Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

Part of paid clinical trials in Webster, Texas.

Sponsor
Microgen LLC
Study ID
NCT05012072
Status
Recruiting
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Conditions

  • Mental Health Wellness 1
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • The Mastery Lifestyle Intervention — BEHAVIORAL
    Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST

Study Details

This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 238 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.

Key Dates

Start date
Aug 1, 2021
Status verified
Jul 2025
Primary completion
Mar 9, 2026
Completion
Apr 13, 2026

Study Design

Enrollment
238 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MLI Experimental group
    6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 21-27 weeks in their prenatal care setting.
  • No Intervention: Control usual prenatal care
    Only data collection but no intervention

Primary Outcome Measure

Anxiety [ Time Frame: Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women's Specialist of PLLCWebsterTexas77598
Roberta J Ruiz, PhD
[email protected]
281-300-5265
Roberta J Ruiz, PhD
[email protected]
2813005265

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By research site
Women's Specialist of PLLC· Webster, TX

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