Short Term Effects of Increasing Sleep Duration

Phase 2

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Sleep Duration; Behavioral: No change in sleep

• Registration Number: NCT01428687
• Lead Sponsor: The Miriam Hospital

Brief Summary

A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.

Detailed Description

Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.

Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.

Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age 25 to 45;
• BMI 25 to 50;
• healthy;
• sleep 6.5 hours or less per night

Exclusion Criteria

• use of sleep medications;
• sleep apnea;
• third shift worker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Increase Sleep Gradually	Sleep Duration	Subjects in this condition are taught to increase their sleep by 30 minutes per night during week 1 of the intervention; 60 minutes during week 2; and 90 minutes during week 3. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.
Increase Sleep Immediately	Sleep Duration	Subjects in this condition are taught to increase their sleep by 90 minutes per night starting in week 1. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.
No Intervention: Control Group	No change in sleep	This group is told to make no changes in their sleep habits. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.

Primary Outcome Measures

Name	Time	Method
Sleep Duration	4 weeks	Participants with verified short sleep are taught to increase their sleep either gradually or immediately. These two groups are compared to a control group who makes no changes in their sleep. The primary outcome is sleep duration per night as determined by actigraphy.

Secondary Outcome Measures

Name	Time	Method
Eating Behavior	4 weeks	24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.
Physical Activity	4 weeks	Objective measures of physical activity are obtained before and after the 4-week sleep intervention.

Trial Locations

Locations (1)

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