Contact hours in a pediatric obesity intervention trial during COVID: Iamhealthy in the ISPCTN

ABSTRACT

Background: Pediatric obesity interventions of 26 or more contact hours may be more effective than those with fewer contact hours, but research is inconclusive. Disagreement may be due to the lack of uniformity in reporting dose. To remedy this issue experts recommend reporting dose intended, dose delivered, and dose received. Also, very little is known about the accumulation of dose in rural populations, and no information has been published regarding the accumulation of dose in the time of COVID 19. The purpose of the current is to describe the accumulation of dose in a four-state pediatric obesity intervention trial that was conducted in the IDeA States Pediatric Clinical Trials Network. Methods: Rural medical clinics located in four states participated. Each clinic targeted recruitment of 28 children from rural areas who were 6-11 years of age with a BMI%ile≥85th and their primary caregivers who (after consent/assent) were randomly assigned to a monthly newsletter only condition or to the iAmHealthy mHealth intervention, which was composed of 12 weekly and 3 monthly one hour group sessions and 11 hours of individual family health coaching. The 6-month intervention period began on August 24, 2020 and completed on February 7, 2021 when the impact of the COVID 19 pandemic was high in participating sites. Results: 52 of the 104 randomized participants were assigned to iAmHealthy;87% (n = 45) of these participants were retained through the final measurement. Dose intended was 26 contact hours (15 hours of group sessions and 11 hours of health coaching sessions), with a goal for families to receive 80% of these hours (20.8 hours). Dose delivered by the intervention team included 15 hours of group sessions and up to 17 hours for health coaching sessions. Dose received varied widely for both group (0.73-16.78;X = 10.65) and health coaching sessions (0.45-16.85;X = 8.21). Therefore, total accumulated contact hours varied as well (2.45-31.13;X = 18.86). Two thirds of the retained participants met the a priori dose goal of 20.8 contact hours. Conclusions: Dose intended and dose received were highly concordant, but dose received varied widely by participant. Future research should continue to explore these measures of dose, especially in underserved populations, and whether these factors are related to health behavior outcomes and body mass changes.