Targeted Lifestyle Change Group Prenatal Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Behavioral: TLC Group Prenatal Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TLC Group Prenatal Care<br>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. | Behavioral: TLC Group Prenatal Care<br>* 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.<br>|
| No Intervention: Traditional Prenatal Care<br>Subjects randomized to routine care will receive their prenatal care with their primary obstetric provider. Patients are seen for 10-15 minutes every four weeks until 28 weeks' gestation, every two weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits focus on routine screening tests and prenatal care. Traditional care participants will receive a phone call once a month, until 28 weeks gestation, from a nurse practitioner to check-in on pregnancy goals, healthy eating, and exercise. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Postpartum weight retention | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention | Up to 12 weeks postpartum | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Neonatal gestational age at delivery | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery | Delivery | 
| 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 | 
| 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 | 
| 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 | 
| Neonatal APGAR score | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score | Delivery | 
| Neonatal cord blood analytes | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide. | Delivery | 
| 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 | 
| 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 | 
| Neonatal NICU admission | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission | Delivery | 
| Neonatal hypoglycemia | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia | Delivery | 
| Neonatal hematocrit | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit | Delivery | 
| Neonatal jaundice | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice | Delivery | 
| Neonatal respiratory distress syndrome | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome | Delivery | 
| Neonatal stillbirth | Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth | Delivery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Group Prenatal Care