Protocol for a randomized controlled trial of mindfulness-based stress reduction to improve attentional control in older adults (HealthyAgers trial).

BACKGROUND: Mindfulness meditation is a form of mind-body intervention that has increasing scientific support for its ability to reduce age-related declines in cognitive functioning, improve affective health, and strengthen the neural circuitry supporting improved cognitive and affective health. However, the majority of existent studies have been pilot investigations with small sample sizes, limited follow-up data, and a lack of attention to expectancy effects. Here, we present the study design of a Phase I/II, efficacy trial-HealthyAgers trial-that examines the benefits of a manualized mindfulness-based stress reduction program in improving attentional control and reducing mind-wandering in older adults. METHODS: One hundred fifty older adults (ages 65-85 years) will be randomized into one of two groups: an eight-week mindfulness program or an eight-week, placebo-controlled, lifestyle education program. Behavioral and neuroimaging assessments are conducted before and after the training. Participants are then invited to booster sessions once every three months for a period of 12 months with post-intervention follow-up assessments conducted at 6-months and 12-months. The primary outcomes for the study are behavioral measures of attentional control and mind-wandering. Additional, secondary outcomes include network strength in an a priori defined neuromarker of attentional control, fluid and everyday cognition, emotion regulation strategy use, and markers of inflammation. DISCUSSION: This study will establish the efficacy of a group-based, low-cost mind-body intervention for the inter-related facets of attentional control and mind-wandering in older adults. Strengths of this study include a well-designed, placebo-controlled comparison group, use of web/mobile application to track study adherence, and longitudinal follow-up. TRIAL REGISTRATION: Clinicaltrials.gov (# NCT03626532 ). Registered August 4, 2018.

Play & Grow: prospective observational cohort of toddlers to inform obesity prevention, Columbus, Ohio, USA.

PURPOSE: Obesity prevention is increasingly focused on early childhood, but toddlers have not been well-studied, and children born preterm are frequently excluded. The Play & Grow Cohort was established to investigate child growth in relation to parent-child interactions in mealtime and non-mealtime settings. PARTICIPANTS: Between December 2017 and May 2019, 300 toddlers and primary caregivers were recruited from records of a large paediatric care provider in Columbus, Ohio, USA. This report describes recruitment of the cohort and outlines the data collection protocols for two toddler and two preschool-age visits. The first study visit coincided with enrolment and occurred when children (57% boys) were a mean (SD) calendar age of 18.2 (0.7) months. FINDINGS TO DATE: Children in the cohort are diverse relative to gestational age at birth (16%, 28-31 completed weeks' gestation; 21%, 32-36 weeks' gestation; 63%, ≥37 weeks' gestation) and race/ethnicity (8%, Hispanic; 35%, non-Hispanic black; 46%, non-Hispanic white). Caregivers enrolled in the cohort are primarily the child's biological mother (93%) and are diverse in age (range 18-54 years), education (23%, high school or less; 20% graduate degree) and annual household income (27%,