The Comparison of Energy in Take and Body Weight EXERCISE

NCT01264406 | Completed Results

• 1 other identifier: PBRC 10008
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exercise; Energy; Body Weight

Outcome Measures

Primary Outcomes (1)

• A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW]

  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.

  6 months after screening

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (4)

• Dorling JL, Hochsmann C, Fearnbach SN, Apolzan JW, Hsia DS, Johannsen NM, Church TS, Martin CK. Initial Weight Change and Long-Term Changes in Weight and Compensation during Supervised Exercise Training. Med Sci Sports Exerc. 2021 Aug 1;53(8):1675-1684. doi: 10.1249/MSS.0000000000002633.

  PMID: 33731664 DERIVED

• Martin CK, Johnson WD, Myers CA, Apolzan JW, Earnest CP, Thomas DM, Rood JC, Johannsen NM, Tudor-Locke C, Harris M, Hsia DS, Church TS. Effect of different doses of supervised exercise on food intake, metabolism, and non-exercise physical activity: The E-MECHANIC randomized controlled trial. Am J Clin Nutr. 2019 Sep 1;110(3):583-592. doi: 10.1093/ajcn/nqz054.

  PMID: 31172175 DERIVED

• Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.

  PMID: 29437573 DERIVED

• 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.

  PMID: 24906459 DERIVED

MeSH Terms

Conditions

Motor Activity; Body Weight

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Corby Martin
• Organization: Pennington Biomedical Research Center

corby.martin@pbrc.edu

763-2585

Study Officials

• Corby Martin, PhD

  PBRC

  PRINCIPAL INVESTIGATOR

• Timothy Church, MD; MPH; PhD

  PBRC Co-Principal Investigator

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 7, 2025
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Locations

US (1)