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Project Wellness GDM Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04209348
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The University of Tennessee, Knoxville

Brief Summary:
This pilot feasibility randomized controlled trial will be conducted among women diagnosed with gestational diabetes (GDM) and referred to the High Risk Obstetric Consultants (HiROC) at the University of Tennessee Medical Center Knoxville (UTMCK). The trial will be called Project Wellness. It will compare a physical activity (behavior change) intervention (i.e., walking/stepping in place) versus a general wellness intervention (e.g., health education focusing on immunizations, contraceptive options following delivery, etc.) on physical activity levels, maternal glycemic profile in the third trimester, and infant size and anthropometric measurements soon after birth (i.e., weight, length, circumference, skinfolds). It is hypothesized that the physical activity intervention will increase physical activity levels, and improve maternal glycemic profile and infant anthropometric measures at birth. It is also hypothesized that maternal glycemic profile in the third trimester will be associated with infant anthropometric measurements at birth.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Behavioral: Physical Activity Intervention Other: Wellness Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Project Wellness: A Pilot Feasibility Randomized Controlled Trial
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Physical Activity Intervention
The behavioral physical activity (PA) intervention focuses on walking, or stepping in place when it is not possible to walk (e.g., stormy weather). The primary goal of the PA intervention is to achieve at least 30 minutes per day of walking/stepping in place. The secondary goal is to use a PA tracker (e.g., the Fitbit Charge 3 provided by the intervention) to log and review walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of walking/stepping each day.
Behavioral: Physical Activity Intervention
Participants in both arms will wear the CGM (FDA-regulated device)
Other Name: STEP Up

Active Comparator: Wellness Education
The Wellness Education intervention will deliver information on mom and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., immunizations during pregnancy and encouragement to immunize the baby on schedule, postpartum contraceptive options and developing a contraceptive plan, infant car seats & safety checks).
Other: Wellness Education
Participants in both arms will wear the CGM (FDA-regulated device)
Other Name: Next Steps

Primary Outcome Measures :
  1. Physical Activity (PA) [ Time Frame: Up to 11 weeks ]
    Change in self-reported PA by questionnaire (e.g., Pregnancy Physical Activity Questionnaire, the Stanford Leisure-Time Activity Categorical Item), and change in PA by accelerometer

  2. Infant weight [ Time Frame: within 4 days of birth ]
    Weight for gestational age (percentile)

  3. Infant length [ Time Frame: within 4 days of birth ]
    Length for gestational age (percentile)

  4. Infant head circumference [ Time Frame: within 4 days of birth ]
    Infant head circumference (cm)

  5. Infant abdominal circumference [ Time Frame: within 4 days of birth ]
    Infant abdominal circumference (cm)

  6. Infant upper mid-arm circumference [ Time Frame: within 4 days of birth ]
    Infant upper mid-arm circumference (cm)

  7. Infant skinfolds [ Time Frame: within 4 days of birth ]
    Infant skinfolds at flank, thigh, triceps, bicep, and subscapular (millimeters)

Secondary Outcome Measures :
  1. Glycemic profile [ Time Frame: Up to 11 weeks ]
    For self-monitored capillary glucose, change in % of values exceeding clinical thresholds [Fasting: 95 mg/dL (5.3 mmol/L); 1-hr Postprandial: 130 mg/dL (7.2 mmol/L); 2-hr Postprandial: 120 mg/dL (6.7 mmol/L)]; for CGM, % time in range, in hyperglycemia and in hypoglycemia, mean/median glucose and glucose variability

  2. Knowledge and perceptions of, and intentions for, vaccination [ Time Frame: Up to 11 weeks ]
    Change assessed by questionnaire

  3. Intentions for contraception following delivery [ Time Frame: Up to 11 weeks ]
    Among those not desiring to become pregnant in the year following delivery, change assessed by questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Singleton viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy
  • Diagnosed with GDM between 24-28 weeks gestation by the following criteria

    o One step procedure

    75-g OGTT after an overnight fast, with plasma glucose measured fasting and at 1 and 2 hrs, and any of the following plasma glucose values are met or exceeded:

  • Fasting: 92 mg/dL (5.1 mmol/L)
  • 1 hr: 180 mg/dL (10.0 mmol/L)
  • 2 hr: 153 mg/dL (8.5 mmol/L)

    • Two step procedure

Step 1: 50-g GLT (non-fasting), with plasma glucose measured at 1 hr, if the plasma glucose level is >=130 mg/dL, proceed to a 100-g OGTT (Step 2)

Step 2: 100-g OGTT after an overnight fast, with plasma glucose measured fasting and at 1, 2, and 3 hrs, and two of the four plasma glucose measurements meet or exceed the thresholds of:

  • Carpenter-Coustan

    • Fasting: 95 mg/dL (5.3 mmol/L)
    • 1 hr: 180 mg/dL (10.0 mmol/L)
    • 2 hr: 155 mg/dL (8.6 mmol/L)
    • 3 hr: 140 mg/dL (7.8 mmol/L)
  • National Diabetes Data Group

    • Fasting: 105 mg/dL (5.8 mmol/L)
    • 1 hr: 190 mg/dL (10.6 mmol/L)
    • 2 hr: 165 mg/dL (9.2 mmol/L)
    • 3 hr: 145 mg/dL (8.0 mmol/L)

Those diagnosed by the Two Step procedure must have at least the 100-g OGTT within the 24-28 weeks' gestation window

  • Plasma glucose >=180 on 50-g, 1-hr GLT
  • Self-monitoring of capillary glucose levels for 1-week with > 20% of reported values exceeding recommended clinical thresholds:

    • Fasting: 95 mg/dL (5.3 mmol/L)
    • 1-hr Postprandial: 130 mg/dL (7.2 mmol/L)
    • 2-hr Postprandial: 120 mg/dL (6.7 mmol/L)
  • Anticipated diet controlled GDM (e.g., unlikely to be immediately put on insulin or oral agent at first HiROC visit)
  • Pre-pregnancy or early pregnancy BMI (i.e., calculated from a clinic weight measured weight at <13 weeks gestation) 18.5 - 45.0 kg/m2
  • Planning to deliver at UTMC
  • Planning to stay in Knoxville through baby's 1st birthday
  • Have smart phone or other smart device (to pair with Fitbit)

Exclusion Criteria:

  • Previously diagnosed with diabetes (i.e., Type I or Type II diabetes)
  • Contraindications to exercise (i.e., no absolute contraindications according to published recommendations for exercise during pregnancy), as follows:

    • Hemodynamically significant heart disease
    • Restrictive lung disease
    • Incompetent cervix/cerclage
    • Persistent second or third trimester bleeding
    • Placenta previa or vasa previa after 26 weeks gestation
    • Premature labor during the current pregnancy
    • Confirmed ruptured membranes
    • Preeclampsia/pregnancy-induced hypertension
  • Currently smoker
  • Current illicit drug use
  • Current use of daily medications known to alter insulin resistance and metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)
  • History of polycystic ovarian syndrome (PCOS) and currently taking medication for PCOS

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 identifier (NCT number): NCT04209348

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Contact: Samantha F Ehrlich, PhD 865-974-4663
Contact: Jill M Maples, PhD

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United States, Tennessee
The University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Samantha F Ehrlich, PhD   
Contact: Jill M Maples, PhD   
Sponsors and Collaborators
The University of Tennessee, Knoxville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Samantha F Ehrlich, PhD Assistant Professor
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Responsible Party: The University of Tennessee, Knoxville Identifier: NCT04209348    
Other Study ID Numbers: UTGSM-04547
K01DK105106 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The University of Tennessee, Knoxville:
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases