Reducing obesity through play: A randomized control trial - 1 ABSTRACT 2 Obesity and related chronic diseases that result from years of poor diet and physical activity (PA) may be 3 prevented by wellness programs for toddlers (18–36 months) and their parents. It is difficult to engage families 4 in such programs, but we successfully engaged a diverse (>70% African American or Hispanic) sample of parent- 5 toddler dyads in our FUNPALs Playgroup pilot study. Typical toddler obesity prevention programs instruct 6 parents to improve the nutritional quality of meals and snacks and to find ways to increase toddler physical 7 activity (e.g., WIC, SNAP Ed). However, attempts to improve toddler health behaviors are less effective if not 8 delivered within a warm and nurturing parent-child relationship, and parents are often uncertain how to feed their 9 children a healthy diet and encourage physical activity when toddlers resist (e.g., food refusal, tantrums, whining, 10 etc.). To address this need, our team, using the Intervention Mapping Framework, created the FUNPALs 11 Playgroup, which includes educational, but fun interactive programming to help parents from mostly African 12 American and Hispanic backgrounds reduce obesity risk among toddlers by addressing general parenting skills 13 in conjunction with traditional nutrition and physical activity content. Playgroups—parent-child groups that meet 14 regularly for social, physical, and educational play—present an opportunity to engage families in obesity 15 prevention efforts while offering positive parenting instruction. Our pilot study (n=50) showed toddlers in the 16 FUNPALs Playgroup, particularly those with overweight/obesity (OW/Ob; 52%), experienced desirable changes 17 in weight, diet, sleep, and parenting. The FUNPALs Playgroup was feasible and as effective or more effective 18 (e.g., reducing sugar sweetened beverages) than the standard health education control group on most 19 outcomes. Further, the FUNPALs Playgroup was superior in terms of acceptability and engagement. This study 20 will test the efficacy of the FUNPALs Playgroup to reduce obesity risk among toddlers from ethnically diverse 21 backgrounds. The central hypothesis is that the FUNPALs Playgroup will reduce obesity risk among a diverse 22 sample of toddlers more than no treatment or standard parent health education. In this multi-methods 3-arm, 23 randomized controlled trial (RCT), 340 toddlers (18-36 months) and parents from an underserved community 24 will be randomly assigned to receive: 1) 10-weekly sessions of the FUNPALs Playgroup, 2) 10-weekly sessions 25 of a standard parent health education class, or 3) no treatment. Weight status, diet, and activity will be assessed 26 at baseline (T1), 12-14 weeks after baseline (immediate post, T2), and 24-weeks after baseline (follow up, T3). 27 The RE-AIM framework will be used to determine key elements for maximizing external validity and 28 implementation. 29
