CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 261 enrolled
Drug / intervention
Calorie-counting +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02514889
NCT02514889N/ACompleted

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

University of California, Los Angeles·interventional·Posted Aug 4, 2015·Updated Nov 20, 2017

In Brief

A clinical study evaluating Calorie-counting and MyPlate for Obesity. Completed, enrolled 261 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 4, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 23, 2017
Study CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.9 years ago

Interventions

Calorie-countingbehavioral

The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week. Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls.

MyPlatebehavioral

The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week. Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits \& vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls.