- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384345
Exercise and Bright Light Treatment: Effects on Body Weight and Composition
Moderate Exercise and Bright Light Treatment in Overweight Individuals
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective: Increased physical activity is important given the concern over the growing rates of obesity. Bright light therapy has the potential to enhancing serotonin levels, impact on carbohydrate metabolism and reducing soreness and hyperthermia associated with physical activity. The aim of this study is to conduct a controlled investigation of the effects of bright light therapy and exercise on weight loss and body composition in overweight individuals.
Research Methods and Procedures: Twenty-five overweight male and female subjects will be assigned to 6 weeks of moderate exercise with or without bright light treatment. Outcome measure included changes in body mass and body composition and ratings of mood, seasonality and sleep.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overweight subjects
- Subjects in otherwise good health
- Subjects willing to participate in a 6-week moderate exercise program
- Bedtime between 10pm and 12am; wake-up time between 6am and 8am
- Score in the median range of the Morningness/ Eveningness Questionnaire (i.e., subjects show no distinct characteristics of phase delay or phase advance)
Exclusion Criteria:
- Progressive eye disease
- History of cataracts, macular degeneration or have undergone laser corrective eye surgery in the past 30 days.
- Currently taking any medications, e.g. antibiotics, tricyclic antidepressants, that may affect photosensitivity
- History of heart disease
- History of respiratory diseases, such as asthma, emphysema
- Any severe or uncontrolled general medical condition
- Severe psychiatric disorder (as determined by psychiatrist - CMS)
- History of mania
- Grossly obese individuals with morbid obesity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome measure will be the amount of weight loss.
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Secondary Outcome Measures
Outcome Measure |
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Secondary outcome measures will be the ratings of mood on the POMS, CES-D and SPAQ
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-0184-BE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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