BAT
Intervention to Promote Physical Activation and Improve Sleep and Feeding Practices in Infants for Preventing Obesity Early in Life (The Baby-Act Trial)
Sponsor study identifier
interventional
530
1 country
1
Study Start
May 11, 2018
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
July 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2018
Actual (reported)May 8, 2018
Actual (reported)May 11, 2018
Actual (reported)June 30, 2023
Actual (reported)July 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adequate weight gain during first year
The main study outcome is adequate weight gain based on gender adjusted Z score using the World Health Organization weight (kilogram) for length (centimeter) growth curves.
one year
Objective assessment of infant activity.
0-1 month, 6 months, 1 year
Objective sleep measures
0-1 month, 6 months, 1 year
General Infant Feeding Practices Questionnaire
0-1 month, 6 months, 1 year
Diet quality
0-1 month, 6 months, 1 year
Rate of infant growth.
Birth, 1 month, 6 months, 1 year
Per participant cost of providing the intervention
1 year
Dried blood spot sample collection
0-1 and 12 Months
Saliva and stool samples
0-1, 3, 6 and 12 months
The intervention consist in the implementation of an enhanced nutritional education and services model through the use of a combination of modalities to disseminate messages and educational materials framed in the health empowerment model. Each component of the intervention has been developed to provide the information consistent with the theoretical framework of the modality being used. The intervention targets the following behaviors: Infant activation, Healthy sleep patterns, Screen time, Healthy feeding practices.
Participants recruited in randomly assigned control clinics will receive the WIC program standard of care. This includes the projected implementation of a web page for the nutritional education contacts. We will update our definition of the PR WIC program standard of care upon recruitment initiation and throughout the study implementation phase. We will also document the utilization rate of the web base platform provided by WIC among the control participants to determine baseline use of distance learning platforms.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067, Puerto Rico
Campos M, Pomeroy J, Mays MH, Lopez A, Palacios C. Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design. Contemp Clin Trials. 2020 Dec;99:106185. doi: 10.1016/j.cct.2020.106185. Epub 2020 Oct 22.
Kallis Colon MG, Lopez A, Campos Rivera M, Pomeroy J, Palacios C. Baby-Act Intervention to Prevent Excessive Infant Weight Gain: Development, Implementation, Lessons Learned, and Future Applications. Matern Child Health J. 2025 Apr;29(4):572-581. doi: 10.1007/s10995-025-04082-x. Epub 2025 Mar 22.
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
530 participants (actual enrollment reported by the registry).
Computerised Decision-Support Tool for Childhood Obesity Management
Contact the study team to confirm eligibility.
First Submitted
April 20, 2018
First Posted
May 8, 2018
Study Start
May 11, 2018
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
July 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 22, 2023
Record last verified: 2023-05
The proposed research will gather data on the effects of a lifestyle intervention to prevent infant obesity: self-reported socio-demographics, lifestyles, health-related variables, compliance to the intervention, anthropometrics. Results have been presented to the Center for Collaborative Health Disparities Research (CCRHD) and National Institute of Minority Health and Health Disparities (NIMHD) Officials regularly. Findings will be reported at Program Project Meetings and other scientific meetings and published in peer-reviewed journals. Data will not be disseminated outside the University of Puerto Rico until the established study outcome measures have been published. Summary data statistics, publication analysis and any other supplementary data will be posted on the Center for Collaborative Health Disparities Research.
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Source: ClinicalTrials.gov.
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