Obesity and asthma are two leading chronic diseases in children. Over 14 million children in the United States have obesity and six million have asthma. Both diseases are marked by disparities with higher rates of obesity and asthma, as well as poorer health outcomes among lower-income and racial/ethnic minoritized families. In addition, there is a pervasive pattern of inequity to access to care for both diseases in both adults and children, creating a research need to identify how to improve access to effective treatments that manage both conditions concurrently in primary care.
Obesity interventions targeting diet, physical activity and weight loss have been associated with asthma improvement, although more studies have been conducted among adults with asthma than among children with asthma. The United States Preventive Services Task Force recommends that children with obesity be offered a minimum of 26 contact hours of an intensive lifestyle intervention, but most children in the United States do not receive this treatment. Telehealth may provide an avenue for more access.
The objective of the proposed study is to evaluate whether telehealth versus in-person delivery of the evidenced-based Healthy Weight Clinic + Asthma Control Program (HWC+AC) is equally effective at reducing child body mass index (BMI) and asthma control in diverse lower income families. The study team will do this by completing the following aims:
- Evaluate the comparative effectiveness of telehealth delivery of the HWC+AC versus in-person HWC+AC (standard of care) in a two-arm, individually randomized non-inferiority trial among 500 children from lower-income, racially and ethnically diverse communities; of 6 to 17.9 years of age; and with BMI greater or equal to the 85th percentile and persistent asthma.
- Engage stakeholders pre- and during implementation to optimize and tailor the telehealth HWC+AC intervention and implementation strategies to the communities using a mixed methods approach.
In aim 1 the project team will conduct a randomized controlled trial recruiting from five MassGeneral Brigham health centers to enroll 500 children ages 6 to17.9 with a greater or equal to the 85th percentile and persistent asthma. Eligible children will be referred to the HWC+AC at their primary care site and will be randomized to video telehealth or in-person. In aim 2, the project team will use interviews and surveys of staff and parents to inform necessary modifications to the proposed implementation strategies of the HWC+AC interventions pre-implementation and to tailor it to the five health centers and communities they serve and evaluate program implementation.
The study will help answer the following questions: 1) Can telehealth remove barriers to accessing evidence-based treatment for lower-income, minoritized families? 2) What implementation strategies can best help clinicians deliver effective interventions via telehealth?
Eligibility criteria will be assessed by both the referring primary care provider and study coordinators and will include:
- Child is age 6.0 through 17.9 years at enrollment.
- Child’s BMI meets or exceeds the 85th percentile for age and sex.
- The child has persistent asthma.
- The caregiver speaks either English or Spanish.
The HWC+AC consists of individual and group visits guided by a set curriculum with a multi-disciplinary team (medical provider, dietitian and community health worker) and other tools to support behavioral change and reduce BMI and asthma, such as follow-up phone calls, educational materials, social determinants of health screening and referral and text messaging. Usual care will receive the individual and group visits in-person and the comparator will receive the individual and group visits via video telehealth.
Primary outcomes include change in BMI as reported in the electronic health record (EHR), Asthma Control Test as reported in the EHR and quality of life measured via survey at baseline, six months and 12 months. Secondary outcomes include lifestyle change, asthma emergency room utilization and hospitalization, binge eating symptoms, perceived caregiver stress, family-centered care and telehealth satisfaction (all measured via survey).
For the study, the project team will engage parent and caregiver advisors and healthcare research partners including representatives from population health, health equity, primary care, telehealth, obesity, asthma, the American Academy of Pediatrics and Medicaid. The goal of stakeholder engagement is to develop an intervention and study methods that are family-centered and meaningful to the various stakeholders. The engagement will result in the intervention and measures being acceptable and feasible and the study results being shared with key stakeholders. The team will collaborate through the convening of Stakeholder Advisory Board meetings held quarterly in years one and five and biannually in years two through four.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.