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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK105106 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Subscapular Skinfolds | Neonatal Subscapular Skinfolds (i.e., caliper measurement to assess neonatal body composition) | Within 5 days of birth |
| 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). |
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Inclusion Criteria:
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)
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Samantha F Ehrlich, PhD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36088987 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The trial initially launched in December 2019 but closed in March 2020 due to the COVID-19 pandemic. It re-launched in August 2020. The flow chart with eligibility and recruitment metrics is therefore presented for December 2020 through September 2021, the period unaffected by research restrictions.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Physical Activity Intervention: Participants in both arms will wear the CGM (FDA-regulated device) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | MET hours per week | approximately 6 weeks |
|
Approx. 6 weeks
Note that adverse events were not collected for the neonates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samantha Ehrlich | The University of Tennessee, Knoxville | 510 299 8747 | sehrlic1@utk.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2020 | Jan 5, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2023 | Jan 5, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2021 | Nov 11, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| 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). |
|
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| Within 5 days of birth |
| BG001 | 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). Wellness Education: Participants in both arms will wear the CGM (FDA-regulated device) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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 | 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. | Posted | Mean | 95% Confidence Interval | Minutes per day of walk/run activity | approximately 6 weeks |
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|
| Secondary | Neonatal Subscapular Skinfolds | Neonatal Subscapular Skinfolds (i.e., caliper measurement to assess neonatal body composition) | Subscapular skinfolds | Posted | Mean | 95% Confidence Interval | mm | 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). | Posted | Mean | 95% Confidence Interval | Z-score | Within 5 days of birth |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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). | 0 | 10 | 0 | 10 | 0 | 10 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |