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Portion Control Treatment for Obesity

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ClinicalTrials.gov Identifier: NCT01451554
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : November 28, 2011
Last Update Posted : November 28, 2011
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic

Brief Summary:
To date, no studies have been published assessing the effectiveness of portion control interventions in a primary care setting. The investigators will conduct a pilot study to assess the effectiveness of an intervention including a portion control plate and dietary counseling for weight loss among obese patients in a general medicine primary care practice.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: portion control plate Behavioral: Usual Care Phase 2 Phase 3

Detailed Description:

2-3 weeks prior to the patient's appointment with their primary care physician, the patient's medical record is reviewed to assess eligibility. If eligible, baseline patient characteristics are recorded, and a letter is sent to the patient informing them of the study and asking them to discuss this further with their primary care provider at their upcoming appointment.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Portion Control for the Treatment of Obesity in the Primary Care Setting
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Portion Control Intervention
Individuals will be given a portion control plate and dietary counseling
Behavioral: portion control plate
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
Other Names:
  • dietary counseling
  • weight loss intervention

Placebo Comparator: Usual Care
Provided with self-help booklets on diet and exercise.
Behavioral: Usual Care
self-help booklets
Other Name: self-help booklets(exercise and lifestyle changes)

Primary Outcome Measures :
  1. Weight Change at 6 Months [ Time Frame: 6 months ]
    Weight change as a percentage of baseline at post 6 months.

Secondary Outcome Measures :
  1. Weight Change at 3 Months [ Time Frame: 3 months ]
    Percentage change in weight at 3 months post study baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Body Mass Index greater than 29 or less than 40
  • Age between 18 and 75

Exclusion Criteria:

  • Presence of active cancer
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451554

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Jon O Ebbert, MD Mayo Clinic
Publications of Results:
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Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01451554    
Other Study ID Numbers: 02-003653
First Posted: October 13, 2011    Key Record Dates
Results First Posted: November 28, 2011
Last Update Posted: November 28, 2011
Last Verified: October 2011
Keywords provided by Jon Ebbert, Mayo Clinic:
body mass index
portion control plate
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight