NCT00384345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

October 6, 2006

Status Verified

July 1, 2006

First QC Date

October 4, 2006

Last Update Submit

October 4, 2006

Conditions

Keywords

bright light treatmentexercisebody fat indexmoodsleepfatigue

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure will be the amount of weight loss.

Secondary Outcomes (1)

  • Secondary outcome measures will be the ratings of mood on the POMS, CES-D and SPAQ

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

ObesityFatigueMotor Activity

Interventions

Ultraviolet TherapyExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

PhototherapyTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Colin M. Shapiro, MBBCh, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

September 1, 2003

Study Completion

December 1, 2003

Last Updated

October 6, 2006

Record last verified: 2006-07

Locations