Short Term Effects of Increasing Sleep Duration

This study is currently recruiting participants.

Verified April 2013 by The Miriam Hospital

Sponsor:

Information provided by (Responsible Party):

Rena R. Wing, The Miriam Hospital

ClinicalTrials.gov Identifier:

NCT01428687

First received: September 1, 2011

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2011

Last Updated Date

April 23, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sleep Duration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01428687 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Eating Behavior [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.
Physical Activity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Objective measures of physical activity are obtained before and after the 4-week sleep intervention.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Short Term Effects of Increasing Sleep Duration

Official Title ^ICMJE

Increasing Sleep Duration: A Novel Approach to Weight Control

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Overweight and Obesity

Intervention ^ICMJE

Behavioral: Sleep Duration
Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.
Behavioral: No change in sleep
This group is taught to maintain their current sleep habits.

Study Arm (s)

Active Comparator: Increase Sleep Gradually
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.

Intervention: Behavioral: Sleep Duration
Active Comparator: Increase Sleep Immediately
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.

Intervention: Behavioral: Sleep Duration
Active Comparator: No Intervention: Control Group
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.

Intervention: Behavioral: No change in sleep

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2016

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Rena R. Wing, PhD

401-793-8959

rwing@lifespan.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01428687

Other Study ID Numbers ^ICMJE

U01CA150387 - Study 2

Has Data Monitoring Committee

Responsible Party

Rena R. Wing, The Miriam Hospital

Study Sponsor ^ICMJE

The Miriam Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rena R. Wing, PhD

The Miriam Hospital

Information Provided By

The Miriam Hospital

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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