The Project Wellness Pilot Feasibility Randomized Controlled Trial

Not Applicable

Completed

Conditions: Diabetes, Gestational

Interventions: Behavioral: Physical Activity Intervention
Other: Wellness Education

Registration Number: NCT04209348

Lead Sponsor: The University of Tennessee, Knoxville

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 20

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	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.
Wellness Education	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).

Primary Outcome Measures

Name	Time	Method
Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up	approximately 6 weeks	Change in self-reported moderate to vigorous intensity walking or running activity within the sports \& exercise domain, as assessed by Pregnancy Physical Activity Questionnaire (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and Validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004;36(10):1750-1760.
Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up	approximately 6 weeks	Change in minutes per day of walk/run activity, as assessed by ActiGraph monitoring device (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Hibbing PR, Lamunion SR, Kaplan AS, Crouter SE. Estimating Energy Expenditure with ActiGraph GT9X Inertial Measurement Unit. Med Sci Sports Exerc. May 2018;50(5):1093-1102.

Secondary Outcome Measures

Name	Time	Method
Neonatal Subscapular Skinfolds	Within 5 days of birth	Neonatal Subscapular Skinfolds (i.e., caliper measurement to assess neonatal body composition)
Birthweight-for-gestational-age Z-score	Within 5 days of birth	Birthweight-for-gestational-age Z-score based on the sex- and gestational-age-specific birth-weight distributions of the 2017 U.S. Natality files. Z-scores more extreme than -1.645 and +1.645 indicate birthweight-for-gestational-age-and-sex at \<10th and \>90th percentiles, respectively, and thus indicate increased risks for adverse health outcomes (as the relationship is U-shaped). A Z-score of 0 represents birthweight-for-gestational-age-and-sex at the 50th percentile. Reference: Aris IM, Kleinman KP, Belfort MB, Kaimal A, Oken E. A 2017 U.S. Reference for Singleton Birth Weight Percentiles Using Obstetric Estimates of Gestation. Pediatrics. Jul 2019;144(1).