N/A Completed N=20 Randomized Double-blind Health Services Research

The Project Wellness Pilot Feasibility Randomized Controlled Trial

Diabetes, Gestational

Source: ClinicalTrials.gov NCT04209348 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcomePrimary: Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up — 0.22; -0.70 MET hours per week

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up	0.22; -0.70	—
PRIMARY Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up	0.90; -1.58	—
SECONDARY Neonatal Subscapular Skinfolds	4.37; 5.24	—
SECONDARY Birthweight-for-gestational-age Z-score	-0.87; -0.064	—

Eligibility Criteria

Inclusion Criteria

Age 18-40 years
Singleton viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy
Hyperglycemia after 24 weeks identified by:

One step diagnostic procedure 75-g Oral Glucose Tolerance Test (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)

hr: 180 mg/dL (10.0 mmol/L)
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 glucose screening test (non-fasting), with plasma glucose measured at 1-hr ≥130 mg/dL

Any other abnormal value on oral glucose tolerance testing associated with macrosomia

English speaker and comfortable completing surveys in English (i.e., no translator needed)
Planning to remain in the area for baby's first year

Exclusion Criteria

Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy
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

Currently non-smoker
Current illicit drug use
Current use of daily medications known to alter insulin resistance and metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04209348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.