Holistic Assessment of Tulsa Children’s Health

Overview

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, we 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 four groups for the intervention; the control group will receive treatment as usual. Participants assigned to one of the three treatment groups will either receive fetal Doppler monitors to listen to their babies' heartbeats for one minute per day over a two-week period; receive texted attachment exercises; or will be assigned to both interventions. 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. Participants will also be asked for a saliva sample for biochemical validation of smoking via cotinine levels, a biomarker for nicotine. 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.

Full Title of Study: “Holistic Assessment of Tulsa Children’s Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: January 2022

Detailed Description

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, we 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, we 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 four groups for the intervention; the control group will receive treatment as usual. Participants assigned to one of the three treatment groups will either receive fetal Doppler monitors to listen to their babies' heartbeats for one minute per day over a two-week period; receive texted attachment exercises; or will be assigned to both interventions. 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. Participants will also be asked for a saliva sample for biochemical validation of smoking via cotinine levels, a biomarker for nicotine. The 2-week intervention will be conducted within two weeks following Assessment 1. Participants will then be asked to complete a follow-up survey and saliva assessment 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 inexpensive fetal Doppler monitors, 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.

Interventions

  • Behavioral: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)
    • Participants will be randomly assigned into one of four groups for the BLOOM intervention; the control group will receive treatment as usual. Participants assigned to one of the three treatment groups will either receive fetal Doppler monitors to take home; receive texted attachment exercises to complete from home; or both. The intervention will take place over a 2-week period. Participants in the “Doppler only” group will be asked to listen to their babies’ heartbeats for one minute per day over the 2-week period. Participants in the “Attachment Exercises Only” 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.). Participants in the “Doppler and Attachment Exercises” group will be asked to complete both activities.

Arms, Groups and Cohorts

  • No Intervention: No intervention
    • Participants in the “No intervention” group will receive treatment (e.g., prenatal care) as usual.
  • Experimental: Doppler Only
    • Participants in the “Doppler Only” group will be checked out fetal Doppler monitors at their first prenatal visit during the 2nd trimester. They will be trained on how to use the monitors and will be asked to listen to their babies’ heartbeats for one minute per day over a 2-week period. They will receive daily reminders via text.
  • Experimental: Attachment Exercises Only
    • Participants in the “Attachment Exercises Only” 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.).
  • Experimental: Doppler and Attachment Exercises
    • Participants in this group will engage in both the Doppler and Attachment exercises over the 2-week intervention period.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from Baseline Cotinine Status at 4 months
    • Time Frame: Through study completion, an average of 1 year
    • Salivary cotinine level, used to validate self-reported smoking behavior

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oklahoma State University
  • Collaborator
    • Oklahoma Center for the Advancement of Science and Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karina M Shreffler, PhD, Principal Investigator, Oklahoma State University
  • Overall Contact(s)
    • Karina M Shreffler, PhD, 918-594-8389, karina.shreffler@okstate.edu

References

Cranley MS. Development of a tool for the measurement of maternal attachment during pregnancy. Nurs Res. 1981 Sep-Oct;30(5):281-4.

Wise A, Geronimus AT, Smock PJ. The Best of Intentions: A Structural Analysis of the Association between Socioeconomic Disadvantage and Unintended Pregnancy in a Sample of Mothers from the National Longitudinal Survey of Youth (1979). Womens Health Issues. 2017 Jan – Feb;27(1):5-13. doi: 10.1016/j.whi.2016.10.006. Epub 2016 Nov 29.

Massey SH, Bublitz MH, Magee SR, Salisbury A, Niaura RS, Wakschlag LS, Stroud LR. Maternal-fetal attachment differentiates patterns of prenatal smoking and exposure. Addict Behav. 2015 Jun;45:51-6. doi: 10.1016/j.addbeh.2015.01.028. Epub 2015 Jan 20.

Shreffler KM, Tiemeyer S, Ciciolla L, Croff JM. Effect of a mindfulness-based pilot intervention on maternal-fetal bonding. Int J Womens Health. 2019 Jun 21;11:377-380. doi: 10.2147/IJWH.S203836. eCollection 2019.

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