NCT02514889

Is MyPlate Approach to Helping Overweight Patients Lose Weight More Patient-centered?

Completed NA Results posted Last updated 20 November 2017

What this trial tests

NA trial testing Calorie-counting in Obesity in 261 participants. Completed in 31 July 2017.

Timeline

1 July 2015

Primary endpoint
23 March 2017

31 July 2017

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	261
Start date	1 July 2015
Primary completion	23 March 2017
Estimated completion	31 July 2017
Sites	2 locations across United States

Drugs / interventions tested

• Calorie-counting
• MyPlate

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient-centered Outcome Measure = Self-reported Hunger Primary · 12 months follow-up

Response to question: "Thinking about yesterday, how hungry did you feel during the day?" Response was a mark on a 100mm scale or oral response on a scale from 0 to 100 (for participants assessed via phone), 0="Not at all hungry" and 100="Extremely hungry."

Group	Value	95% CI
MyPlate	40.6	± 2.33
Calorie-counting	40.8	± 2.14

Medical Outcome Measure = Body Weight Primary · 12 months follow-up

Body weight, measured in kilograms, was obtained by having shoeless participants dressed in light clothing stand on a regularly calibrated medical scale. Measures were taken twice. If these measures differed by more than 0.2 kg, a third measure was taken and averaged with the other two.

Group	Value	95% CI
MyPlate	80.5	± 1.19
Calorie-counting	82.6	± 1.48

Meal Satisfaction Yesterday Primary · 12 months follow-up

"Take a moment to think about the last meal you ate yesterday. Thinking about the last meal you ate, how satisfied were you after the meal?" Response was a mark on a 100 mm visual analogue scale or response to oral question on a scale from 0 to 100 (for participants assessed via phone), with the low end (0) anchored by "Very satisfied" and the high end (100) anchored by "Very unsatisfied." For analysis purposes this measure was reverse-scored, so that higher values represented greater meal satisfaction.

Group	Value	95% CI
MyPlate	83.4	± 2.51
Calorie-counting	83.5	± 2.48

Feeling Full After Last Meal Yesterday Primary · 12 months follow-up

"Take a moment to think about the last meal yesterday. Thinking about the last meal you ate, how full did you feel after that meal?" Response was a mark on a 100 mm visual analogue scale (VAS), or oral response to question on a scale from 0 to 100 (for participants assessed via phone), 0="Extremely full" and 100="Not at all full." For analysis purposes this measure was reverse-scored, so that higher values represented greater fullness.

Group	Value	95% CI
MyPlate	78.6	± 2.10
Calorie-counting	78.6	± 2.51

Systolic Blood Pressure Secondary · 12 months follow-up

Systolic blood pressure assessed on participant's left arm while participant is seated, after at least 5 minutes of rest. Automated, regularly calibrated sphygmomanometer was used with oversize cuffs for obese arms.

Group	Value	95% CI
MyPlate	121.6	± 1.43
Calorie-counting	123.4	± 2.05

Body Mass Index Secondary · 12 months follow-up

Body mass index is weight in kilograms divided by the square of the participant's height measured in meters. Wall-mounted stadiometer was used to assess height. Weekly-calibrated, portable, digital scales were used to assess body weight.

Group	Value	95% CI
MyPlate	33.25	± 0.3457
Calorie-counting	34.01	± 0.3496

Waist Circumference Secondary · 12 months follow-up

The waist circumference was assessed using research standard waist circumference measuring tapes. The result was measured to closest 0.1 cm. The assessor was instructed to position the measuring tape horizontally around the waist, just above the iliac crest.

Group	Value	95% CI
MyPlate	98.6	± 0.91
Calorie-counting	101.6	± 1.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were heavily monitored during the intervention phase, usually months 1-3 of their participation and then lightly for assessment-only purposes for months 4-12.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Calorie-counting

Serious: 0/130 (0%)

Deaths: 0/130

MyPlate

Serious: 1/131 (1%)

Deaths: 1/131

Serious adverse events (1 terms)

Reaction	System	Calorie-counting	MyPlate
Death	General disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Calorie-counting	MyPlate
Medical issues (unspecified)	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT02514889 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dietary Approaches to Stop Hypertension (DASH) for the primary and secondary prevention of cardiovascular diseases.
   Bensaaud A, Seery S, Gibson I, Jones J, et al · · 2025 · cited 7× · PMID 40326569 · DOI 10.1002/14651858.cd013729.pub2
2. Comparative effectiveness trial comparing MyPlate to calorie counting for mostly low-income Latino primary care patients of a federally qualified community health center: study design, baseline characteristics.
   Gelberg L, Rico MW, Herman DR, Belin TR, et al · · 2019 · cited 6× · PMID 31340800 · DOI 10.1186/s12889-019-7294-z
3. Randomized Comparative Effectiveness Trial of 2 Federally Recommended Strategies to Reduce Excess Body Fat in Overweight, Low-Income Patients: MyPlate.gov vs Calorie Counting.
   McCarthy WJ, Rico M, Chandler M, Herman DR, et al · · 2023 · cited 5× · PMID 37217336 · DOI 10.1370/afm.2964