Project Wellness Pilot Trial
Study Details
Study Description
Brief Summary
This pilot feasibility randomized controlled trial will be conducted among women at risk for or diagnosed with gestational diabetes (GDM) at the University of Tennessee Medical Center Knoxville (UTMC). 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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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 Names:
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| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Physical Activity (PA) [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 assessed by ActiGraph device
- Neonatal size (e.g., weight and length for gestational age) [Within 4 days of birth]
Weight for gestational age (percentile), Length for gestational age (percentile)
- Maternal glycemic profile [Up to 11 weeks]
Assessed by CGM: change in percentage of time in range, in hyperglycemia and in hypoglycemia, mean/median glucose and glucose variability
- Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm) [Within 4 days of birth]
Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm)
- Skinfolds [Within 4 days of birth]
Flank, thigh, triceps, bicep and subscapular skinfolds caliper measurements to assess neonatal body composition
Secondary Outcome Measures
- Knowledge and perceptions of, and intentions for, vaccination [Up to 11 weeks]
Change assessed by questionnaire
- Intentions for contraception following delivery [Up to 11 weeks]
Among those not desiring to become pregnant in the year following delivery, change assessed by questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-40 years
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Singleton viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy
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Hyperglycemia after 24 weeks identified by:
One step diagnostic 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)
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hr: 180 mg/dL (10.0 mmol/L)
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hr: 153 mg/dL (8.5 mmol/L)
For the Two step diagnostic procedure, only Step 1 (i.e., at risk for GDM) is required for eligibility:
Step 1: 50-g GLT (non-fasting), with plasma glucose measured at 1-hr ≥130 mg/dL
Any other abnormal value on oral glucose tolerance testing associated with macrosomia
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English speaker and comfortable completing surveys in English (i.e., no translator needed)
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Planning to remain in the area for baby's first year
Exclusion Criteria:
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Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy
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Contraindications to exercise (i.e., 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, Ruptured membranes, Preeclampsia/pregnancy-induced hypertension, severe anemia
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Currently non-smoker
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Current illicit drug use
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Current use of daily medications known to alter insulin resistance and metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)
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Currently taking medication for polycystic ovarian syndrome (PCOS) (i.e., history of PCOS okay as long as she is not currently taking medication for PCOS)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
Sponsors and Collaborators
- The University of Tennessee, Knoxville
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Samantha F Ehrlich, PhD, Assistant Professor
Study Documents (Full-Text)
More Information
Publications
None provided.- UTGSM-04547
- K01DK105106