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Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871676
First Posted: March 30, 2009
Last Update Posted: August 17, 2016
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.
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by:
University of Pennsylvania
  Purpose
This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle modification to facilitate appetite control and weight loss in overweight and obese individuals.

Condition Intervention
Overweight Obesity Behavioral: Lifestyle modification Behavioral: Lifestyle modification plus gum

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Week 16 and 52 ]

Secondary Outcome Measures:
  • Appetite control [ Time Frame: Weeks 4, 8, 12, 16 and 52 ]

Enrollment: 146
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.
Behavioral: Lifestyle modification
16 weekly followed by 8 monthly group behavioral weight loss sessions.
Other Names:
  • Behavior modification
  • Behavioral weight loss
Experimental: 2
Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.
Behavioral: Lifestyle modification plus gum
16 weekly followed by 8 monthly group behavioral weight loss sessions. Subjects were also given gum along with instructions for times and occasions to chew with the aim of facilitating weight loss and appetite control.
Other Names:
  • Behavior modification
  • Behavioral weight loss

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-75 years of age
  • Body Mass Index of 25-45 inclusive

Exclusion Criteria:

  • major medical psychiatric conditions
  • medications know to effect weight
  • full or partial dentures
  • 18 or fewer teeth
  • regular gum chewing (≥ 2 pieces/day)
  • use of any tobacco product
  • sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins)
  • history of PKU
  • sensitivity or allergy to aspartame
  • current/history of alcohol abuse or addiction (within 5 year)
  • recreational drug use
  • recent significant weight change (+/- 5% in previous 6 months)
  • currently pregnant or nursing and willingness not to get pregnant during course of study
  • participation in any other research studies
  • proximity to clinic (within one hour)
  • access to reliable transportation
  Contacts and Locations
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): NCT00871676


Locations
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Thomas A Wadden, Ph.D University of Pennsylvania
  More Information

Responsible Party: Kathleen McMahon, Ph.D, RD, William Wrigley Jr. Company
ClinicalTrials.gov Identifier: NCT00871676     History of Changes
Other Study ID Numbers: 804361
First Submitted: March 27, 2009
First Posted: March 30, 2009
Last Update Posted: August 17, 2016
Last Verified: March 2009

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