Mastery Lifestyle Intervention for Premature Birth

(MLI Trial)

Overseen By Raymond P Stowe, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Microgen LLC

Disqualifiers: HIV, Hepatitis, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 38

Duration: 6 weeks

238 Participants Needed

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. ^{2 3 4 5 6}

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

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

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):

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

Group I: MLI Experimental group Experimental Treatment 1 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 care Active Control 1 Intervention

Only data collection but no intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive interventions with low birth weight premature infants: an evaluation of their success. McCarton, CM., Wallace, IF., Bennett, FC.[2019]

A continuous home-based intervention program for mothers of very low birth weight (VLBW) preterm infants led to higher segmented fat-free mass in children compared to those receiving standard care, indicating potential benefits in body composition.

The intervention group showed a positive association between segmented fat-free mass and higher iron content, while the control group had increased visceral fat linked to higher insulin resistance, suggesting different metabolic outcomes based on the type of care received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an early intervention home-based program on body composition in preterm-born preschoolers with very low birth weight. Fernandes, RO., Bernardi, JR., da Fonseca, JD., et al.[2022]

The Cues program, designed to reduce anxiety and enhance sensitivity in mothers of very low birth weight infants, did not result in lower anxiety, depression, or stress levels compared to a control group receiving general information about infant care.

Both groups of mothers showed similar levels of interaction sensitivity with their infants, indicating that the attention provided in the control group was as effective as the specific skills training offered in the Cues program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction. Zelkowitz, P., Feeley, N., Shrier, I., et al.[2015]

Early life experiences, particularly suboptimal growth in utero followed by rapid growth in infancy, can increase the risk of metabolic diseases later in life, with mechanisms likely involving epigenetic changes.

Preterm infants are at a higher risk for long-term chronic diseases due to often inadequate nutrient intake, which can negatively impact cognitive development and overall health, emphasizing the importance of optimal nutrition and breast milk in their early care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early nutrition and later outcomes in preterm infants. Embleton, ND.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interventions to improve neurodevelopmental outcomes of children born moderate to late preterm: a systematic review protocol. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Growth and metabolic outcome in adolescents born preterm (GROWMORE): follow-up protocol for the Newcastle Preterm Birth GRowth study (PTBGS). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Preventive interventions with low birth weight premature infants: an evaluation of their success. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of an early intervention home-based program on body composition in preterm-born preschoolers with very low birth weight. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Early nutrition and later outcomes in preterm infants. [2022]