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

NCT03517891 | Unknown

• 1 other identifier: A4540117
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Physical activity; Sleep pattern; Nutrition; Education

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

WIC +

EXPERIMENTAL

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.

Behavioral: WIC+

WIC Standard of care (Control)

NO INTERVENTION

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.

Interventions

WIC+ BEHAVIORAL

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.

WIC +

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• We will recruit pregnant women age 18 years and older who are participants of the WIC program that:
• are in the 3rd trimester,
• intend to enroll their infant in the WIC program when he/she is born,
• are experiencing singleton pregnancies;
• agree to participate independently of the assigned group; and 5) can read and have access to the internet.

You may not qualify if:

• We will exclude pregnant women that:
• report high risk pregnancies (history of hypertension of any type, diabetes of any type, antenatal diagnosis of intrauterine growth failure or major congenital anomalies);
• who plan to leave their WIC clinic within the study time frame; and
• a history of emotional or mental health disorders that would preclude active participation in the study. Also newborns who are premature (before week 37 of gestation), with developmental disabilities, with severe conditions such as hypoxic ischemic encephalopathy, feeding disorders, intractable seizures or any other severe neurologic or muscular disorders and metabolic diseases that require specialized diet, and those requiring prolonged hospitalization at birth (\>7 days) will also be excluded from participation once the diagnosis is achieved.

Sponsors & Collaborators

• University of Puerto Rico: lead
• Marshfield Clinic Research Foundation: collaborator
• Florida International University: collaborator

Study Sites (1)

University of Puerto Rico Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 33099015 BACKGROUND

• 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.

  PMID: 40120064 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Maribel Campos, MD MSc MBA

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

• Cristina Palacios, PhD MS

  Florida International University

  PRINCIPAL INVESTIGATOR

• Jeremy Pomeroy, PhD

  Marshfield Clinic Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will use a random allocation process for each clinic with the exception of the 2 satellite clinics which will be randomly assigned separately to ensure assignment of 1 satellite clinic per treatment arm. Additional attention to the distribution of the satellite clinics is deemed necessary as the flow of participants at these sites differs from other clinics due to extended working hours and location of facilities (shopping malls). Randomization will take into account the number of pregnant participants per clinic as well as breastfeeding statistics as an important determinant of future infant obesity. Changes in clinic location and service hours have been documented during the course of the study to account for operational changes implemented by our community partner in response to extraordinary events.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized controlled trial in 16 WIC clinics. We will randomly assign 8 clinics to the intervention arm and 8 to control (usual care) arm. The intervention will combine key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyles beginning at birth until the infant is 12 months of age. Participants will be recruited at the WIC clinics during in the last trimester of pregnancy. The primary, intention-to-treat, analysis will evaluate the effect of the intervention on excessive weight gain and rate of weight gain from birth until 12 months. The intention-to-treat approach will allow us to evaluate the expected effect of adding the proposed intervention to the current WIC curriculum. Secondary analyses will include effects of the intervention on objective measures of infant activation, sedentary behaviors and sleep, diet quality, and feeding practices.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 8, 2018
• Study Start: May 11, 2018
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De identified data sets and supporting documents will be made available to the scientific community once established outcomes measures have been published.
• Access Criteria: Research proposal must be approved by the PIs and the University of Puerto Rico Medical Sciences Campus Institutional Review Board (UPR-MSC IRB). We will only provide access to de-identified data required to address the proposed research goals. We will make the data, repository samples and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Criteria are subject to review. PIs will publish any additional requirements or criteria associated to the management of data request as emerging regulations or resource limitations might require revision of this plan.

Locations

PR (1)