ACTIVE_NOT_RECRUITING

Targeted Lifestyle Change Group Prenatal Care

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Conditions

PregnancyGestational DiabetesGroup Prenatal CareDiabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-11-26
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04090307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking
  2. * ≤16 weeks gestation
  3. * Two or more of the following GDM risk factors:
  4. * BMI ≥ 25
  5. * Physical inactivity
  6. * First degree relative with diabetes
  7. * High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander)
  8. * Prior infant weighing ≥ 4,000 g
  9. * Prior GDM
  10. * Hypertension (140/90 mm Hg or receiving treatment)
  11. * High-density lipoprotein cholesterol level \<35 mg/dL or triglycerides \> 250 mg/dL
  12. * Polycystic ovarian syndrome
  13. * A1c ≥ 5.7%
  14. * Impaired glucose tolerance
  15. * Impaired fasting glucose on previous testing
  16. * History of cardiovascular disease
  17. * Ability to attend group prenatal visits at specified days and times
  18. * Willingness to be randomized
  19. * Ability to give informed consent
  1. * Type 2 diabetes (eligible for Diabetes Group Care)
  2. * Positive glucose challenge test during early pregnancy
  3. * Multiple gestation (require extra care)
  4. * Major fetal anomaly (require extra care)
  5. * Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
  6. * Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)

Contacts and Locations

Principal Investigator

Ebony B Carter, MD, MPH
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

Washington University in St. Louis
St Louis, Missouri, 63110
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Ebony B Carter, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-26
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2019-11-26
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Group Prenatal Care
  • Diabetes

Additional Relevant MeSH Terms

  • Pregnancy
  • Gestational Diabetes