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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
Wm. Wrigley Jr. Company |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00971347 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Overweight Weight Loss |
Other: Extra sugar-free chewing gum sticks Behavioral: nutrition brochure |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Controlled Trial of Chewing Gum for Weight Loss |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: nutrition brochure
one-time at baseline visit
|
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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.
|
Other: Extra sugar-free chewing gum sticks
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.
Behavioral: nutrition brochure
one-time at baseline visit
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Darlene Higgins, BA | 205-934-6886 | dhiggins@uab.edu |
| Contact: James M. Shikany, DrPH | 205-934-4140 | jshikany@dopm.uab.edu |
| United States, Alabama | |
| University of Alabama at Birmingham Division of Preventive Medicine | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| Contact: James M. Shikany, DrPH 205-975-7989 jshikany@dopm.uab.edu | |
| Contact: Susan D. Chandler, MA 205-934-4140 annals@uab.edu | |
| Principal Investigator: David B. Allison, PhD | |
| Principal Investigator: James M. Shikany, DrPH | |
| Principal Investigator: | David B. Allison, PhD | University of Alabama at Birmingham |
| Principal Investigator: | James M. Shikany, DrPH | University of Alabama at Birmingham |
More Information
| Responsible Party: | The University of Alabama at Birmingham ( David B. Allison, PhD/Professor of Public Health ) |
| Study ID Numbers: | 000354619 |
| Study First Received: | September 2, 2009 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00971347 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
obesity overweight weight loss randomized controlled trial chewing gum |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |