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Portion Control Treatment for Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Ebbert, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01451554
First received: October 11, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Obesity
Behavioral: portion control plate
Behavioral: Usual Care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Portion Control for the Treatment of Obesity in the Primary Care Setting

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Weight Change at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight change as a percentage of baseline at post 6 months.


Secondary Outcome Measures:
  • Weight Change at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percentage change in weight at 3 months post study baseline


Enrollment: 65
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • portion control plate
  • 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451554

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jon O Ebbert, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Jon Ebbert, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01451554     History of Changes
Other Study ID Numbers: 02-003653
Study First Received: October 11, 2011
Results First Received: October 19, 2011
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
weight
body mass index
obesity
portion control plate
diet
exercise

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014