The Project Wellness Pilot Feasibility Randomized Controlled Trial

The University of Tennessee, Knoxville

Status: Completed

Conditions: Diabetes, Gestational

Treatments: Other: Wellness Education; Behavioral: Physical Activity Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04209348

UTGSM-04547

K01DK105106 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Physical Activity Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Intervention

Wellness Education

Active Comparator group

Description:

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).

Treatment:

Other: Wellness Education