Short Term Effects of Increasing Sleep Duration

Overweight and Obesity Clinical Trial

Official title:

Increasing Sleep Duration: A Novel Approach to Weight Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428687
• Other study ID #: U01CA150387 - Study 2
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2011
• Last updated: August 29, 2016
• Start date: August 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

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.
• No change in sleep
This group is taught to maintain their current sleep habits.

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	Eating Behavior	24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.	4 weeks	No
Secondary	Physical Activity	Objective measures of physical activity are obtained before and after the 4-week sleep intervention.	4 weeks	No