Clinical trial NCT03517891: The Baby Act Trial (BAT): a Multimodal Lifestyle Intervention
Official title: Intervention to Promote Physical Activation and Improve Sleep and Feeding Practices in Infants for Preventing Obesity Early in Life (The Baby-Act Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity in Childhood
Keywords: Physical activity
Sleep pattern
Nutrition
Education
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: Marshfield Clinic Research Foundation
name: Florida International University
First posted: 2018-05-08
Enrollment: 530
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* We will recruit pregnant women age 18 years and older who are participants of the WIC program that:

  1. are in the 3rd trimester,
  2. intend to enroll their infant in the WIC program when he/she is born,
  3. are experiencing singleton pregnancies;
  4. agree to participate independently of the assigned group; and 5) can read and have access to the internet.

Exclusion Criteria:

* We will exclude pregnant women that:

  1. report high risk pregnancies (history of hypertension of any type, diabetes of any type, antenatal diagnosis of intrauterine growth failure or major congenital anomalies);
  2. who plan to leave their WIC clinic within the study time frame; and
  3. 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.

Primary outcomes:
measure: Adequate weight gain during first year
timeFrame: one year
Secondary outcomes:
measure: Objective assessment of infant activity.
timeFrame: 0-1 month, 6 months, 1 year
measure: Objective sleep measures
timeFrame: 0-1 month, 6 months, 1 year
measure: General Infant Feeding Practices Questionnaire
timeFrame: 0-1 month, 6 months, 1 year
measure: Diet quality
timeFrame: 0-1 month, 6 months, 1 year
measure: Rate of infant growth.
timeFrame: Birth, 1 month, 6 months, 1 year
measure: Reported measures of physical activity
timeFrame: 0-1 month, 6 months, 1 year
measure: Reported measures of sleep
timeFrame: 0-1, 6 months, 1 year
measure: Weight
timeFrame: 0-1 months, 6 months, 1 year
measure: Length
timeFrame: 0-1 months, 6 months, 1 year
measure: Head Circumference
timeFrame: 0-1 months, 6 months, 1 year
measure: Social determinants of health.
timeFrame: 1 year
measure: Infant Oral Health
timeFrame: 1 year
Other outcomes:
measure: Per participant cost of providing the intervention
timeFrame: 1 year
measure: Dried blood spot sample collection
timeFrame: 0-1 and 12 Months
measure: Saliva and stool samples
timeFrame: 0-1, 3, 6 and 12 months
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Maribel Campos, MD MSc MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida International University
name: Cristina Palacios, PhD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Marshfield Clinic Research Institute
name: Jeremy Pomeroy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.