跳至主要内容
临床试验/NCT00406770
NCT00406770已完成不适用

Bright Light Therapy for Weight Loss

Russian Academy of Medical Sciences0 个研究点目标入组 41 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
主要终点
weight, kg

研究概览

简要总结

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

详细描述

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a preliminary evidence that bright light may help to lose weight in obese people (Thor Helge Bergan, Norvay, 2002, unpublished).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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

weight, kg

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other

相似试验

Bright Light Therapy for Weight Loss | 临床试验