Sleep Plus Eating Routines for Weight Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 7, 2014
Last verified: July 2014
  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:


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: August 2015
Estimated Primary Completion Date: August 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Weight loss

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 16, 2014