A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial.

BACKGROUND: There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity. METHODS: We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7-11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.govNCT01642836. FINDINGS: Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference -0·25 [95% CI -0·90 to 0·40] kg/m2; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (-0·73 [-1·07 to -0·39] kg/m2, d=0.55); the same was true over 2 years (-0·63 [-1·13 to -0·14] kg/m2; d =0.33). No differential adverse events were observed. INTERPRETATION: The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities. FUNDING: US National Institutes of Health.

Evaluación de la Efectividad del Tratamiento Oftálmico con Eye Drops #2® en Pacientes con Conjuntivitis Alérgica / Evaluation of the Effectiveness of Ophthalmic treatment with Eye Drops # 2® in Patients with Allergic Conjunctivitis

El presente artículo muestra los resultados de un estudio que evaluó la efectividad de un medicamento oftálmico homeopático (Eye Drops #2®) en pacientes con conjuntivitis alérgica. 33 personas con antecedentes de respuesta positiva a la aplicación vía tópica ocular de alergeno se evaluaron a través de un modelo aleatorizado, doble ciego y controlado con placebo. Los participantes recibieron un alergeno solubilizado en dos visitas distintas, a fin de evaluar factores como la hiperemia conjuntival, epiescleral y ciliar, así como la quemosis, la hinchazón del párpado, el lagrimeo y la picazón. Luego de esto se les asignaron aleatoriamente dos frascos enmascarados con la indicación de que el contenido de uno se aplicaría en el glóbulo ocular derecho y el otro en el izquierdo (uno contenía el medicamento y el otro placebo). En una tercera visita, posterior al tratamiento, se evaluaron la comodidad y la seguridad del tratamiento, además de que se aplicó una dosis final de alergeno. Los resultados finales mostraron una reducción estadísticamente significativa de los síntomas y los signos de la conjuntivitis alérgica inducida durante la visita 3, por lo que el producto parece ser cómodo y seguro de usar. (AU)

This article presents the results of a study that evaluated the effectiveness of a homeopathic ophthalmic medication (Eye Drops #2®) in patients with allergic conjunctivitis. 33 subjects with a history of positive response to topical ocular allergen challenge were evaluated in a randomised, double-masked, placebo-controlled study. The subjects received a solubilized allergen in two different visits, to evaluate factors such as conjunctival, episcleral, and ciliary hyperemia, chemosis, eyelid swelling, tearing, and itching. After this, the subjects were randomly assigned to two masked bottles labeled right and left, one containing the active drug and the other containing a placebo. On a third visit, after the treatment, comfort and safety were assessed, and a final dose of allergen was applied. The final results showed a statistically significant reduction in the signs and symptoms of allergic conjunctivitis induced during visit 3, so the product seems to be comfortable and safe to use. (AU)

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

OBJECTIVE: To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. DESIGN: Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. PARTICIPANTS: Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. INTERVENTIONS: Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. MAIN OUTCOME MEASURE: Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. CONCLUSIONS: The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families.

Pilot study of medical-legal partnership to address social and legal needs of patients.

UNLABELLED: As a preliminary investigation of the effectiveness of medical-legal partnership in pediatrics, we conducted a 36-month prospective cohort study of the impact of clinic- and hospital-based legal services. We hypothesized that integration of legal services into pediatric settings would increase families' awareness of and access to legal and social services, decrease barriers to health care for children, and improve child health. METHODS: Health care providers referred families with legal or social needs to the Peninsula Family Advocacy Program (FAP). RESULTS: Fifty four families completed both baseline and six-month follow-up assessments. Comparison of follow-up with baseline demonstrated significantly increased proportions of families who utilized food and income supports and significantly decreased proportions of families avoiding health care due to lack of health insurance or concerns about cost. Two-thirds of respondents reported improved child health and well-being. CONCLUSIONS: This study suggests that adding an attorney to the medical team increases awareness of and access to social and legal services.

Medical-legal partnership: collaborating with lawyers to identify and address health disparities.

INTRODUCTION: Medical-legal partnerships (MLPs) bring together medical professionals and lawyers to address social causes of health disparities, including access to adequate food, housing and income. SETTING: Eighty-one MLPs offer legal services for patients whose basic needs are not being met. PROGRAM DESCRIPTION: Besides providing legal help to patients and working on policy advocacy, MLPs educate residents (29 residency programs), health care providers (160 clinics and hospitals) and medical students (25 medical schools) about how social conditions affect health and screening for unmet basic needs, and how these needs can often be impacted by enforcing federal and state laws. These curricula include medical school courses, noon conferences, advocacy electives and CME courses. PROGRAM EVALUATION: Four example programs are described in this paper. Established MLPs have changed knowledge (MLP | Boston-97% reported screening for two unmet needs), attitudes (Stanford reported reduced concern about making patients "nervous" with legal questions from 38% to 21%) and behavior (NY LegalHealth reported increasing resident referrals from 15% to 54%) after trainings. One developing MLP found doctors experienced difficulty addressing social issues (NJ LAMP-67% of residents felt uncomfortable). DISCUSSION: MLPs train residents, students and other health care providers to tackle socially caused health disparities.

Team sports for overweight children: the Stanford Sports to Prevent Obesity Randomized Trial (SPORT).

OBJECTIVE: To evaluate the feasibility, acceptability, and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children. DESIGN: Six-month, 2-arm, parallel-group, pilot randomized controlled trial. SETTING: Low-income, racial/ethnic minority community. PARTICIPANTS: Twenty-one children in grades 4 and 5 with a body mass index at or above the 85th percentile. INTERVENTIONS: The treatment intervention consisted of an after-school soccer program. The "active placebo" control intervention consisted of an after-school health education program. MAIN OUTCOME MEASURES: Implementation, acceptability, body mass index, physical activity measured using accelerometers, reported television and other screen time, self-esteem, depressive symptoms, and weight concerns. RESULTS: All 21 children completed the study. Compared with children receiving health education, children in the soccer group had significant decreases in body mass index z scores at 3 and 6 months and significant increases in total daily, moderate, and vigorous physical activity at 3 months. CONCLUSION: An after-school team soccer program for overweight children can be a feasible, acceptable, and efficacious intervention for weight control.