ObesityNCT00971347
Chewing Gum for Weight Loss
A study testing Extra sugar-free chewing gum sticks and nutrition brochure in people with Obesity and Overweight, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a randomized controlled trial of the effects of chewing gum on body weight. The investigators will randomly assign 200 overweight or mildly obese adults to one of two groups. Participants must be otherwise healthy and ages 19-50. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Extra sugar-free chewing gum sticks and nutrition brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2010
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19 - 50 years of age
- BMI 25 - 35 kg/m2
- Non-diabetic; no previous history of diabetes
- Fasting glucose <126 mg/dL at recruitment
- Male or female
- Any race or ethnicity
Who cannot join
- Any major disease including:
- Active cancer or cancer requiring treatment < 2 years (except nonmelanoma skin cancer).
- Active or chronic infections including self-reported HIV and active tuberculosis.
- Active cardiovascular disease or event with hospitalization; or therapeutic procedures for treatment of heart disease <6 months; or New York Heart Association Functional Class >2 for congestive heart failure, stroke or transient ischemic attack < 6 months.
- Uncontrolled hypertension: ≥SBP 160 mm Hg or DBP ≥95 mm Hg on treatment.
- GI disease: self-reported chronic hepatitis or cirrhosis; alcoholic hepatitis or alcoholic pancreatitis < 12 months; inflammatory bowel disease treatment < 12 months; recent or significant abdominal surgery.
Show all 26Show fewer
- Renal disease: serum creatinine ≥1.4 mg/dL (124 μmol/L) for men; ≥1.3 mg/dL (115 μmol/L) for women.
- Lung disease: chronic obstructive airway disease with use of oxygen.
- Diagnosed diabetes (type 1 or 2), fasting hyperglycemia (blood glucose ≥ 126 mg/dL), or use of any anti-diabetic medications.
- Uncompensated or uncontrolled psychiatric disease that would impede conduct of the trial or completion of procedures.
- Phenylketonuria.
- Temporomandibular joint disorders.
- < 16 natural, fully crowned, or restored teeth in a good state of repair.
- Inadequate oral hygiene.
- Sensitivity to flavors, sweeteners, or other ingredients in sugar-free chewing gum.
- Refusal to chew gum per study guidelines.
- Currently chewing ≥5 sticks of gum per week.
- Weight loss or gain of >10% in the past 6 months except post-partum weight loss.
- Current participation in any weight-reduction program.
- Current smoker or quit < 6 months.
- History of prior surgical procedure for weight control or liposuction.
- Unable or unwilling to give informed consent; unable to communicate with clinic staff; another household member is a participant or staff member in the trial; unwilling to accept randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away before trial completed; unable to walk 0.25 mile in 10 minutes.
- Currently pregnant or < 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the trial; unwilling to take adequate contraceptive measures if potentially fertile.
- Brief Symptom Inventory score (Derogatis \& Melisaratos, 1983) > 90th percentile.
- Any active use of illegal or illicit drugs or history of such use < 12 months. Excessive alcohol intake, acute or chronic: average consumption of 3+ alcohol containing beverages daily; consumption of 7+ alcoholic beverages within a 24-hr period <12 months; or other evidence available to clinic staff. Subject may still be considered eligible if, upon explanation, the clinic staff believe that the volunteer can and will limit future intake.
- This is a partial listing; complete list available from PIs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Division of Preventive Medicine
Birmingham, Alabama, 35205
About this study
Official title: Randomized Controlled Trial of Chewing Gum for Weight Loss
This is a randomized controlled trial of the effects of chewing gum on body weight. The investigators will randomly assign 200 overweight or mildly obese adults to one of two groups. Participants must be otherwise healthy and ages 19-50. The control group will receive only printed information on optimal diet and increasing physical activity. The intervention group will be instructed to chew gum following meals and in place of snacks for a minimum of 90 minutes per day. The intervention group also will receive the same information on optimal diet and increasing physical activity as the control group. In this 8-week intervention, the primary outcome will be change in body weight, and secondary outcomes will be changes in body mass income (BMI), waist circumference, and blood pressure. The protocol includes 3 clinic visits to assess outcomes: baseline, 4 weeks after randomization, and 8 weeks after randomization. Adherence to the gum chewing protocol will be assessed at clinic visits and during 2 telephone calls at 2 weeks and 6 weeks post-randomization. The investigators' hypothesis is that gum-chewers will lose more weight than those who receive information only.
