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OpenTrials
Completed

NCT Number: NCT01451554

Portion Control Treatment for Obesity

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

portion control plate

Behavioral

Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician

Other names: dietary counseling, weight loss intervention

Usual Care

Behavioral

self-help booklets

Other names: self-help booklets(exercise and lifestyle changes)

Primary outcomes

  1. Weight Change at 6 Months

    Time frame: 6 months

    Weight change as a percentage of baseline at post 6 months.

Secondary outcomes

  1. Weight Change at 3 Months

    Time frame: 3 months

    Percentage change in weight at 3 months post study baseline

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 13, 2011
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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