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Holistic Assessment of Tulsa Children's Health

NCT04158089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

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.).

Sponsors & Collaborators

  • Oklahoma Center for the Advancement of Science and Technology

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Karina M Shreffler, PhD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-07-18
Completion
2023-07-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158089 on ClinicalTrials.gov