Mastery Lifestyle Intervention for Premature Birth

(MLI Trial)

Recruiting at 1 trial location

Overseen By Kathryn Tart, EdD, MSN, RN

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called the Mastery Lifestyle Intervention (MLI) to reduce the risk of premature birth among pregnant women. Participants will either attend six group sessions aimed at improving emotional well-being or continue with their usual prenatal care. The trial seeks pregnant women who are 14-20 weeks along, identify as Hispanic or African American, live in the U.S., and experience high stress, anxiety, or depression. The goal is to determine if the MLI can positively affect both the mothers' stress levels and their babies' health at birth. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance prenatal care for many.

Do I need to stop taking my current medications to join the trial?

You do not need to stop taking your current medications to join the trial. The study allows participants to continue using antidepressant or anti-anxiety medications, and this will be considered in the analysis.

What prior data suggests that the Mastery Lifestyle Intervention is safe for pregnant women?

Research on the Mastery Lifestyle Intervention (MLI) lacks specific safety data for this program. This intervention focuses on teaching and support, emphasizing education and assistance rather than medications or physical treatments. Consequently, it is generally considered low-risk. The trial's lack of phase classification typically indicates no significant safety concerns are expected. Participants attend six group sessions over several weeks, designed to support healthy pregnancies. Although specific safety findings for MLI are not reported, its educational and supportive nature suggests it should be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mastery Lifestyle Intervention because it offers a fresh approach to preventing premature birth, focusing on behavior and lifestyle changes rather than medication or medical procedures. This program involves six group sessions designed specifically for pregnant Latinas and African Americans, helping them during crucial weeks of their prenatal care. Unlike traditional options that might involve medical monitoring or medication, this intervention aims to empower participants with practical skills and support, potentially improving outcomes through community and education.

What evidence suggests that the Mastery Lifestyle Intervention is effective for reducing premature birth?

Research has shown that the Mastery Lifestyle Intervention (MLI) was developed using data from over 1,000 pregnant Hispanic women to help reduce the risk of early birth. Early results suggest that programs like the MLI can enhance pregnancy health by addressing mental, social, and physical factors. In this trial, participants in the MLI experimental group will attend six group sessions designed to lower stress and improve hormone levels, which are crucial for carrying a pregnancy to full term. Although specific results for the MLI are not yet fully available, similar programs have demonstrated promise in managing stress and blood sugar, both linked to a reduced risk of early birth. ^{1 2 3 4 6}

Who Is on the Research Team?

Roberta J Ruiz, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36577949/

The mastery lifestyle intervention to reduce biopsychosocial ... Data are collected at 3 time points: enrollment (14-20 weeks gestation), following treatment (20-26 weeks), and 6 weeks after treatment (32-36 ...

2. withpower.com withpower.com/trial/phase-premature-birth-6-2021-cc9aa

Mastery Lifestyle Intervention for Premature Birth (MLI Trial) This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant ...

3. clinconnect.io clinconnect.io/trials/NCT05012072

Reducing Pregnancy Risks: The Mastery Lifestyle - ClinConnect This clinical trial, called the Mastery Lifestyle Intervention (MLI), is studying how a special program can help pregnant women reduce the risks of giving birth ...

4. trialstoday.org trialstoday.org/list/print/NCT05012072

Reducing Pregnancy Risks This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11022135/

Internet-Based Interventions for Preventing Premature Birth ... Internet-based interventions show promise in improving psychosocial health and managing blood sugar to prevent premature birth.

6. springermedizin.de springermedizin.de/the-mastery-lifestyle-intervention-to-reduce-biopsychosocial-ris/23863264

The mastery lifestyle intervention to reduce ... We propose to a) test a behavioral intervention to reduce psychosocial risks, and b) explore the impact on neuroendocrine factors and infant birth outcomes. To ...