RESUMEN
INTRODUCTION: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk. METHODS: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21-65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n=175) or an intervention (n=176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months. RESULTS: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: -4.4 kg, 95% CI= -5.5, -3.3, p<0.001) and 12 months (net effect: -3.8 kg, 95% CI= -5.0, -2.5, p<0.001). Intervention participants were more likely to lose ≥5% of their baseline weight at 6 months (43% vs 6%, p<0.001) and 12 months (40% vs 17%, p<0.001). Intervention participants completing ≥80% of expected self-monitoring episodes (-3.5 kg); counseling calls (-3.0 kg); or self-weighing days (-4.4 kg) lost significantly more weight than less engaged intervention participants (all p<0.01). CONCLUSIONS: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01827800.
Asunto(s)
Consejo , Aplicaciones Móviles , Obesidad/terapia , Pérdida de Peso , Programas de Reducción de Peso/métodos , Adulto , Anciano , Diabetes Mellitus , Registros Electrónicos de Salud , Femenino , Humanos , Hiperlipidemias , Hipertensión , Masculino , Persona de Mediana Edad , Atención Primaria de Salud , Adulto JovenRESUMEN
INTRODUCTION: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. METHODS: Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months. RESULTS: Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression. CONCLUSIONS: Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.
Asunto(s)
Obesidad/terapia , Atención Primaria de Salud , Telemedicina , Poblaciones Vulnerables , Programas de Reducción de Peso/métodos , Adulto , Negro o Afroamericano , Anciano , Glucemia/metabolismo , Presión Sanguínea , Centros Comunitarios de Salud , Comorbilidad , Consejo , Diabetes Mellitus/epidemiología , Femenino , Hemoglobina Glucada/metabolismo , Objetivos , Conductas Relacionadas con la Salud , Hispánicos o Latinos , Humanos , Hiperlipidemias/epidemiología , Hipertensión/epidemiología , Lípidos/sangre , Masculino , Persona de Mediana Edad , Aplicaciones Móviles , North Carolina , Obesidad/epidemiología , Población Rural , Automanejo , Teléfono , Población Blanca , Adulto JovenRESUMEN
IMPORTANCE: Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE: To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care-based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS: Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25-34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS: The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES: Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS: Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30,000). The 12-month weight change was larger among intervention participants (mean [SD], -1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, -1.4 kg [95% CI, -2.8 to -0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, -1.7 kg; 95% CI, -3.3 to -0.2 kg). CONCLUSIONS AND RELEVANCE: A medium-intensity primary care-based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A "maintain, don't gain" approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00938535.