Bright Light Therapy for Weight Loss

This study has been completed.
Sponsor:
Information provided by:
Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00406770
First received: November 30, 2006
Last updated: October 18, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention
Obesity
Device: Light therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • weight, kg [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvay, 2002, unpublished). Subjects: aged 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: Lightbox (4300 lux) - during one arm, deactivated ioniser - during another arm (sequential alternation upon entering the study) for 3 weeks each morning (at least 18 days) starting between 6:00-9:00. Seating distance (from the face to the device) is 41 cm, duration - 30 min. 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 during a visit to doctor a day before and day after the 3-week session, and also at home every week. Motivation and Expectation are rated by 3-point scales in a Diary, at the beginning of each session. Mood, activity and appetite are self-estimated using 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 and off times, intervention time, duration and distance, number of kcal. A target 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Principal Investigator: Konstantin V. Danilenko, MD Institute of Internal Medicine SB RAMS
  More Information

No publications provided by Russian Academy of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Outside In
ClinicalTrials.gov Identifier: NCT00406770     History of Changes
Other Study ID Numbers: We-Light
Study First Received: November 30, 2006
Last Updated: October 18, 2009
Health Authority: Russia: Ethics Committee

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014