198
June 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female 18 - 65 years old, inclusive

    • Not exercising > 20 minutes on > 3 days/wk and taking < 8000 steps/d over one week measured with step counters.
    • BMI > 25 kg/m2 and < 40 kg/m2

Exclusion Criteria:

  • • Current consumption of more than 14 alcoholic drinks per week

    • Plan to move out of the study area within the next 6 months or plan to be out of the study area for more than 4 weeks in the next 6 months
    • Have another member of household participating in the study
    • Residence too far from Pennington
    • A past history and/or physical examination or laboratory findings of the following medical conditions:

Table 1. Exclusion Criteria

  • Cardiovascular disease (CVD) or disorders Potential participants with a history of CVD
  • Blood Pressure Potential participants who are on a stable dose of antihypertensive medication, with the exception of beta-blockers, and whose blood pressure is controlled will be eligible for enrollment.
  • Diabetes Potential participants with a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose >125 mg/dl will be excluded from the study.
  • Blood lipids Potential participants whose LDL-C 190 mg/dl or TG levels 300 mg/dl will be referred to their physician.
  • Hematologic disorders Participants diagnosed with hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states, will not be allowed into the study.
  • Recent blood donation or blood loss Blood donation or blood loss from surgery or trauma during the 6 weeks before the baseline evaluation
  • Weight loss-20 or more kilograms in the past year Other exclusions.
  • Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness. Plans to be out of the city more than 4 weeks over the next 6 months
  • Other significant medical conditions Including but not limited to chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. Musculoskeletal problems interfering with exercise.
  • Autoimmune or collagen vascular diseases. Immunodeficiency diseases or a positive HIV test. Malignancies in the past 5 years, with the exception of non-melanoma skin cancer therapeutically controlled. Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
Both
18 Years to 65 Years
Yes
Contact: Grace Bella 225-763-3000 Grace.Bella@pbrc.edu
United States
 
NCT01264406
PBRC10008
No
Corby K. Martin, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Principal Investigator: Corby Martin, PhD PBRC
Principal Investigator: Timothy Church, MD; MPH; PhD PBRC Co-Principal Investigator
Study Chair: Conrad Earnest, PhD PBRC Co-Investigator
Study Chair: Catrine Tudor-Locke, PhD PBRC Co-Investigator
Study Chair: William Johnson, PhD PBRC Co-Investigator
Study Chair: Jennifer Rood, PhD PBRC Co-Investigator
Pennington Biomedical Research Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP