Chewing Gum for Weight Loss
Condition: Obesity; Overweight; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Extra sugar-free chewing gum sticks; nutrition brochure
Intervention type(s): Other; Behavioral
Intervention description(s): 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.; one-time at baseline visit
Other intervention name(s): Extra sugar-free chewing gum; Finding Your Way to a Healthier You (GPO 001-000-04718-3)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; overweight; weight loss; randomized controlled trial; chewing gum