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Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00871676
First received: March 27, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Weight loss [ Time Frame: Week 16 and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appetite control [ Time Frame: Weeks 4, 8, 12, 16 and 52 ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: May 2006
Estimated Study Completion Date: December 2008
Primary Completion Date: July 2008 (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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kathleen McMahon, Ph.D, RD, William Wrigley Jr. Company
ClinicalTrials.gov Identifier: NCT00871676     History of Changes
Other Study ID Numbers: 804361
Study First Received: March 27, 2009
Last Updated: March 27, 2009
Health Authority: United States: Institutional Review Board

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 21, 2013