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Completed

NCT Number: NCT04090307

Targeted Lifestyle Change Group Prenatal Care

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).

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis, St Louis, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TLC Group Prenatal Care

Behavioral

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.

Primary outcomes

  1. Effects of TLC group prenatal care on birth weight

    Time frame: Delivery/within 1 week of delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams

  2. Effects of TLC group prenatal care on neonatal length

    Time frame: Delivery/within 1 week of delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm

  3. Effects on TLC group prenatal care on neonatal head circumference

    Time frame: Delivery/within 1 week of delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm

  4. Effects of TLC group prenatal care on infant skinfold thickness

    Time frame: 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 outcomes

  1. Maternal diagnosis of gestational diabetes

    Time frame: 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)

  2. Physical activity and eating behavior

    Time frame: 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

  3. Maternal gestational weight gain

    Time frame: Initial visit through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain

  4. Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP

    Time frame: Initial visit through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy

  5. Rates of appointment attendance

    Time frame: Up to the time of delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended

  6. Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care

    Time frame: 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance

  7. Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.

    Time frame: Delivery through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation

  8. Breastfeeding rates among those in TLC compared to traditional prenatal care.

    Time frame: Delivery through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding

  9. Postpartum weight retention

    Time frame: Up to 12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention

  10. Postpartum 2 hour glucose tolerance testing (if applicable)

    Time frame: 4-12 weeks Postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing

  11. Insulin resistance

    Time frame: 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).

  12. Insulin sensitivity

    Time frame: 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).

  13. Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction

  14. Neonatal gestational age at delivery

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery

  15. Induction of labor rates for those in TLC compared to traditional prenatal care

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor

  16. Mode of delivery for those in TLC compared to traditional prenatal care.

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery

  17. Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia

  18. Neonatal APGAR score

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score

  19. Neonatal cord blood analytes

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.

  20. Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.

  21. Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.

  22. Neonatal NICU admission

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission

  23. Neonatal hypoglycemia

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia

  24. Neonatal hematocrit

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit

  25. Neonatal jaundice

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice

  26. Neonatal respiratory distress syndrome

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome

  27. Neonatal stillbirth

    Time frame: Delivery

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth

  28. Depression

    Time frame: 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

  29. Psychosocial stress

    Time frame: 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

  30. Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire

    Time frame: Enrollment through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress

  31. Determine the effect of TLC on psychosocial stress and depression using the life events checklist

    Time frame: Enrollment through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events

  32. Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test

    Time frame: Enrollment through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety

  33. Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)

    Time frame: Enrollment through 4-12 weeks postpartum

    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

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

Acronym: TLC

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2019
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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