Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Effects of TLC group prenatal care on birth weight
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •≤16 weeks gestation
- •Two or more of the following GDM risk factors:
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: TLC Group Prenatal Care (Behavioral)
Traditional Prenatal Care
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.
结局指标
主要结局
Effects of TLC group prenatal care on birth weight
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Maternal diagnosis of gestational diabetes(Up to the time of delivery)
- Physical activity and eating behavior(At enrollment, the last study visit/delivery, and 4-12 weeks postpartum)
- 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(Initial visit through 4-12 weeks postpartum)
- Rates of appointment attendance(Up to the time of delivery)
- Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care(4-12 weeks postpartum)
- Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.(Delivery through 4-12 weeks postpartum)
- Breastfeeding rates among those in TLC compared to traditional prenatal care.(Delivery through 4-12 weeks postpartum)
- Postpartum weight retention(Up to 12 weeks postpartum)
- Postpartum 2 hour glucose tolerance testing (if applicable)(4-12 weeks Postpartum)
- Insulin resistance(Through study completion, up to 12 weeks postpartum)
- Insulin sensitivity(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.(Delivery)
- Neonatal gestational age at delivery(Delivery)
- Induction of labor rates for those in TLC compared to traditional prenatal care(Delivery)
- Mode of delivery for those in TLC compared to traditional prenatal care.(Delivery)
- Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.(Delivery)
- Neonatal APGAR score(Delivery)
- Neonatal cord blood analytes(Delivery)
- Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.(Delivery)
- Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.(Delivery)
- Neonatal NICU admission(Delivery)
- Neonatal hypoglycemia(Delivery)
- Neonatal hematocrit(Delivery)
- Neonatal jaundice(Delivery)
- Neonatal respiratory distress syndrome(Delivery)
- Neonatal stillbirth(Delivery)
- Depression(Enrollment through 4-12 weeks postpartum)
- Psychosocial stress(Enrollment through 4-12 weeks postpartum)
- 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 TLC on psychosocial stress and depression using the life events checklist(Enrollment through 4-12 weeks postpartum)
- 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 TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)(Enrollment through 4-12 weeks postpartum)