Randomized Controlled Trial of Chewing Gum for Weight Loss
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- weight change in kg
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
weight change in kg
Time Frame: 8 weeks
Secondary Outcomes
- blood pressure in mm of mercury(8 weeks)
- Body mass index in kilograms per meter-squared(8 weeks)
- waist circumference in cm(8 weeks)