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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portion Control Intervention | Active Comparator | Individuals will be given a portion control plate and dietary counseling |
|
| Usual Care | Placebo Comparator | Provided with self-help booklets on diet and exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| portion control plate | Behavioral | Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 6 Months | Weight change as a percentage of baseline at post 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change at 3 Months | Percentage change in weight at 3 months post study baseline | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon O Ebbert, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21906302 | Result | Kesman RL, Ebbert JO, Harris KI, Schroeder DR. Portion control for the treatment of obesity in the primary care setting. BMC Res Notes. 2011 Sep 9;4:346. doi: 10.1186/1756-0500-4-346. |
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Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Portion Control Intervention | Individuals will be given a portion control plate and dietary counseling |
| FG001 | Usual Care | Provided with self-help booklets on diet and exercise. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Portion Control Intervention | Individuals will be given a portion control plate and dietary counseling |
| BG001 | Usual Care | Provided with self-help booklets on diet and exercise. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Weight Change at 3 Months | Percentage change in weight at 3 months post study baseline | Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward. | Posted | Mean | Standard Deviation | percentage | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Portion Control Intervention | Individuals will be given a portion control plate and dietary counseling |
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small sample size and inability to blind staff/study subject to the intervenion
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon O. Ebbert, MD | Mayo Clinic | 507-255-3965 | ebbert.jon@mayo.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Usual Care | Behavioral | self-help booklets |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Weight | Weight in Kilograms at the study entry | Mean | Standard Deviation | Kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Weight Change at 6 Months | Weight change as a percentage of baseline at post 6 months. | Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward. | Posted | Mean | Standard Deviation | percentage | 6 months |
|
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Usual Care | Provided with self-help booklets on diet and exercise. | 0 | 32 | 0 | 32 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |