238 Participants Needed

Mastery Lifestyle Intervention for Premature Birth

(MLI Trial)

RJ
RP
Overseen ByRaymond P Stowe, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Microgen LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What safety data exists for the Mastery Lifestyle Intervention for premature birth?

The provided research does not contain specific safety data for the Mastery Lifestyle Intervention (MLI) or any similar interventions under different names. The studies focus on various interventions for preterm infants, but none specifically mention MLI or provide safety data related to it.1

Is The Mastery Lifestyle Intervention a promising treatment for premature birth?

Yes, The Mastery Lifestyle Intervention (MLI) is promising because it focuses on improving lifestyle factors like diet and physical activity, which are important for the health of preterm infants. These factors can help prevent long-term health issues and improve growth and development.23456

What is the purpose of this trial?

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.

Research Team

RJ

Roberta J Ruiz, PhD

Principal Investigator

Microgen Laboratories LLC

Eligibility Criteria

This trial is for pregnant women aged 18-45, of Mexican heritage or African American, with government insurance. They must be at 14-20 weeks gestation with one fetus and show signs of stress or anxiety. Excluded are those under 18, in certain prenatal programs, with severe cognitive issues, unable to read English/Spanish, or have major infections like HIV.

Inclusion Criteria

Born in Mexico or U.S. born and currently living in the U.S.
Providing informed consent
Intrauterine pregnancy
See 6 more

Exclusion Criteria

I do not have major infections like HIV or hepatitis.
I am under 18 years old.
After initial review of the electronic health record (EHR):
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Mastery Lifestyle Intervention (MLI) over 6 group sessions

6 weeks
6 group sessions

Follow-up

Participants are monitored for changes in anxiety, depression, stress, and coping levels

5-9 weeks
Assessments at 32-36 weeks pregnant

Post-delivery Follow-up

Health outcomes of infants are assessed after delivery

After delivery

Treatment Details

Interventions

  • The Mastery Lifestyle Intervention
Trial Overview The Mastery Lifestyle Intervention (MLI) aims to reduce preterm birth risks through a psychoeducational program over six sessions compared to standard care. The study will measure hormone levels and infant outcomes at delivery among the participants.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MLI Experimental groupExperimental Treatment1 Intervention
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.
Group II: Control usual prenatal careActive Control1 Intervention
Only data collection but no intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Microgen LLC

Lead Sponsor

Trials
2
Recruited
480+

Findings from Research

Moderate to late preterm infants (MLPT), who make up 84% of preterm births, face a 2-3 times higher risk of neurodevelopmental impairment compared to full-term infants, highlighting the need for targeted early interventions.
This systematic review aims to evaluate the effectiveness of early childhood interventions on cognitive, neurobehavioural, and motor development in MLPT children from birth to 4 years, with outcomes assessed up to 18 years, emphasizing the importance of long-term follow-up in this population.
Interventions to improve neurodevelopmental outcomes of children born moderate to late preterm: a systematic review protocol.Agyeman-Duah, J., Kennedy, S., O'Brien, F., et al.[2021]
The GROWMORE study, part of the Newcastle Preterm Birth Growth Study, involves 247 preterm infants and aims to investigate how early life nutrition and growth affect metabolic outcomes in adolescence, with follow-ups until 13 years of age.
This research will utilize advanced techniques, including body composition analysis and metabolic biomarkers, to explore the relationship between early life exposures and later health, highlighting the importance of targeted interventions for preterm infants.
Growth and metabolic outcome in adolescents born preterm (GROWMORE): follow-up protocol for the Newcastle Preterm Birth GRowth study (PTBGS).Wood, CL., Tinnion, RJ., Korada, SM., et al.[2022]
Interventions for low birthweight (LBW) premature children have shown only modest success in improving neurodevelopmental outcomes, despite facilitating better parent-child interactions.
A detailed review of 19 intervention programs, including the Infant Health and Development Program, highlights the need for future research to focus on long-term developmental effects and to replicate successful strategies across different settings.
Preventive interventions with low birth weight premature infants: an evaluation of their success.McCarton, CM., Wallace, IF., Bennett, FC.[2019]

References

Interventions to improve neurodevelopmental outcomes of children born moderate to late preterm: a systematic review protocol. [2021]
Growth and metabolic outcome in adolescents born preterm (GROWMORE): follow-up protocol for the Newcastle Preterm Birth GRowth study (PTBGS). [2022]
Preventive interventions with low birth weight premature infants: an evaluation of their success. [2019]
The impact of an early intervention home-based program on body composition in preterm-born preschoolers with very low birth weight. [2022]
The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction. [2015]
Early nutrition and later outcomes in preterm infants. [2022]
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