The Project Wellness Pilot Feasibility Randomized Controlled Trial

Diabetes, Gestational Clinical Trial

Official title:

Project Wellness: A Pilot Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209348
• Other study ID #: UTGSM-04547
• Secondary ID: K01DK105106
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: October 15, 2022

Study information

• Verified date: January 2024
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 15, 2022
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes, Gestational

Intervention

Behavioral:
• Physical Activity Intervention
Motivational interviewing techniques helped participants set reasonable, specific, and achievable individual goals at each session: a duration (i.e., minutes) and frequency (i.e., days of the week) of walking or stepping, and potentially, a step count (i.e., a proxy for intensity). Individual goals often differed from the program goal in an effort to meet the participants 'where they are'.

Other:
• Wellness Education
The following topics were addressed: postpartum contraception, maternal immunizations, infant immunizations, car seat safety and planning for your hospital stay, and safe sleep and skin to skin. No information on PA was provided to the control group (i.e., neither encouragement for PA nor instructions to limit PA).

Locations

Country	Name	City	State
United States	The University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-reported Physical Activity (Assessed by Pregnancy Physical Activity Questionnaire) From Baseline to Follow-up	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.	approximately 6 weeks
Primary	Change in Physical Activity Assessed by ActiGraph Monitoring Device From Baseline to Follow-up	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.	approximately 6 weeks
Secondary	Neonatal Subscapular Skinfolds	Neonatal Subscapular Skinfolds (i.e., caliper measurement to assess neonatal body composition)	Within 5 days of birth
Secondary	Birthweight-for-gestational-age Z-score	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).	Within 5 days of birth