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

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.

Conditions

• Obesity in Childhood

Interventions

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.

Sponsors & Collaborators

• Marshfield Clinic Research Foundation

  collaborator OTHER

• Florida International University

  collaborator OTHER

• University of Puerto Rico

  lead OTHER

Principal Investigators

• Maribel Campos, MD MSc MBA · University of Puerto Rico Medical Sciences Campus

• Cristina Palacios, PhD MS · Florida International University

• Jeremy Pomeroy, PhD · Marshfield Clinic Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-11

Primary Completion

2023-06-30

Completion

2024-07-31

Countries

• Puerto Rico

Study Locations