Back to resultsExercise and Bright Light Treatment: Effects on Body Weight and Composition
Primary Purpose
Obesity, Fatigue
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Bright Light Therapy
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring bright light treatment, exercise, body fat index, mood, sleep, fatigue
Eligibility Criteria
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
Sites / Locations
- University Health Network
Outcomes
Primary Outcome Measures
The primary outcome measure will be the amount of weight loss.
Secondary Outcome Measures
Secondary outcome measures will be the ratings of mood on the POMS, CES-D and SPAQ
Full Information
NCT ID
NCT00384345
First Posted
October 4, 2006
Last Updated
October 4, 2006
Sponsor
University Health Network, Toronto
Collaborators
The Litebook Company Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00384345
Brief Title
Exercise and Bright Light Treatment: Effects on Body Weight and Composition
Official Title
Moderate Exercise and Bright Light Treatment in Overweight Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Litebook Company Ltd.
4. Oversight
5. Study Description
Brief Summary
Bright light therapy has been used to safely and effectively treat conditions such as Seasonal Affective Disorder and to regularize sleep in patients with circadian rhythm disorder. Based on evidence of the link between bright light, serotonin, mood and carbohydrate metabolism, it has been suggested that bright light therapy can improve weight loss but the literature on the subject is sparse. Further, the literature suggests that apart from any changes in mood and carbohydrate metabolism, bright light may reduce the unpleasant side-effects of exercise and increase compliance to an exercise program.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Fatigue
Keywords
bright light treatment, exercise, body fat index, mood, sleep, fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Bright Light Therapy
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
The primary outcome measure will be the amount of weight loss.
Secondary Outcome Measure Information:
Title
Secondary outcome measures will be the ratings of mood on the POMS, CES-D and SPAQ
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin M. Shapiro, MBBCh, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
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Exercise and Bright Light Treatment: Effects on Body Weight and Composition
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