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Sleep Plus Eating Routines for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01717352
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Weight Loss Education Behavioral: Sleep and Eating Routine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Weight Loss Education
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.
 Behavioral: Weight Loss Education
Active Comparator: Sleep and Eating Routine
Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes.
 Behavioral: Sleep and Eating Routine


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Executive Control [ Time Frame: 4 and 20 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717352


Locations
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United States, Rhode Island
Weight Control & Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Rena R Wing, PhD The Miriam Hospital
More Information
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Responsible Party: Rena R. Wing, Professor of Psychiatry & Human Behavior, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01717352    
Other Study ID Numbers: U01CA150387-Study 5
U01CA150387 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Keywords provided by Rena R. Wing, The Miriam Hospital:
Weight loss
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Body Weight Changes