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

Obesity in Childhood Clinical Trial

— BAT  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03517891
• Other study ID #: A4540117
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity in Childhood
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Medical Sciences Campus	San Juan

Sponsors (3)

Lead Sponsor	Collaborator
University of Puerto Rico	Florida International University, Marshfield Clinic Research Foundation

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Per participant cost of providing the intervention	Aggregate cost of the implementation of the intervention will be determined including the direct costs of maintaining the distance learning and messaging platforms as well as the personnel cost.	1 year
Other	Dried blood spot sample collection	Participants will be offered the opportunity to donate a sample of capillary blood collected in dried blood spots. Samples will be stored for future analysis including but not limited to metabolic (nutritional biomarkers including vitamins and lipid profiles), inflammatory, oxidative stress biomarkers as well as contribute to epigenetic assessments of lifestyle intervention trials of this currently understudied and genetically admixed population.	0-1 and 12 Months
Other	Saliva and stool samples	Participants will be offered the opportunity to donate samples from their infants for microbiome and metabolome assessment in future studies. This is an optional study procedure.	0-1, 3, 6 and 12 months
Primary	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	Objective assessment of infant activity.	Infant movement and activity patterns will be evaluated using accelerometry data.	0-1 month, 6 months, 1 year
Secondary	Objective sleep measures	Accelerometry data will be analyzed to assess sleep patterns in infants.	0-1 month, 6 months, 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Infant Oral Health	We are collecting self reported data related to oral health care and dentition among infants.	1 year