Read the detailed description
In this randomized controlled trial of the effects of chewing gum on body weight, we will randomly assign 200 overweight or mildly obese, but otherwise healthy adults (men and women, ages 19 to 50), to one of two groups: 1) a control group, which will receive printed information on optimal diet and increasing physical activity only, or 2) an intervention group, in which participants will be instructed to chew gum following meals and in place of snacks for a minimum of 90 minutes per day, in addition to receiving the same information on optimal diet and increasing physical activity as the control group. In this 8-week intervention, the primary outcome will be change in body weight, and secondary outcomes will be changes in body mass income (BMI), waist circumference, and blood pressure. Outcome measures will be assessed in both groups via clinic visits at baseline, 4 weeks post-randomization, and 8 weeks post-randomization. Adherence to the gum chewing protocol will be assessed at the clinic visits, as well as during telephone contacts at 2 weeks and 6 weeks post-randomization. The effects of the chewing gum intervention will be assessed by analysis of covariance (ANCOVA), wherein treatment assignment is the independent variable; the outcome measures described above will serve as dependent variables; and pre-randomization factors such as age, sex, and baseline BMI will be used as covariates. Our hypothesis is that those randomized to the intervention group will lowe more weight than those randomized to the control group.
- Conditions
- Obesity, Overweight, Weight Loss
- Being tested
- Extra sugar-free chewing gum sticks, nutrition brochure
- Keywords
- obesity, overweight, weight loss, randomized controlled trial, chewing gum
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra sugar-free chewing gum sticksOther
Also called Extra sugar-free chewing gum
90 minutes chewing per day after meals; mid-morning and mid-afternoon; 1 to 2 hours after dinner; and in response to hunger, cravings, preoccupation with eating, or negative feelings in general throughout the day.
nutrition brochureBehavioural
Also called Finding Your Way to a Healthier You (GPO 001-000-04718-3)
one-time at baseline visit
| Study group | Role | What they receive |
|---|---|---|
| Nutrition brochure | Active comparator | Control participants will receive only a nutrition brochure, Finding Your Way to a Healthier You, based on a USDHHS/USDA publication, Dietary Guidelines for Americans 2005. Receives: Behavioral: nutrition brochure |
| Chewing gum + nutrition brochure | Experimental | Participants in the experimental arm will be instructed to incorporate gum chewing in their diet with a goal of at least 90 minutes per day. The schedule is 20 minutes each after breakfast, lunch and dinner plus 10 minutes mid-morning, mid-afternoon and 1 to 2 hours after dinner. Experimental participants also will be told to chew gum instead of unplanned eating in response to hunger, cravings, preoccupation with eating, or negative feelings. Receives: Other: Extra sugar-free chewing gum sticks; Behavioral: nutrition brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change in kg
Measured: 8 weeks
Secondary outcomes (3)
Body mass index in kilograms per meter-squared
Measured: 8 weeks
waist circumference in cm
Measured: 8 weeks
blood pressure in mm of mercury
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Wm. Wrigley Jr. Company
- Investigators
- David B. Allison, PhD, Principal investigator, University of Alabama at BirminghamJames M. Shikany, DrPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971347
- Sponsor's protocol ID
- 000354619
- Status last verified
- Nov 2010
- First submitted
- 2 Sep 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Chewing Gum for Weight Loss
- ClinicalTrials.gov ID
- NCT00971347
- Acronym / sponsor ID
- 000354619
- Conditions
- Obesity, Overweight, Weight Loss
- Keywords
- obesity, overweight, weight loss, randomized controlled trial, chewing gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Wm. Wrigley Jr. Company
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Sep 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 is a randomized controlled trial of the effects of chewing gum on body weight. The investigators will randomly assign 200 overweight or mildly obese adults to one of two groups. Participants must be otherwise healthy and ages 19-50. The control group will receive only printed information on optimal diet and increasing physical activity. The intervention group will be instructed to chew gum following meals and in place of snacks for a minimum of 90 minutes per day. The intervention group also will receive the same information on optimal diet and increasing physical activity as the control group. In this 8-week intervention, the primary outcome will be change in body weight, and secondary outcomes will be changes in body mass income (BMI), waist circumference, and blood pressure. The protocol includes 3 clinic visits to assess outcomes: baseline, 4 weeks after randomization, and 8 weeks after randomization. Adherence to the gum chewing protocol will be assessed at clinic visits and during 2 telephone calls at 2 weeks and 6 weeks post-randomization. The investigators' hypothesis is that gum-chewers will lose more weight than those who receive information only.
