Holistic Assessment of Tulsa Children's Health

Study Overview
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Brief Summary
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The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy using a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 women (ages 18 or older) who are 12-16 weeks pregnant. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Pre- and post-tests will be used to assess maternal-fetal bonding and smoking before and after the intervention to allow for examination of change across pregnancy. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

Detailed Description
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Unintended pregnancy (unwanted and/or mistimed pregnancy) heightens the risk for adverse birth outcomes, including preterm birth and very low birth weight (< 1500 grams), which have significant public health costs. Despite decades spent attempting to reduce the proportion of pregnancies that are unintended, nearly half (45%) of all pregnancies are unintended. Among women living in poverty, rates of unintended pregnancy are considerably higher. In this study, investigators focus instead on the reduction of a risky maternal health practice associated with adverse birth outcomes that are more common when pregnancies are unintended: maternal prenatal smoking. The study focuses on rapidly increasing maternal-fetal bonding, a mediator of the relationship between unintended pregnancy and maternal health practices during pregnancy, through a recently piloted intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy. The proposed study will use a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 predominately low-income women (ages 18 or older) who are 12-16 weeks pregnant and planning to continue their pregnancies and be primary caregivers to their infants. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. The 2-week intervention will be conducted within two weeks following Assessment 1. Participants will then be asked to complete a follow-up survey near the beginning of their 3rd trimester to assess maternal-fetal bonding and smoking to allow for examination of change across pregnancy. Impacts of prior interventions to reduce unintended pregnancy and its associated adverse infant outcomes have been modest; reducing the negative association between unintended pregnancy and adverse outcomes through enhancing maternal prenatal attachment makes this project highly significant. This project will be the first to target maternal-fetal bonding through the use of a cellphone-based intervention designed to increase feelings of bonding through attachment and mindfulness exercises, making it highly innovative. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

Official Title
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Holistic Assessment of Tulsa Children's Health

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Between 12-16 weeks pregnant at the time of enrollment. Exclusion Criteria: Unable to communicate in either English or Spanish Planning to either terminate the pregnancy or place the baby for adoption.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Factorial Assignment
Interventional Model Description: This intervention examines whether the use of texted attachment exercises to effectively increase maternal prenatal bonding.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Participants in the No intervention group will receive treatment (e.g., prenatal care) as usual. | |
| Experimental: Attachment Exercises<br>Participants in the Attachment Exercises group will receive daily texts over the 2-week intervention period with activities to do from home that are designed to increase feelings of attachment (e.g., read a children's book aloud; sing a nursery rhyme; picture giving the baby a bath; tell the baby a story; etc.). | Behavioral: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)<br>* Participants will be randomly assigned into one of two groups for the BLOOM intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment exercises to complete from home. The intervention will take place over a 2-week period. Participants in the Attachment Exercises group will receive a text every day with an activity designed to increase feelings of attachment (e.g., read a children's book; sign a nursery rhyme; picture giving your baby a baby; tell your baby a story, etc.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Maternal-Fetal Attachment at 4 months | Maternal-Fetal Attachment Scale (MFAS) is a 24-item, Likert type, self-rated scale with five subscales (Cranley, 1981) | Through study completion, an average of 1 year | 
| Change from Baseline Self-Reported Smoking Status at 4 months | Survey questions asking about frequency, type (vaping vs. combustible); cannabis vs. tobacco; amount (relevant for vaping) | Through study completion, an average of 1 year |