Bright Light Therapy for Weight Loss

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406770
• Other study ID #: We-Light
• Status: Completed
• Phase: N/A
• First received: November 30, 2006
• Last updated: October 18, 2009
• Start date: December 2006
• Est. completion date: April 2007

Study information

• Verified date: October 2009
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvay, 2002, unpublished).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Light therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight, kg		4 months	No