Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
65 participants
INTERVENTIONAL
2009-01-31
2010-12-31
Brief Summary
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Detailed Description
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At the primary care appointment, the patient is informed of the study and asked if they would like to participate. If the patient declines, their response is recorded. If the patient accepts, authorization is obtained and the patient is randomized by drawing a sealed envelope from either the male box or the female box, with both boxes being randomized. The envelope indicates either portion control plate or usual care. If the patient is randomized to usual care, Mayo Clinic pamphlets entitled "Lifestyle Changes for Healthy Weight" and "Exercise: Getting Started and Staying With It" are given to the patient. If the patient is randomized to the portion control plate, a 60 minute appointment with a dietician is scheduled. For pre-menopausal female patients who have not had a hysterectomy, a urine pregnancy test is performed to confirm that the patient is not pregnant prior to participation in the study.
At the dietitian appointment, the patient is given general information regarding portion size control and specific instructions on how to use a commercially calibrated portion control plate/bowl. The patient receives a handout containing instructions on how to use the plate/bowl along with food suggestions. The patient is instructed to use the plate for their largest meal of the day and encouraged to use the plate/bowl for all meals. The patient is also given a simple log-sheet to document the meals each day for which they used the plate/bowl.
The patients are then followed for 6 months. All patients are scheduled for weigh-ins at 3 months and 6 months. Patients in the portion control plate group are also contacted by phone or email (according to patient preference) at 1, 3, and 5 months by the dietitian to check-in and answer all questions. At completion of the study, patients in the portion control group are provided with a survey to assess their satisfaction with the intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Portion Control Intervention
Individuals will be given a portion control plate and dietary counseling
portion control plate
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
Usual Care
Provided with self-help booklets on diet and exercise.
Usual Care
self-help booklets
Interventions
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portion control plate
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
Usual Care
self-help booklets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 75
Exclusion Criteria
* Current participation in an organized weight loss program
* Current use of a weight loss medication
* History of bulimia or anorexia
* Current treatment for psychiatric illness other than anxiety or depression
* Surgery within the 3 months before enrollment or planned during the study period
* Past gastric bypass surgery or planned gastric bypass surgery during the - study period
* Current pregnancy or planned pregnancy during the study period
18 Years
75 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Jon Ebbert
Principal Investigator
Principal Investigators
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Jon O Ebbert, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Kesman RL, Ebbert JO, Harris KI, Schroeder DR. Portion control for the treatment of obesity in the primary care setting. BMC Res Notes. 2011 Sep 9;4:346. doi: 10.1186/1756-0500-4-346.
Other Identifiers
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02-003653
Identifier Type: -
Identifier Source: org_study_id