Obesity Clinical Trials

The long-term goal of this project is to learn whether a tailored physical activity program is practical, enjoyable, and helpful for families, and whether it has the potential to improve children's physical development and health. Before launching a large study, the research team completed several early phases to make sure the program met families' needs. First, a needs assessment was conducted with mothers to understand barriers to physical activity and what types of support would be most useful. Using this feedback, the program was refined and tested with three mother-child pairs over six weeks. Finally, there was an 18-week pilot randomized trial to examine feasibility and acceptability. Researchers are now conducting a larger randomized trial with up to 266 families. Half of the families are randomly assigned to receive the physical activity program, and half to a comparison group. The program combines fun, age-appropriate movement activities for children with practical support for parents. Sessions focus on building core movement skills such as jumping, balancing, running, and throwing, while also encouraging confidence, coordination, and enjoyment of being active. Activities can be adapted to each child's ability and home environment, making the program realistic for busy families. The program includes both in-person sessions and technology-based activities. In-person sessions provide hands-on support for learning new skills. Technology-based activities offer simple ideas families can use at home or during daily routines, such as hopping games, balance challenges, or quick movement breaks. Because parents in earlier phases wanted nutrition support, in-person sessions also includes a brief, child-friendly exposure to fruits and vegetables, along with simple recipes. A Tasting Party at the start of the program allows children to try different foods, and Veggie Meter scans at the beginning and end of the study help track changes in fruit and vegetable intake. Overall, this study will help determine whether a family-tailored physical activity program is a promising approach to improving physical activity, movement skills, and early health indicators in young children born to mothers with obesity.