Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMicrogen LLC
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Providing informed consent;
Ability to read and speak English
Pregnant at 14-20 weeks gestation with one fetus, intrauterine pregnancy, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
Self-identification as African American or Hispanics
Disqualifiers
Major systemic infections such as HIV, hepatitis
<18 years of age or >45 years of age
Enrollment in a prenatal program such as the Nurse Family Partnership
Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
Trial design
Design model
Parallel
Treatments tested in this trial
The Mastery Lifestyle Intervention
BehavioralCombination cognitive behavioral intervention of phase 3 CBT using ACT and PST
Treatment groups
238 Participants
are divided into 2 treatment groupsGroup A: MLI Experimental groupExperimental treatment 1 intervention
Group B: Control usual prenatal careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety
Self Report questionnaire GAD-7
Time frame
Assessing change over time: 14-20 weeks, 21-27 weeks, 32-36 weeks pregnant2
Depression
Self Report questionnaire CES-D
Time frame
Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant3
Stress
Self Report questionnaire-PSS
Time frame
Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnant4
Coping levels
Self Report questionnaire The Brief Cope
Time frame
Assessing change over time:14-20 weeks, 21-27 weeks, 32-36 weeks pregnantSecondary outcomes
1
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.
Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time frame
Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation2
To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.
Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time frame
Assessing change over time:14-20 weeks gestation, 21-27 weeks gestation3
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.
Time frame
Assessing change over time:14-20 weeks gestation, 21-27 weeks gestationOther outcomes
1
To explore the effect of the MLI on infant gestational age at birth
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time frame
After delivery2
To explore the effect of the MLI on infant birthweight
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time frame
After Delivery3
To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time frame
After DeliverySponsors and contacts
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Source ClinicalTrials.gov