Short Term Effects of Increasing Sleep Duration

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Overweight and Obesity
Behavioral: Sleep Duration
Behavioral: No change in sleep
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increasing Sleep Duration: A Novel Approach to Weight Control

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428687

Contacts
Contact: Rena R. Wing, PhD 401-793-8959 rwing@lifespan.org

Locations
United States, Rhode Island
Weight Control & Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Rena R. Wing, PhD    401-793-8959    rwing@lifespan.org   
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Rena R. Wing, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: Rena R. Wing, Professor of Psychiatry and Human Behavior, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01428687     History of Changes
Other Study ID Numbers: U01CA150387 - Study 2
Study First Received: September 1, 2011
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Weight loss
Sleep duration

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014