Targeted Lifestyle Change Group Prenatal Care

Pregnancy Clinical Trial

— TLC  

Official title:

Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04090307
• Other study ID #: 201901030
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 416
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy

Intervention

Behavioral:
• TLC Group Prenatal Care
TLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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