Clinical trial NCT04158089: Holistic Assessment of Tulsa Children's Health
Official title: Holistic Assessment of Tulsa Children's Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Center for the Advancement of Science and Technology
First posted: 2019-11-08
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This intervention examines whether the use of texted attachment exercises to effectively increase maternal prenatal bonding.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Maternal-Fetal Attachment at 4 months
timeFrame: Through study completion, an average of 1 year
measure: Change from Baseline Self-Reported Smoking Status at 4 months
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Women's Health and Specialty Clinic
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Karina M Shreffler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cranley MS. Development of a tool for the measurement of maternal attachment during pregnancy. Nurs Res. 1981 Sep-Oct;30(5):281-4.
citation: 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.
citation: 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.
citation: 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.