Back to resultsTargeted Lifestyle Change Group Prenatal Care (TLC)
Primary Purpose
Pregnancy, Gestational Diabetes
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TLC Group Prenatal Care
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Group Prenatal Care, Diabetes
Eligibility Criteria
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)
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TLC Group Prenatal Care
Traditional Prenatal Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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)
Physical activity and eating behavior
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on physical activity and eating behavior survey
Maternal gestational weight gain
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain
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
Rates of appointment attendance
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
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
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
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
Postpartum weight retention
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Postpartum 2 hour glucose tolerance testing (if applicable)
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
Insulin resistance
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin resistance (fasting and 30 min insulin).
Insulin sensitivity
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin sensitivity (fasting and 30 min insulin).
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
Neonatal gestational age at delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at 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
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
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
Neonatal APGAR score
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Neonatal cord blood analytes
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
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.
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.
Neonatal NICU admission
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Neonatal hypoglycemia
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Neonatal hematocrit
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Neonatal jaundice
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Neonatal respiratory distress syndrome
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Neonatal stillbirth
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Depression
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale
Psychosocial stress
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal stress using the perceived stress scale
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
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
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
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.
Full Information
NCT ID
NCT04090307
First Posted
August 9, 2019
Last Updated
January 27, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04090307
Brief Title
Targeted Lifestyle Change Group Prenatal Care
Acronym
TLC
Official Title
Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes
Keywords
Group Prenatal Care, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TLC Group Prenatal Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Prenatal Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TLC Group Prenatal Care
Intervention Description
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 Outcome Measure Information:
Title
Effects of TLC group prenatal care on birth weight
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Time Frame
Delivery/within 1 week of delivery
Title
Effects of TLC group prenatal care on neonatal length
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Time Frame
Delivery/within 1 week of delivery
Title
Effects on TLC group prenatal care on neonatal head circumference
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Time Frame
Delivery/within 1 week of delivery
Title
Effects of TLC group prenatal care on infant skinfold thickness
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular
Time Frame
Delivery/within 1 week of delivery
Secondary Outcome Measure Information:
Title
Maternal diagnosis of gestational diabetes
Description
Assessing maternal diagnosis of gestational diabetes using 2-step method(1-hour glucose challenge test, 3-hour glucose tolerance test, need for medication)
Time Frame
Up to the time of delivery
Title
Physical activity and eating behavior
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on physical activity and eating behavior survey
Time Frame
At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
Title
Maternal gestational weight gain
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain
Time Frame
Initial visit through 4-12 weeks postpartum
Title
Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy
Time Frame
Initial visit through 4-12 weeks postpartum
Title
Rates of appointment attendance
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
Time Frame
Up to the time of delivery
Title
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance
Time Frame
4-12 weeks postpartum
Title
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation
Time Frame
Delivery through 4-12 weeks postpartum
Title
Breastfeeding rates among those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding
Time Frame
Delivery through 4-12 weeks postpartum
Title
Postpartum weight retention
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Time Frame
Up to 12 weeks postpartum
Title
Postpartum 2 hour glucose tolerance testing (if applicable)
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
Time Frame
4-12 weeks Postpartum
Title
Insulin resistance
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin resistance (fasting and 30 min insulin).
Time Frame
Through study completion, up to 12 weeks postpartum
Title
Insulin sensitivity
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin sensitivity (fasting and 30 min insulin).
Time Frame
Through study completion, up to 12 weeks postpartum
Title
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction
Time Frame
Delivery
Title
Neonatal gestational age at delivery
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery
Time Frame
Delivery
Title
Induction of labor rates for those in TLC compared to traditional prenatal care
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor
Time Frame
Delivery
Title
Mode of delivery for those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery
Time Frame
Delivery
Title
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia
Time Frame
Delivery
Title
Neonatal APGAR score
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Time Frame
Delivery
Title
Neonatal cord blood analytes
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
Time Frame
Delivery
Title
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.
Time Frame
Delivery
Title
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.
Time Frame
Delivery
Title
Neonatal NICU admission
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Time Frame
Delivery
Title
Neonatal hypoglycemia
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Time Frame
Delivery
Title
Neonatal hematocrit
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Time Frame
Delivery
Title
Neonatal jaundice
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Time Frame
Delivery
Title
Neonatal respiratory distress syndrome
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Time Frame
Delivery
Title
Neonatal stillbirth
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Time Frame
Delivery
Title
Depression
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale
Time Frame
Enrollment through 4-12 weeks postpartum
Title
Psychosocial stress
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal stress using the perceived stress scale
Time Frame
Enrollment through 4-12 weeks postpartum
Title
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress
Time Frame
Enrollment through 4-12 weeks postpartum
Title
Determine the effect of TLC on psychosocial stress and depression using the life events checklist
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events
Time Frame
Enrollment through 4-12 weeks postpartum
Title
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety
Time Frame
Enrollment through 4-12 weeks postpartum
Title
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)
Description
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.
Time Frame
Enrollment through 4-12 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebony B Carter, MD,MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Targeted Lifestyle Change Group Prenatal Care
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