Text Size

Sleep Plus Eating Routines for Weight Loss

This study is currently recruiting participants.
Verified November 2012 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
Rena R. Wing, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01717352
First received: October 26, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Overweight and Obesity
 Behavioral: Weight Loss Education
Behavioral: Sleep and Eating Routine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Weight [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Executive Control [ Time Frame: 4 and 20 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717352

Locations
United States, Rhode Island
Weight Control & Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Rena R Wing, PhD     401-793-8959     rwing@lifespan.org    
Principal Investigator: Rena R Wing, PhD            
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Rena R Wing, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: Rena R. Wing, Professor of Psychiatry & Human Behavior, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01717352     History of Changes
Other Study ID Numbers: U01CA150387-Study 5
Study First Received: October 26, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Weight loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013