Back to resultsShort Term Effects of Increasing Sleep Duration
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sleep Duration
No change in sleep
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Weight loss, Sleep duration
Eligibility 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
Sites / Locations
- Weight Control & Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Increase Sleep Gradually
Increase Sleep Immediately
No Intervention: Control Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Sleep Duration
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
24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.
Physical Activity
Objective measures of physical activity are obtained before and after the 4-week sleep intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01428687
Brief Title
Short Term Effects of Increasing Sleep Duration
Official Title
Increasing Sleep Duration: A Novel Approach to Weight Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Weight loss, Sleep duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Increase Sleep Gradually
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Increase Sleep Immediately
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Intervention: Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Sleep Duration
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No change in sleep
Intervention Description
This group is taught to maintain their current sleep habits.
Primary Outcome Measure Information:
Title
Sleep Duration
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Eating Behavior
Description
24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.
Time Frame
4 weeks
Title
Physical Activity
Description
Objective measures of physical activity are obtained before and after the 4-week sleep intervention.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena R. Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Short Term Effects of Increasing Sleep Duration
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