Portion Control Treatment for Obesity

Phase 2

Completed

• Conditions: Obesity
• Interventions: Behavioral: Usual Care; Behavioral: portion control plate

• Registration Number: NCT01451554
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2011-10
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-13
• Results First Submitted: 2011-10-19
• Results First Submitted QC: 2011-10-19
• Last Update Submitted: 2011-10-19
• Results First Posted: 2011-11-28
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Provided with self-help booklets on diet and exercise.
Portion Control Intervention	portion control plate	Individuals will be given a portion control plate and dietary counseling

Primary Outcome Measures

Name	Time	Method
Weight Change at 6 Months	6 months	Weight change as a percentage of baseline at post 6 months.

Secondary Outcome Measures

Name	Time	Method
Weight Change at 3 Months	3 months	Percentage change in weight at 3 months post study baseline

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States