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Targeted Lifestyle Change Group Prenatal Care (TLC)

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ClinicalTrials.gov Identifier: NCT04090307
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Pregnancy Gestational Diabetes Behavioral: TLC Group Prenatal Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.



Primary Outcome Measures :
  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 Outcome Measures :
  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 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.

  20. 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.

  21. Neonatal NICU admission [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission

  22. Neonatal hypoglycemia [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia

  23. Neonatal hematocrit [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit

  24. Neonatal jaundice [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice

  25. Neonatal respiratory distress syndrome [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome

  26. Neonatal stillbirth [ Time Frame: Delivery ]
    Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • ≤16 weeks' gestation
  • Two or more of the following GDM risk factors:
  • BMI≥30
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090307


Contacts
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Contact: Ebony B Carter, MD,MPH 314-362-8280 cartere@wudosis.wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ebony B Carter, MD, MPH    314-362-8280    cartere@wudosis.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ebony B Carter, MD,MPH Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04090307     History of Changes
Other Study ID Numbers: 201901030
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Group Prenatal Care
Diabetes
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications