WITHDRAWN: Myplate High-Satiety Approach Versus Calorie Counting Comparative Effectiveness Randomized Controlled Trial for Treatment of Overweight in Predominantly Latino Low-Income Patients

Introduction: Federally-recommended approach to treating overweight patients is calorie counting (CC) but alternative MyPlate.gov high-satiety approach (MyP) was introduced in 2011. MyPlate recommends eating more fruits and vegetables, making half of grain choices whole grain, replacing sugary drinks with water, limiting sodium intake. MyP may satisfy more than CC long-term. Objectives: Conduct 1-year comparative effectiveness trial of CC and MyP approaches. Hypothesis #1: MyPlate approach yields greater satiety, increased mental health, higher patient quality of life and reduced blood pressure than CC approach at 12 months follow-up. Hypothesis #2: Both approaches will reduce body weight and waist circumference equally.

Methods: Design: 261 study participants randomly assigned to either the CC (n=130) or MyP (n=131) conditions. Setting: A federally qualified health center in Long Beach, California. Patients: Mostly Latino and African American low-income overweight primary care patients. Characteristics: 95% female, 86% Latino, 8% African American. Mean age: 41 years. Interventions: Following primary care provider approval and encouragement, all patients were invited to participate in two 1-hour home-based health education sessions, two 1-hour group education sessions, and seven 15-20 minute telephone coaching sessions over 6 months. MyP participants also attended two 1-hour cooking demonstrations. Trained bilingual community health workers conducted lifestyle change coaching in either English or Spanish. Main and secondary outcome measures: Assessments included questionnaire measures, anthropometry, and food frequency questionnaires assessed at baseline, 6- and 12-months follow-up. Main outcome: Perceived satiety (fullness, meal satisfaction, hunger-reverse-scored). Secondary outcomes: Waist circumference, mental health, quality of life.

Results: Study retention: 80.1% at 12 months follow-up. Hypothesis #1: satiety, mental health and quality of life improved in both conditions. Hypothesis #2: waist circumference declined in both conditions, as predicted, but body weight was unchanged.

Conclusions: Both intervention approaches increased satiety, mental health, quality of life and reduced waist circumference at 12 months follow-up.