NCT00406770

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable obesity

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

November 30, 2006

Last Update Submit

October 18, 2009

Conditions

Obesity

Keywords

ObesityLight therapyHypocaloric diet

Outcome Measures

Primary Outcomes (1)

  • weight, kg

    4 months

Interventions

Light therapyDEVICE

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Danilenko KV, Mustafina SV, Pechenkina EA. Bright light for weight loss: results of a controlled crossover trial. Obes Facts. 2013;6(1):28-38. doi: 10.1159/000348549. Epub 2013 Feb 21.

    PMID: 23429094DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Konstantin V. Danilenko, MD

    Institute of Internal Medicine SB RAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

December 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

October 19, 2009

Record last verified: 2009-10