Short Term Effects of Increasing Sleep Duration

August 29, 2016 updated by: Rena R. Wing, The Miriam Hospital

Increasing Sleep Duration: A Novel Approach to Weight Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control & Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.
Behavioral: No change in sleep
This group is taught to maintain their current sleep habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Duration
Time Frame: 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.
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Investigators

  • Principal Investigator: Rena R. Wing, PhD, The Miriam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01CA150387 - Study 2
  • U01CA150387 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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