N/A
N=198
The Comparison of Energy in Take and Body Weight EXERCISE
Exercise · Energy · Body Weight
Bottom Line
View on ClinicalTrials.gov: NCT01264406 ↗Enrolled (actual)
198
Serious AEs
3.0%
Results posted
Dec 2024
Primary outcome: Primary: A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] — 123.6; 90.7; -2.3 kcal/day
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW] |
123.6; 90.7; -2.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female 18 - 65 years old, inclusive
- Not exercising > 20 minutes on > 3 days/wk and taking 25 kg/m2 and 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
Data sourced from ClinicalTrials.gov (NCT01264406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.