Detailed description
In this randomized controlled trial of the effects of chewing gum on body weight, we will randomly assign 200 overweight or mildly obese, but otherwise healthy adults (men and women, ages 19 to 50), to one of two groups: 1) a control group, which will receive printed information on optimal diet and increasing physical activity only, or 2) an intervention group, in which participants will be instructed to chew gum following meals and in place of snacks for a minimum of 90 minutes per day, in addition to receiving the same information on optimal diet and increasing physical activity as the control group. In this 8-week intervention, the primary outcome will be change in body weight, and secondary outcomes will be changes in body mass income (BMI), waist circumference, and blood pressure. Outcome measures will be assessed in both groups via clinic visits at baseline, 4 weeks post-randomization, and 8 weeks post-randomization. Adherence to the gum chewing protocol will be assessed at the clinic visits, as well as during telephone contacts at 2 weeks and 6 weeks post-randomization. The effects of the chewing gum intervention will be assessed by analysis of covariance (ANCOVA), wherein treatment assignment is the independent variable; the outcome measures described above will serve as dependent variables; and pre-randomization factors such as age, sex, and baseline BMI will be used as covariates. Our hypothesis is that those randomized to the intervention group will lowe more weight than those randomized to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition brochure | Active comparator | Behavioral: nutrition brochureControl participants will receive only a nutrition brochure, Finding Your Way to a Healthier You, based on a USDHHS/USDA publication, Dietary Guidelines for Americans 2005. |
| Chewing gum + nutrition brochure | Experimental | Other: Extra sugar-free chewing gum sticks, Behavioral: nutrition brochureParticipants in the experimental arm will be instructed to incorporate gum chewing in their diet with a goal of at least 90 minutes per day. The schedule is 20 minutes each after breakfast, lunch and dinner plus 10 minutes mid-morning, mid-afternoon and 1 to 2 hours after dinner. Experimental participants also will be told to chew gum instead of unplanned eating in response to hunger, cravings, preoccupation with eating, or negative feelings. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 19 - 50 years of age
- BMI 25 - 35 kg/m2
- Non-diabetic; no previous history of diabetes
- Fasting glucose <126 mg/dL at recruitment
- Male or female
Key exclusion criteria (26 listed)
- Any major disease including:
- Active cancer or cancer requiring treatment < 2 years (except nonmelanoma skin cancer).
- Active or chronic infections including self-reported HIV and active tuberculosis.
- Active cardiovascular disease or event with hospitalization; or therapeutic procedures for treatment of heart disease <6 months; or New York Heart Association Functional Class >2 for congestive heart failure, stroke or transient ischemic attack < 6 months.
- Uncontrolled hypertension: ≥SBP 160 mm Hg or DBP ≥95 mm Hg on treatment.
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 |
|---|---|---|
| Extra sugar-free chewing gum sticksAlso: Extra sugar-free chewing gum90 minutes chewing per day after meals; mid-morning and mid-afternoon; 1 to 2 hours after dinner; and in response to hunger, cravings, preoccupation with eating, or negative feelings in general throughout the day. | Other | Chewing gum + nutrition brochure |
| nutrition brochureAlso: Finding Your Way to a Healthier You (GPO 001-000-04718-3)one-time at baseline visit | Behavioural | Chewing gum + nutrition brochure, Nutrition brochure |
Primary outcome
weight change in kg
Time frame: 8 weeks
3 secondary outcomes
Body mass index in kilograms per meter-squared
Time frame: 8 weeks
waist circumference in cm
Time frame: 8 weeks
blood pressure in mm of mercury
Time frame: 8 weeks
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 23 Nov 2010.
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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.
David B. Allison, PhD principal investigator
University of Alabama at Birmingham
James M. Shikany, DrPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra sugar-free chewing gum sticks and nutrition brochure in people with Obesity and Overweight, run by University of Alabama at Birmingham 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 6 inclusion and 26 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 23 Nov 2010. 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 change in kg (time frame: 8 weeks). 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 23 Nov 2010.