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NCT01717352 Clinical Trial

Sleep Plus Eating Routines for Weight Loss

Overweight and Obesity Clinical Trial

Official title:
Increasing Sleep Duration: A Novel Approach to Weight Control. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01717352
Other study ID # U01CA150387-Study 5
Secondary ID U01CA150387
Status Completed
Phase Phase 2
First received October 26, 2012
Last updated January 3, 2017
Start date September 2012
Est. completion date March 2016

Study information
Verified date January 2017
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- age 21 to 65

- BMI 25 to 45

- sleep 7 hours or less most nights

Exclusion Criteria:

- use of medications affecting sleep

- sleep apnea

- shift work

Study Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Weight Loss Education

• Sleep and Eating Routine

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 Weight 20 weeks No
Secondary Executive Control Executive control is measured by a variety of computer assessments. These include Go-No Go, delayed discounting, and perseverence as measured by mirror tracing and a hand grip task. 4 and 20 weeks No
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