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

September 1, 2011
July 7, 2014
August 2011
August 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01428687 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Short Term Effects of Increasing Sleep Duration
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 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Overweight and Obesity
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
25 Years to 45 Years
Yes
Contact: Rena R. Wing, PhD 401-793-8959 rwing@lifespan.org
United States
 
NCT01428687
U01CA150387 - Study 2
No
Rena R. Wing, The Miriam Hospital
The Miriam Hospital
Not Provided
Principal Investigator: Rena R. Wing, PhD The Miriam Hospital
The Miriam Hospital
July 2014

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