The Project Wellness Pilot Feasibility Randomized Controlled Trial

NCT04209348 | Completed Results

• 2 other identifiers: UTGSM-04547K01DK105106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational

Keywords

Exercise; Contraception; Vaccination

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Neonatal Subscapular Skinfolds

  Within 5 days of birth

• Birthweight-for-gestational-age Z-score

  Within 5 days of birth

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

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

Wellness Education

ACTIVE COMPARATOR

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

Interventions

Physical Activity Intervention BEHAVIORAL

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'.

Also known as: Step Up Program

Physical Activity Intervention

Wellness Education OTHER

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).

Also known as: Next Steps

Wellness Education

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Related 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.

  PMID: 36088987 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Dr. Samantha Ehrlich
• Organization: The University of Tennessee, Knoxville

sehrlic1@utk.edu

510 299 8747

Study Officials

• Samantha F Ehrlich, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 24, 2019
• Study Start: August 21, 2020
• Primary Completion: September 21, 2021
• Study Completion: October 15, 2022
• Last Updated: February 12, 2024
• Results First Posted: February 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)