Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

NCT ID: NCT00871676

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.

Group Type ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type BEHAVIORAL

16 weekly followed by 8 monthly group behavioral weight loss sessions.

2

Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.

Group Type EXPERIMENTAL

Lifestyle modification plus gum

Intervention Type BEHAVIORAL

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.

Interventions

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Lifestyle modification

16 weekly followed by 8 monthly group behavioral weight loss sessions.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavior modification Behavioral weight loss Behavior modification Behavioral weight loss

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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William Wrigley Jr. Company

Principal Investigators

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Thomas A Wadden, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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804361

Identifier Type: -

Identifier Source: org_study_id

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