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Chewing Gum for Weight Loss

NCT00971347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-11-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Wm. Wrigley Jr. Company

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David B. Allison, PhD · University of Alabama at Birmingham

  • James M. Shikany, DrPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971347 on ClinicalTrials.gov