Portion Control Treatment for Obesity

October 19, 2011 updated by: Jon Ebbert, Mayo Clinic

Portion Control for the Treatment of Obesity in the Primary Care Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • self-help booklets(exercise and lifestyle changes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change at 6 Months
Time Frame: 6 months
Weight change as a percentage of baseline at post 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change at 3 Months
Time Frame: 3 months
Percentage change in weight at 3 months post study baseline
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2011

Last Update Submitted That Met QC Criteria

October 19, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-003653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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