N/A
Completed N=261
Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Source: ClinicalTrials.gov NCT02514889 ↗Enrolled (actual)
261
Serious AEs
0.4%
Results posted
Nov 2017
Primary outcomePrimary: Patient-centered Outcome Measure = Self-reported Hunger — 40.6; 40.8 units on a scale — p=0.30
Summary
Investigators from the University of California-Los Angeles (UCLA) and The Children's Clinic of Long Beach (TCC) are conducting a randomized, controlled comparative effectiveness trial of two government-sanctioned behavior change approaches to weight control with TCC's obese patients. The first approach is the calorie-counting calorie restriction (CC) approach used in the Diabetes Prevention Program. The second approach is the high-satiation/high-satiety approach represented by MyPlate.gov. The MyPlate nutritional goal is to double patient fruit and vegetable intake, legume intake, and whole grain intake. Both conditions stipulate 150 minutes of moderate physical activity a week. Study participants will be 300 of TCC's obese patients, 76% of whom are expected to be Latino, 13% African American and 11% Other Ethnicities.
The interventions will be implemented by trained community lifestyle change coaches with brief support from clinicians. The interventions will include two home visits, two group education sessions and seven telephone behavior change coaching sessions.
Compared to the CC approach, the MyPlate approach is hypothesized to yield better 12 months patient-centered outcomes, particularly self-reported satiety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-centered Outcome Measure = Self-reported Hunger |
40.6; 40.8 | 0.30 |
| PRIMARY Medical Outcome Measure = Body Weight |
80.5; 82.6 | 0.06 |
| PRIMARY Meal Satisfaction Yesterday |
83.4; 83.5 | 0.504 |
| PRIMARY Feeling Full After Last Meal Yesterday |
78.6; 78.6 | 0.30 |
| SECONDARY Systolic Blood Pressure |
121.6; 123.4 | 0.640 |
| SECONDARY Body Mass Index |
33.25; 34.01 | 0.747 |
| SECONDARY Waist Circumference |
98.6; 101.6 | 0.776 |
Eligibility Criteria
Inclusion Criteria
- Must be overweight (BMI > 25) or obese adult patient at The Childrens Clinic of Long Beach (TCC),
- interested in achieving desirable weight loss through behavior change.
- speak English or Spanish.
Exclusion Criteria
- Smoking in last 6 months,
- Currently pregnant,
- Medical condition preventing voluntary change in food choices or level of daily physical activity,
- Planning on moving out of the Long Beach area in the next two years.
- MyocardiaI Infarction, stroke or atherosclerotic cardiovascular disease procedure within the last 6 months
- Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g. End Stage Renal Disease on dialysis, cancer diagnosis or treatment within 2 yrs)
- Prior or planned bariatric surgery
- Use of prescription weight loss medication (including off label drugs e.g. topiramate, bupropion, byetta) or over-the-counter orlistat within 6 months
- Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine)
- Unintentional weight loss within past 6 months (≥ 5% of body weight)
- Intentional weight loss within past 6 months (≥ 5% of body weight)
- Pregnant or nursing within past 6 months
- Plans to become pregnant within 18 months
- Another member of household is a study participant or trial staff member
- Problem alcohol use: Self reported average consumption of > 14 alcoholic drink per week or 5+ drinks on any occasion in past week? for males and >7 drinks per week or 4+ drinks on any occasion in the past week for females
- Psychiatric hospitalization in last year
- Unstable angina
- Blood pressure >160/100 (note: individuals may be rescreened)
Data sourced from ClinicalTrials.gov (NCT02514889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.