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.

BACKGROUND: Primary care-based behavior change obesity treatment has long featured the Calorie restriction (CC), portion control approach. By contrast, the MyPlate-based obesity treatment approach encourages eating more high-satiety/high-satiation foods and requires no calorie-counting. This report describes study methods of a comparative effectiveness trial of CC versus MyPlate. It also describes baseline findings involving demographic characteristics and their associations with primary outcome measures and covariates, including satiety/satiation, dietary quality and acculturation. METHODS: A comparative effectiveness trial was designed to compare the CC approach (n = 130) versus a MyPlate-based approach (n = 131) to treating patient overweight. Intervenors were trained community health workers. The 11 intervention sessions included two in-home health education sessions, two group education sessions, and seven telephone coaching sessions. Questionnaire and anthropometric assessments occurred at baseline, 6- and 12 months; food frequency questionnaires were administered at baseline and 12 months. Participants were overweight adult primary care patients of a federally qualified health center in Long Beach, California. Two measures of satiety/satiation and one measure of post-meal hunger comprised the primary outcome measures. Secondary outcomes included weight, waist circumference, blood pressure, dietary quality, sugary beverage intake, water intake, fruit and vegetable fiber intake, mental health and health-related quality of life. Covariates included age, gender, nativity status (U.S.-born, not U.S.-born), race/ethnicity, education, and acculturation. ANALYSIS: Baseline characteristics were compared using chi square tests. Associations between covariates and outcome measures were evaluated using multiple regression and logistic regression. RESULTS: Two thousand eighty-six adult patients were screened, yielding 261 enrollees who were 86% Latino, 8% African American, 4% White and 2% Other. Women predominated (95%). Mean age was 42 years. Most (82%) were foreign-born; 74% chose the Spanish language option. Mean BMI was 33.3 kg/m2; mean weight was 82 kg; mean waist circumference was 102 cm. Mean blood pressure was 122/77 mm. Study arms on key baseline measures did not differ except on dietary quality and sugary beverage intake. Nativity status was significantly associated with dietary quality. CONCLUSIONS: The two treatment arms were well-balanced demographically at baseline. Nativity status is inversely related to dietary quality. TRIAL REGISTRATION: NCT02514889 , posted on 8/4/2015.

A pilot replication of QUIT, a randomized controlled trial of a brief intervention for reducing risky drug use, among Latino primary care patients.

BACKGROUND: QUIT is the only primary care-based brief intervention that has previously shown efficacy for reducing risky drug use in the United States (Gelberg et al., 2015). This pilot study replicated the QUIT protocol in one of the five original QUIT clinics primarily serving Latinos. DESIGN: Single-blind, two-arm, randomized controlled trial of patients enrolled from March-October 2013 with 3-month follow-up. SETTING: Primary care waiting room of a federally qualified health center (FQHC) in East Los Angeles. PARTICIPANTS: Adult patients with risky drug use (4-26 on the computerized WHO ASSIST): 65 patients (32 intervention, 33 control); 51 (78%) completed follow-up; mean age 30.8 years; 59% male; 94% Latino. INTERVENTIONS AND MEASURES: Intervention patients received: 1) brief (typically 3-4 minutes) clinician advice to quit/reduce their risky drug use, 2) video doctor message reinforcing the clinician's advice, 3) health education booklet, and 4) up to two 20-30 minute follow-up telephone drug use reduction coaching sessions. Control patients received usual care and cancer screening information. Primary outcome was reduction in number of days of drug use in past 30days of the highest scoring drug (HSD) on the baseline ASSIST, from baseline to 3-month follow-up. RESULTS: Controls reported unchanged HSD use between baseline and 3-month follow-up whereas Intervention patients reported reducing their use by 40% (p<0.001). In an intent-to-treat linear regression analysis, intervention patients reduced past month HSD use by 4.5 more days than controls (p<0.042, 95% CI: 0.2, 8.7). Similar significant results were found using a complete sample regression analysis: 5.2 days (p<0.03, 95% CI: 0.5, 9.9). Additionally, on logistic regression analysis of test results from 47 urine samples at follow-up, intervention patients were less likely than controls to test HSD positive (p<0.05; OR: 0.10, 95% CI: 0.01, 0.99). CONCLUSIONS: Findings support the efficacy of the QUIT brief intervention for reducing risky drug use.

Prevalence of Substance Use Among Patients of Community Health Centers in East Los Angeles and Tijuana.

BACKGROUND: Given the increased use of psychoactive substances on the United States-Mexico border, a binational study (Tijuana, Mexico-Los Angeles, USA) was conducted to identify the prevalence of substance use in primary care settings. OBJECTIVES: To compare the prevalence and characteristics of patients at risk for substance use disorders in Tijuana and East Los Angeles (LA) community clinics with special attention paid to drug use. METHODS: This was an observational, cross-sectional, analytical study, comparing substance use screening results from patients in Tijuana and LA. The settings were 2 community clinics in LA and 6 in Tijuana. Participants were 2,507 adult patients in LA and 2,890 in Tijuana eligible for WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) screening during March-October 2013. Patients anonymously self-administered the WHO ASSIST on a tablet PC in the clinic waiting rooms. RESULTS: Of eligible patients, 96.4% completed the ASSIST in Tijuana and 88.7% in LA (mean 1.34 minutes and 4.20 minutes, respectively). The prevalence of patients with moderate-to-high substance use was higher in LA than Tijuana for each substance: drugs 19.4% vs. 5.7%, alcohol 15.2% vs. 6.5%, tobacco 20.4% vs. 16.2%. LA patients born in Mexico had 2x the odds and LA patients born in the United States had 6x the odds of being a moderate-to-high drug user compared to Tijuana patients born in Mexico. CONCLUSIONS: Moderate-to-high drug use is higher in LA than in Tijuana but rates are sufficiently high in both to suggest that screening for drug use (along with alcohol and tobacco use) should be integrated into routine primary care of community clinics in both cities.