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Bright Light Therapy for Weight Loss

This study has been completed.

Sponsored by: Russian Academy of Medical Sciences
Information provided by: Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00406770
  Purpose

The study investigates whether bright artificial light adds to hypocaloric diet to lose weight in obese patients.


Condition Intervention
Obesity
Procedure: Light therapy

MedlinePlus related topics:   Obesity    Weight Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • weight, kg

Enrollment:   41
Study Start Date:   December 2006
Study Completion Date:   April 2007

Detailed Description:

The study is aimed to check a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvey, 2002, unpublished). Subjects: ageg 20-65 y, BMI > 30, non-seasonal (SPAQ score <8, no seasonal problem), in good general health, with regular sleep from 22:00-1:00 to 6:00-9:00. Study season: November-April. Placebo-controlled, single-blind, crossover. At least 1 mo between two arms; at similar phase of menstrual cycle (if present). If could not complete at the first year, the second arm is to be done the next winter. Intervention: for 3 weeks each morning (at least 18 days) starting between 6:00-9:00. Seating, distance between the face and device is 41 cm, for 30 min. Lightbox - during one arm, deactivated ioniser - during another arm, in alternated order. Diet: a target amount of kcal per day is calculated based on age, weight and gender (WHO), e.g. for a woman 40 y ang 80 kg it is 1502 kcal per day. Food content - is also as recommended by WHO. Food distribution over day - usual for the particular test subject but constant over sessions. Food diary is completed daily and subjects calculate kcal themselves based on a Table of kcal. Outcomes: Weight is measured a day before and day after the 3-week session, during a visit to doctor, and also at home every week (to get a dynamic). Motivation and Expectation are rated by 3-point scales, in a Diary, at the beginning of each session. A general feeling (mood, activity, and appetite) - by a VAS-like 10-points scale every week. At the end of each arm the "Easiness of dieting" scale and Adverse event(s) are completed. In the diary, there are also columns for sleep on - off times, intervention time, duration, and distance, number of kcal. A total number of subjects to complete the study is 40.

  Eligibility
Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • age 20-65 y
  • BMI > 30
  • non-seasonal (SPAQ score <8, no seasonal problem)
  • good general health; if there is a serious chronic disease - then compensated, with a constant dose of medication(s)
  • regular sleep from 22:00-1:00 to 6:00-9:00
  • a wish to participate and complete the study

Exclusion Criteria:

  • any acute disease during the past month
  • transmeridian travel >3 time zones over the past month
  • a use of medication(s) which influence body weight - during the last 2 months
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406770

Locations
Russian Federation
Institute of Internal Medicine SB RAMS    
      Novosibirsk, Russian Federation, 630089

Sponsors and Collaborators
Russian Academy of Medical Sciences

Investigators
Principal Investigator:     Konstantin V. Danilenko, MD     Institute of Internal Medicine SB RAMS    
  More Information


Study ID Numbers:   We-Light
First Received:   November 30, 2006
Last Updated:   July 13, 2007
ClinicalTrials.gov Identifier:   NCT00406770
Health Authority:   Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Russian Academy of Medical Sciences:
Obesity  
Light therapy  
Hypocaloric diet  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on October 20, 2008




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