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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01264406
First received: December 20, 2010
Last updated: February 3, 2016
Last verified: February 2016
History of Changes
  Purpose
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.

Condition
Exercise
Energy
Body Weight

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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.
Enrollment: 198
Study Start Date: December 2010
Study Completion Date: December 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
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.
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
  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: NCT01264406

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Corby K. Martin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01264406     History of Changes
Other Study ID Numbers: PBRC 10008 
Study First Received: December 20, 2010
Last Updated: February 3, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016