Use of Chewing Gum to Facilitate Appetite Control and Weight Loss
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 17, 2016
March 1, 2009
3.6 years
March 27, 2009
August 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Weight loss
Week 16 and 52
Secondary Outcomes (1)
Appetite control
Weeks 4, 8, 12, 16 and 52
Study Arms (2)
1
ACTIVE COMPARATOROverweight/obese individuals being treated with lifestyle modification to facilitate weight loss.
2
EXPERIMENTALLifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.
Interventions
16 weekly followed by 8 monthly group behavioral weight loss sessions.
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.
Eligibility Criteria
You may qualify if:
- years of age
- Body Mass Index of 25-45 inclusive
You may not qualify if:
- major medical psychiatric conditions
- medications know to effect weight
- full or partial dentures
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- St. Luke's-Roosevelt Hospital Centercollaborator
Study Sites (1)
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A Wadden, Ph.D
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
May 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
August 17, 2016
Record last verified: 2009-03