Portion Control Treatment for Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): portion control plate; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician; self-help booklets
Other intervention name(s): dietary counseling; weight loss intervention; self-help booklets(exercise and lifestyle changes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight; body mass index; obesity; portion control plate; diet; exercise