Clinical trial NCT04209348: The Project Wellness Pilot Feasibility Randomized Controlled Trial
Official title: Project Wellness: A Pilot Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Exercise
Contraception
Vaccination
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-12-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Participants will also be followed through 12 months postpartum: Maternal weight and device-based and self-reported measures of physical activity will be assessed at 3, 6, 9 and 12 months postpartum, as well as the same infant size and anthropometric measurements assessed soon after delivery.

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)

1. hr: 180 mg/dL (10.0 mmol/L)
2. 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)

Primary outcomes:
measure: Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up
timeFrame: approximately 6 weeks
measure: Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up
timeFrame: approximately 6 weeks
Secondary outcomes:
measure: Neonatal Subscapular Skinfolds
timeFrame: Within 5 days of birth
measure: Birthweight-for-gestational-age Z-score
timeFrame: Within 5 days of birth
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: Assistant Professor
name: Samantha F Ehrlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehrlich SF, Rand B, Zite NB, Fortner KB, Paudel A, Peterson C, Maples J. Exploring the relationship between regular physical activity and the 24-hour glucose cycle in gestational glucose intolerance and gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Jan;228(1):100-102. doi: 10.1016/j.ajog.2022.09.004. Epub 2022 Sep 8. No abstract available.