Back to resultsSleep Plus Eating Routines for Weight Loss
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Education
Sleep and Eating Routine
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Weight loss
Eligibility Criteria
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
Sites / Locations
- Weight Control & Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Weight Loss Education
Sleep and Eating Routine
Arm Description
Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01717352
Brief Title
Sleep Plus Eating Routines for Weight Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 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
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.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight Loss Education
Arm Type
Active Comparator
Arm Description
Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
Arm Title
Sleep and Eating Routine
Arm Type
Active Comparator
Arm Description
Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Education
Intervention Type
Behavioral
Intervention Name(s)
Sleep and Eating Routine
Primary Outcome Measure Information:
Title
Weight
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Executive Control
Description
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.
Time Frame
4 and 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
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Sleep Plus Eating Routines for Weight Loss
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