Use of Chewing Gum to Facilitate Appetite Control and Wei... | NCT00871676

Studies
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss

NCT00871676

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Aug 17, 2016Estimated

Enrollment

146Actual

Phase

Not Applicable

Conditions

Overweight
Obesity

Interventions

Lifestyle modification
Lifestyle modification plus gum

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Mar 27, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2016

Last Update Posted Date

Aug 17, 2016Estimated

Name	Class
St. Luke's-Roosevelt Hospital Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss.	Behavioral: Lifestyle modification
2	Experimental	Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons.	Behavioral: Lifestyle modification plus gum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lifestyle modification	Behavioral	16 weekly followed by 8 monthly group behavioral weight loss sessions.	1

Measure	Description	Time Frame
Weight loss		Week 16 and 52

Measure	Description	Time Frame
Appetite control		Weeks 4, 8, 12, 16 and 52

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas A Wadden, Ph.D	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania School of Medicine		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001521	Behavior Therapy
D002638	Chewing Gum

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D053149	Plant Gums
D001704	Biopolymers

Browse Leaves

Not provided

Browse Branches

Not provided