Holistic Assessment of Tulsa Children's Health (HATCH)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Women's Health and Specialty Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; Participants in the "No intervention" group will receive treatment (e.g., prenatal care) as usual.
Experimental: Attachment Exercises; 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); 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.).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Oklahoma Center for the Advancement of Science and Technology
• Investigators: Principal Investigator: Karina M Shreffler, PhD, University of Oklahoma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HS1871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes: There is a plan to make IPD and related data dictionaries available. All non-identifying IPD that underlie results in a publication will be made available to researchers upon request. Due to the small size of the sample, demographic characteristics will not be shared to eliminate the possibility of participant identification. Variables that will be shared include treatment group assignment, whether or not the pregnancy was unintended, maternal-fetal attachment scale, and self-reported smoking behavior.
• IPD Sharing Time Frame: Researchers will be able to request limited (e.g., non-identifying) IPD at the time of publication.
• IPD Sharing Access Criteria: Researchers must request IPD directly from PI Shreffler for access. Data published will be uploaded to FigShare, which allows the PI to securely provide a researcher with access to the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No