Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00871676
• Collaborator: St. Luke's-Roosevelt Hospital Center (Other)
• Enrollment: 146
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Behavioral: Lifestyle modification; Behavioral: Lifestyle modification plus gum	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• 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
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Weight loss [Week 16 and 52]

Secondary Outcome Measures

1. Appetite control [Weeks 4, 8, 12, 16 and 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00871676
• Other Study ID Numbers: 804361
• First Posted: Mar 30, 2009
• Last Update Posted: Aug 17, 2016
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Overweight; Weight Loss

Study Results

No Results Posted as of Aug 17, 2016