The Project Wellness Pilot Feasibility Randomized Controlled Trial

Study Overview
=================
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.

Official Title
-----------------
Project Wellness: A Pilot Feasibility Randomized Controlled Trial

Conditions
-----------------
Diabetes, Gestational

Intervention / Treatment
-----------------
* Behavioral: Physical Activity Intervention
* Other: Wellness Education


Participation Criteria
=================
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 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 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 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Intervention<br>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<br>* Participants in both arms will wear the CGM (FDA-regulated device)<br>* Other names: STEP Up;|
| Active Comparator: Wellness Education<br>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<br>* Participants in both arms will wear the CGM (FDA-regulated device)<br>* Other names: Next Steps;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity (PA) | 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 | Up to 11 weeks | 
| Neonatal size (e.g., weight and length for gestational age) | Weight for gestational age (percentile), Length for gestational age (percentile) | Within 4 days of birth | 
| Maternal glycemic profile | Assessed by CGM: change in percentage of time in range, in hyperglycemia and in hypoglycemia, mean/median glucose and glucose variability | Up to 11 weeks | 
| Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm) | Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm) | Within 4 days of birth | 
| Skinfolds | Flank, thigh, triceps, bicep and subscapular skinfolds caliper measurements to assess neonatal body composition | Within 4 days of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and perceptions of, and intentions for, vaccination | Change assessed by questionnaire | Up to 11 weeks | 
| Intentions for contraception following delivery | Among those not desiring to become pregnant in the year following delivery, change assessed by questionnaire | Up to 11 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Contraception, Vaccination