NCT03517891

The Baby Act Trial (BAT): a Multimodal Lifestyle Intervention

Intervention to Promote Physical Activation and Improve Sleep and Feeding Practices in Infants for Preventing Obesity Early in Life (The Baby-Act Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Childhood obesity is increasing, particularly among Hispanics. Rapid weight gain during childhood increases the risk of obesity in childhood and in adulthood, also increasing the risk of chronic diseases such as diabetes and hypertension. This can be prevented with interventions during early in life that address multiple risk factors associated with the early development of obesity. Therefore, the purpose of this study is to test an intervention to promote baby activation and improve their sleep patterns and feeding patterns from birth to 12 months of age. For this purpose, pregnant women participating in the Special Nutrition Women, Infants and Children (WIC) Program in Puerto Rico will be recruited and randomly assigned to the control group (usual care within the program) or to the WIC + group (usual care + intervention). The intervention will focus on age-appropriate physical activity for children, healthy sleep and limited time on the screen, healthy dietary patterns and growth monitoring. The content will be delivered with a multimedia approach (web platform, mobile messages and telephone follow-up). If successful, this intervention could be adopted by the WIC program in Puerto Rico to help prevent childhood obesity among its participants. This will help improve the health of minorities and eliminate health disparities among Hispanics and other at-risk groups.

Detailed description

Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during critical periods of infancy increases the risk of obesity in childhood, continuing into adulthood. This could be prevented through multifaceted programs that address multiple risk factors (e.g., physical activity, sleep, eating behaviors and parental skills). Evidence on successful lifestyle interventions for childhood obesity prevention often promote a comprehensive approach delivered at multiple levels (i.e., individual, family, and community) and delivered through population-level programs. One such program is The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC serves low-income women who are pregnant and/or have infants and/or young children, groups that are among those at the greatest risk of early weight gain. Our long-term goal is to prevent infant obesity through a structured curriculum that provides a combination of key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyle (i.e., developmentally appropriate exercises for 'infant activation', sleep and healthy eating behavior) beginning at birth. The proposed intervention is an integrated novel approach leveraging current WIC outreach practices and technology for complementing the current standard of care of the WIC Program. The investigators will assess the clinical effectiveness of this novel complementary intervention among caregivers of infants (0 and 12 months) who are participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 20 WIC clinics located within the San Juan Metropolitan Area of Puerto Rico. In this design, an equal number of clinics will be randomized to the control or intervention arm. The lifestyle intervention will focus on age-appropriate infant's physical activation, healthy sleep and sedentary patterns, and healthy diet quality, by improving parenting skills. Intervention content will be delivered through a combination of technology (multi-media computer-based platforms and mobile messages) and individual counseling (phone and in-person follow-up). Participation in the intervention will begin during the last trimester of pregnancy and will continue until the infant is 12 months of age. The investigators have already tested the information of such an intervention among a small group of 10 mother-infant dyads during their first year of life, with excellent acceptability. Our main outcome is infant rate of weight gain at 12 months of age. Secondary outcomes include: 1) lifestyle behaviors, such as objectively measured hours of infant movement, sedentary behaviors and sleep; 2) diet quality score (which includes breastfeeding and amount of intake of each food group); 3) other feeding practices (i.e. spoon-feeding, addition of foods to the bottle). The research plan also includes a detailed evaluation of the cost of the intervention as a modification of the current WIC curriculum.

Conditions

• Obesity in Childhood

Interventions

Type	Name	Description
BEHAVIORAL	WIC+	intervention was based on the Health Self-Empowerment Theory. It will be adapted for the web-based platform using the Persuasive Technology and Persuasive System Design models. These models focus on the human-computer interface and how technology can/is used as a persuasive tool for behavior change. We will also include Bandura's Social Cognitive Theory. The intervention will be delivered through the combination of: educational modules provided through an interactive distance learning platform designed to provide learning experiences using multiple modalities; short messaging platforms to promote adoption of healthy behaviors and use of the educational platform; one to one sessions with the interventionist over the telephone.

Timeline

• Start date: 2018-05-11
• Primary completion: 2023-06-30
• Completion: 2024-07-31
• First posted: 2018-05-08
• Last updated: 2023-11-22

Locations

1 site across 1 country: Puerto Rico