Assessment of the Effect of Postprandial Ambulation on Birth Weight Percentile in Patients With Gestational Diabetes Mellitus.
Phase: NA
Conditions: Gestational Diabetes, Pregnancy Complications, Pregnancy in Diabetic, Fetal Macrosomia
Sponsor: Women and Infants Hospital of Rhode Island

POSTPRANDIAL AMBULATION IN GESTATIONAL DIABETES | Version 3: 9.19.2022 
 
 
Project Title: The effect of postprandial ambulation on birth weight percentile in patients with gestational 
diabetes mellitus 
 
Principal investigator: Dr. Anna Whelan 
Faculty sponsor/Co-PI: Dr. Martha Kole-White 
 
1. OBJECTIVES, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE 
 
Objective: To assess the effect of postprandial ambulation on birth weight in patients with gestational 
diabetes as compared to routine activity. 
 
Background/Introduction: 
Gestational Diabetes Mellitus (GDM) affects 6-8% of pregnancies in the United States(1). Patients who 
are diagnosed with GDM are unable to maintain euglycemia due to insulin resistance, particularly 
postprandially(2). This postprandial hyperglycemia has been tied to numerous clinical outcomes including 
increased risk for hypertensive disorders, cesarean delivery, shoulder dystocia, increased birthweight and 
large for gestational age (LGA) neonates(2). The initial treatment of GDM includes lifestyle changes 
including daily exercise and adoption of the American Diabetes Association (ADA) diet(3). Exercise has 
been shown to improve glucose levels in patients with gestational diabetes(4, 5). However an optimal 
exercise regimen has yet to be established. As elevated postprandial glucose levels have been associated 
with increasing birthweight, it may be inferred that an intervention aimed to decrease postprandial 
glucose may assist in carbohydrate metabolism and thus decrease the percentage of large for gestational 
age neonates. 
 
A prior small pilot study done in Denmark assessed glucose trends in patients who exercised for 20 
minutes after each meal and showed a significant decrease in postprandial glucose. As walking is a safe, 
low-impact exercise that requires no equipment and can be done outside or inside, this would be an 
intervention that is accessible to almost all patients. At Women and Infants Hospital in the Division of 
Maternal Fetal Medicine we care for a large volume of patients with gestational diabetes and are well 
poised to assess how a simple intervention such as postprandial ambulation can impact maternal and 
neonatal outcomes.  
 
Hypothesis: We hypothesize that postprandial ambulation in patients with gestational diabetes will be 
associated with a decrease in neonatal birth percentile as compared to patients who do not ambulate 
postprandially.   
 
2. STUDY DESIGN, METHODS, AND PROCEDURES 
 
• 
Study design:  
o This is a randomized controlled trial of postprandial ambulation to decrease birthweight 
percentile in patients with GDM 
o Patients who are diagnosed with GDM and enrolled in the Diabetes in Pregnancy Program in 
the Division of Maternal Fetal Medicine at Women and Infants Hospital of Rhode Island will 
be approach for inclusion in the study. After consent is obtained, patients with GDM will be 
randomized into one of two groups.  
▪ Group 1: intervention group: 20 minutes of walking after meals 
▪ Group 2: non-intervention group: routine activity 
o Randomization will occur via computer generated randomization in blocks of 10. After 
consent is obtained (either by signing consent form on REDCap or printed form) the 
participants will open a sealed envelope which will reveal which intervention they are 

POSTPRANDIAL AMBULATION IN GESTATIONAL DIABETES | Version 3: 9.19.2022 
 
 
allocated to. They will then receive counseling specific to their group. They will be provided 
with an activity monitor and instructed on how to use as well as charge and upload data. They 
will be provided with the information from the manufacturer as well as trouble shooting 
guide. 
o As is the standard of care in this clinic, both groups would be equipped with glucometers and 
diabetic testing supplies. Both groups would receive the same diabetes and nutrition 
counseling from qualified nursing staff. Additionally, all participants will be provided with 
Bluetooth enabled pedometers. Those participants assigned to the intervention group would 
be instructed to walk for 20 minutes within the first two hours following each meal, while 
those assigned to the routine activity group will receive standard exercise counseling per 
ACOG and the ADA. 
o Patients will touch base weekly (either in person or by email) with diabetic nurse educators as 
is the standard management in this clinic. The decision to start insulin for glucose 
management will remain up to the discretion of the participant’s medical doctor. In addition 
to review of their glucose logs, patients will review activity log and pedometer data with 
research staff on a weekly or biweekly basis. 
o Delivery data will be collected on all patients including routine postpartum laboratory data. 
 
