Sleep Plus Eating Routines for Weight Loss

Phase 2

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Sleep and Eating Routine; Behavioral: Weight Loss Education

• Registration Number: NCT01717352
• Lead Sponsor: The Miriam Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep and Eating Routine	Sleep and Eating Routine	Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
Weight Loss Education	Weight Loss Education	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.

Primary Outcome Measures

Name	Time	Method
Weight	20 weeks

Secondary Outcome Measures

Name	Time	Method
Executive Control	4 and 20 weeks	Executive control is measured by a variety of computer assessments. These include Go-No Go, delayed discounting, and perseverence as measured by mirror tracing and a hand grip task.

Trial Locations

Locations (1)

Weight Control & Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States