Targeted Lifestyle Change Group Prenatal Care

Not Applicable

Recruiting

• Conditions: Pregnancy; Gestational Diabetes

• Registration Number: NCT04090307
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).

Detailed Description

Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC. The objective is to conduct a randomized trial to determine the effect of TLC group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-16
• Study Start: 2019-11-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 416

Inclusion Criteria

• English speaking
• ≤16 weeks gestation
• Two or more of the following GDM risk factors:
• BMI ≥ 25
• Physical inactivity
• First degree relative with diabetes
• High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander)
• Prior infant weighing ≥ 4,000 g
• Prior GDM
• Hypertension (140/90 mm Hg or receiving treatment)
• High-density lipoprotein cholesterol level <35 mg/dL or triglycerides > 250 mg/dL
• Polycystic ovarian syndrome
• A1c ≥ 5.7%
• Impaired glucose tolerance
• Impaired fasting glucose on previous testing
• History of cardiovascular disease
• Ability to attend group prenatal visits at specified days and times
• Willingness to be randomized
• Ability to give informed consent

Exclusion Criteria

• Type 2 diabetes (eligible for Diabetes Group Care)
• Positive glucose challenge test during early pregnancy
• Multiple gestation (require extra care)
• Major fetal anomaly (require extra care)
• Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
• Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effects of TLC group prenatal care on birth weight	Delivery/within 1 week of delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Effects of TLC group prenatal care on neonatal length	Delivery/within 1 week of delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Effects on TLC group prenatal care on neonatal head circumference	Delivery/within 1 week of delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Effects of TLC group prenatal care on infant skinfold thickness	Delivery/within 1 week of delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular

Secondary Outcome Measures

Name	Time	Method
Maternal gestational weight gain	Initial visit through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain
Postpartum 2 hour glucose tolerance testing (if applicable)	4-12 weeks Postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
Neonatal gestational age at delivery	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery
Mode of delivery for those in TLC compared to traditional prenatal care.	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia
Neonatal cord blood analytes	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
Psychosocial stress	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal stress using the perceived stress scale
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress
Determine the effect of TLC on psychosocial stress and depression using the life events checklist	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.
Maternal diagnosis of gestational diabetes	Up to the time of delivery	Assessing maternal diagnosis of gestational diabetes using 2-step method(1-hour glucose challenge test, 3-hour glucose tolerance test, need for medication)
Physical activity and eating behavior	At enrollment, the last study visit/delivery, and 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on physical activity and eating behavior survey
Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP	Initial visit through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy
Rates of appointment attendance	Up to the time of delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care	4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.	Delivery through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation
Breastfeeding rates among those in TLC compared to traditional prenatal care.	Delivery through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding
Postpartum weight retention	Up to 12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Insulin resistance	Through study completion, up to 12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin resistance (fasting and 30 min insulin).
Insulin sensitivity	Through study completion, up to 12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin sensitivity (fasting and 30 min insulin).
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction
Induction of labor rates for those in TLC compared to traditional prenatal care	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor
Neonatal APGAR score	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.
Neonatal NICU admission	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Neonatal hypoglycemia	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Neonatal hematocrit	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Neonatal jaundice	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Neonatal respiratory distress syndrome	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Neonatal stillbirth	Delivery	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Depression	Enrollment through 4-12 weeks postpartum	Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States