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The Project Wellness Pilot Feasibility Randomized Controlled Trial

Primary Purpose

Diabetes, Gestational

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Activity Intervention

Wellness Education

About this trial

This is an interventional health services research trial for Diabetes, Gestational focused on measuring Exercise, Contraception, Vaccination

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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 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)

Sites / Locations

The University of Tennessee Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical Activity Intervention

Wellness Education

Arm 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.

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).

Outcomes

Primary Outcome Measures

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

Neonatal size (e.g., weight and length for gestational age)

Weight for gestational age (percentile), Length for gestational age (percentile)

Maternal glycemic profile

Assessed by CGM: change in percentage of time in range, in hyperglycemia and in hypoglycemia, mean/median glucose and glucose variability

Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm)

Skinfolds

Flank, thigh, triceps, bicep and subscapular skinfolds caliper measurements to assess neonatal body composition

Secondary Outcome Measures

Knowledge and perceptions of, and intentions for, vaccination

Change assessed by questionnaire

Intentions for contraception following delivery

Among those not desiring to become pregnant in the year following delivery, change assessed by questionnaire

Full Information

NCT ID

NCT04209348

First Posted

December 13, 2019

Last Updated

May 11, 2023

Sponsor

The University of Tennessee, Knoxville

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04209348

Brief Title

The Project Wellness Pilot Feasibility Randomized Controlled Trial

Official Title

Project Wellness: A Pilot Feasibility Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 21, 2020 (Actual)

Primary Completion Date

September 21, 2021 (Actual)

Study Completion Date

October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Tennessee, Knoxville

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Gestational

Keywords

Exercise, Contraception, Vaccination

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity Intervention

Arm Type

Experimental

Arm Description

Arm Title

Wellness Education

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity Intervention

Other Intervention Name(s)

STEP Up

Intervention Description

Participants in both arms will wear the CGM (FDA-regulated device)

Intervention Type

Other

Intervention Name(s)

Wellness Education

Other Intervention Name(s)

Next Steps

Intervention Description

Participants in both arms will wear the CGM (FDA-regulated device)

Primary Outcome Measure Information:

Title

Physical Activity (PA)

Description

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

Time Frame

Up to 11 weeks

Title

Neonatal size (e.g., weight and length for gestational age)

Description

Weight for gestational age (percentile), Length for gestational age (percentile)

Time Frame

Within 4 days of birth

Title

Maternal glycemic profile

Description

Assessed by CGM: change in percentage of time in range, in hyperglycemia and in hypoglycemia, mean/median glucose and glucose variability

Time Frame

Up to 11 weeks

Title

Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm)

Description

Head circumference (cm), abdominal circumference (cm), upper mid-arm circumference (cm)

Time Frame

Within 4 days of birth

Title

Skinfolds

Description

Flank, thigh, triceps, bicep and subscapular skinfolds caliper measurements to assess neonatal body composition

Time Frame

Within 4 days of birth

Secondary Outcome Measure Information:

Title

Knowledge and perceptions of, and intentions for, vaccination

Description

Change assessed by questionnaire

Time Frame

Up to 11 weeks

Title

Intentions for contraception following delivery

Description

Among those not desiring to become pregnant in the year following delivery, change assessed by questionnaire

Time Frame

Up to 11 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samantha F Ehrlich, PhD

Organizational Affiliation

Assistant Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Tennessee Medical Center

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36088987

Citation

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.

Results Reference

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The Project Wellness Pilot Feasibility Randomized Controlled Trial

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