Obesity
Conditions
Keywords
weight, body mass index, obesity, portion control plate, diet, exercise
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.
Interventions
BEHAVIORALportion control plate
Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
BEHAVIORALUsual Care
self-help booklets
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change at 6 Months | 6 months | Weight change as a percentage of baseline at post 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change at 3 Months | 3 months | Percentage change in weight at 3 months post study baseline |
Countries
United States
Participant flow
Recruitment details
Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.
Participants by arm
| Arm | Count |
|---|---|
| Portion Control Intervention Individuals will be given a portion control plate and dietary counseling | 33 |
| Usual Care Provided with self-help booklets on diet and exercise. | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 14 | 9 |
Baseline characteristics
| Characteristic | Usual Care | Portion Control Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 5 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 28 Participants | 52 Participants |
| Age Continuous | 56.3 years STANDARD_DEVIATION 10.7 | 55.4 years STANDARD_DEVIATION 9.4 | 55.9 years STANDARD_DEVIATION 10 |
| Baseline Weight | 98.8 Kg STANDARD_DEVIATION 12.5 | 97.6 Kg STANDARD_DEVIATION 12.8 | 98.2 Kg STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
Weight Change at 6 Months
Weight change as a percentage of baseline at post 6 months.
Time frame: 6 months
Population: Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portion Control Intervention | Weight Change at 6 Months | -1.2 percentage | Standard Deviation 3.1 |
| Usual Care | Weight Change at 6 Months | -0.4 percentage | Standard Deviation 3.2 |
Comparison: Data were compared between groups using a 2 sample T-test.p-value: 0.31t-test, 2 sided
Secondary
Weight Change at 3 Months
Percentage change in weight at 3 months post study baseline
Time frame: 3 months
Population: Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portion Control Intervention | Weight Change at 3 Months | -1.7 percentage | Standard Deviation 3.3 |
| Usual Care | Weight Change at 3 Months | -0.4 percentage | Standard Deviation 1.9 |
Comparison: Data were compared between groups using the 2 sample T-test.p-value: 0.06t-test, 2 sided