Overview

This trial is active, not recruiting.

Condition overweight and obesity
Treatments weight loss education, sleep and eating routine
Phase phase 2
Sponsor The Miriam Hospital
Start date October 2012
End date August 2016
Trial size 90 participants
Trial identifier NCT01717352, U01CA150387-Study 5

Summary

The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
weight loss education
(Active Comparator)
Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
sleep and eating routine

Primary Outcomes

Measure
Weight
time frame: 20 weeks

Secondary Outcomes

Measure
Executive Control
time frame: 4 and 20 weeks

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: - age 21 to 65 - BMI 25 to 45 - sleep 7 hours or less most nights Exclusion Criteria: - use of medications affecting sleep - sleep apnea - shift work

Additional Information

Official title Increasing Sleep Duration: A Novel Approach to Weight Control. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss
Principal investigator Rena R Wing, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by The Miriam Hospital.