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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity in Childhood

Intervention / Treatment
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* Behavioral: WIC+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WIC +<br>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+<br>* 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.<br>|
| No Intervention: WIC Standard of care (Control)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective assessment of infant activity. | Infant movement and activity patterns will be evaluated using accelerometry data. | 0-1 month, 6 months, 1 year | 
| Objective sleep measures | Accelerometry data will be analyzed to assess sleep patterns in infants. | 0-1 month, 6 months, 1 year | 
| General Infant Feeding Practices Questionnaire | This will be assessed from the General Feeding Practices Questionnaire completed at each assessment visit. This instrument was developed to document breastfeeding practices, time of introduction of foods and the presence of other stimuli while feeding. | 0-1 month, 6 months, 1 year | 
| Diet quality | This will be measured using a validated infant Food Frequency Questionnaire, which will be completed at each assessment visit. The infant food frequency questionnaire was developed to document the food provided to infants 0 to 24 months of age. Information collected allows for calorie and nutrient content assessment and comparison to established nutritional guidelines. | 0-1 month, 6 months, 1 year | 
| Rate of infant growth. | Difference in gender and age adjusted weight for length Z scores determined using the World Health Organization growth curves at each assessment time-point will be evaluated to determine the impact of the intervention. | Birth, 1 month, 6 months, 1 year | 
| Reported measures of physical activity | Participants will be asked to complete a survey to document the activities and the time spent performing the activities taught as part of the intervention. | 0-1 month, 6 months, 1 year | 
| Reported measures of sleep | Participants will be asked to complete a survey to document characteristics of their infant's sleep pattern and duration of sleep periods. | 0-1, 6 months, 1 year | 
| Weight | The infant's weight will be documented in kilograms at every study assessment time-point and evaluated using the World Health Organization gender appropriate growth curves. | 0-1 months, 6 months, 1 year | 
| Length | The infant's Length will be documented in centimeters at every study assessment time-point and evaluated using the World Health Organization gender appropriate growth curves. | 0-1 months, 6 months, 1 year | 
| Head Circumference | As part of the growth assessment the infant's head circumference will be documented in centimeters at every study assessment time-points. | 0-1 months, 6 months, 1 year | 
| Social determinants of health. | We have added constructs of social capital to our exit interview and integrated the Accountable Health Communities Health-Related Social Needs 10-item screening tool. | 1 year | 
| Infant Oral Health | We are collecting self reported data related to oral health care and dentition among infants. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Sleep pattern, Nutrition, Education