OverweightNCT00871676
Use of Chewing Gum to Facilitate Appetite Control and Weight Loss
A study testing Lifestyle modification and Lifestyle modification plus gum in people with Overweight and Obesity, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Lifestyle modification and Lifestyle modification plus gum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-75 years of age
- Body Mass Index of 25-45 inclusive
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification
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.
- Conditions
- Overweight, Obesity
- Being tested
- Lifestyle modification, Lifestyle modification plus gum
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Also called Behavior modification, Behavioral weight loss
16 weekly followed by 8 monthly group behavioral weight loss sessions.
Lifestyle modification plus gumBehavioural
Also called Behavior modification, Behavioral weight loss
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Overweight/obese individuals being treated with lifestyle modification to facilitate weight loss. Receives: Behavioral: Lifestyle modification |
| 2 | Experimental | Lifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons. Receives: Behavioral: Lifestyle modification plus gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: Week 16 and 52
Secondary outcomes (1)
Appetite control
Measured: Weeks 4, 8, 12, 16 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Investigators
- Thomas A Wadden, Ph.D, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871676
- Sponsor's protocol ID
- 804361
- Status last verified
- Mar 2009
- First submitted
- 27 Mar 2009
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification
- ClinicalTrials.gov ID
- NCT00871676
- Acronym / sponsor ID
- 804361
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Study start
- May 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Lifestyle modificationOverweight/obese individuals being treated with lifestyle modification to facilitate weight loss. |
| 2 | Experimental | Behavioral: Lifestyle modification plus gumLifestyle modification plus use of chewing gum to facilitate weight loss in overweight/obese persons. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 21-75 years of age
- Body Mass Index of 25-45 inclusive
Key exclusion criteria (16 listed)
- major medical psychiatric conditions
- medications know to effect weight
- full or partial dentures
- 18 or fewer teeth
- regular gum chewing (≥ 2 pieces/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modificationAlso: Behavior modification, Behavioral weight loss16 weekly followed by 8 monthly group behavioral weight loss sessions. | Behavioural | 1 |
| Lifestyle modification plus gumAlso: Behavior modification, Behavioral weight loss16 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. | Behavioural | 2 |
Primary outcome
Weight loss
Time frame: Week 16 and 52
1 secondary outcome
Appetite control
Time frame: Weeks 4, 8, 12, 16 and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Wadden, Ph.D principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification and Lifestyle modification plus gum in people with Overweight and Obesity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Week 16 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.