Inclusion and exclusion criteria: 
• 
Inclusion Criteria: Patients who are diagnosed with gestational diabetes and receive care at the 
Maternal Fetal Medicine Diabetes in Pregnancy Program and who are fluent in English or Spanish. 
• 
Exclusion Criteria: Pre-existing type 1 or type 2 diabetes, and those diagnosed with gestational 
diabetes in the first trimester. Patients who are either physically unable to ambulate or who have other 
contraindications to ambulation.  
 
Special Populations: 
• 
As this study is designed to evaluate the effect of ambulation on birth weight of neonates in patients 
with gestational diabetes, pregnant patients and fetuses will be involved. As light exercise (walking 
included) is recommended in pregnancy we believe this intervention to be safe and of minimal risk.  
 
Sample size calculation: Using the mean birthweight for diabetics as reported in the Hyperglycemia and 
Adverse Pregnancy Outcomes study of 3292 gm (+/- 529 gm)(6) we calculated that for an 80% power at 
an alpha of 0.05 we would need 41 participants in each group (total of 82 participants). However, to 
account for ~10% dropout rate. We will recruit a total of 90 participants. 
 
Setting: 
• 
Participants will be approached, consented and enrolled at the Women and Infants Obstetrics and 
Gynecology Care Center (OGCC) or the Women and Infants Prenatal Diagnosis Center (PDC).  
Additionally, data from delivery and postpartum course at Women and Infants Hospital of Rhode 
Island will be collected. If a participant delivers at an outside institution, the research team will 
attempt to attain the outside records (with participant permission). 
 
Recruitment methods: 
• 
Patients  who are pregnant at >20 weeks gestation and <32 weeks who are referred to the Diabetes in 
Pregnancy Program in the Division of Maternal Fetal Medicine will be recruited for this study. 
• 
A preparatory to research waiver will be requested as patients will be identified by chart review. 
• 
Patients will receive a copy of the consent form at the time or recruitment. 
 
Consent Process: 

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• 
After patients have been approached, a member of the research team will sit with them in person and 
review the consent form during their visit with the Diabetes in Pregnancy Program. 
• 
Patients will be counseled that their decision to participate will not affect their medical care. They 
will not receive compensation for their inclusion in the study but will receive a Bluetooth-enabled 
pedometer and be able to retain it after the completion of the study. 
 
Data Collection Procedures: 
• 
Demographic data will be determined via a combination of chart review and participant report. Chart 
review will also be performed to collect data on pregnancy and medical history, delivery and neonatal 
data, and postpartum glucose testing. 
• 
Data from monitoring of blood glucose will be obtained from patient recorded flowsheets which are 
scanned into the medical record.  
• 
Data on activity level (steps taking) and timing of activity will be collected from patient recorded 
flowsheets as well as from pedometer report. 
• 
Data on feasibility and acceptability will be collected after delivery. 
 
Source of Materials: 
• 
CNE Electronic health records, including scanned copies of blood glucose logs (see data abstraction 
form for full details). 
• 
Pedometer: patient recorded flowsheet and review of pedometer application data. 
• 
Feasibility measures7 
o Propotion of patients who enroll: proportion of patients who enroll out of all approached, 
eligible patients 
o Recruitment rate: number of patients successfully enrolled per month during the study 
o Time to enrollment: number of months to target sample size 
o Dropout rate: number of enrolled patients who drop out of study participation prior to 
delivery 
o Retention rate: proportion of enrolled patients who use FitBit device at least 75% of days 
from enrollment to delivery 
o Participant adherence:  
• 
Acceptability measures: 
o 3 question survey administered postpartum (see data collection addendum)7 
 
Records/Data to be reviewed: 
The PI and all research team members eligibility, obtain informed consent and perform data abstraction 
for most participants. 
 
Specimen collection and banking: 
Not applicable, no specimens will be collected 
 
3. Data management: 
Demographics, health history, pregnancy, delivery and neonatal data will be collected from the medical 
record. Blood glucose logs and pedometer data will be collected as well and entered into RedCap 
electronic data capture tools hosted at our institution.  REDCap (Research Electronic Data Capture) is a 
secure, web-based application designed to support data capture for research studies, to provide automated 
export procedures for data downloads to common statistical packages and to import data from multiple 
external sources.   
 

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All participants will be assigned a study ID when they are enrolled. Throughout the study, this ID will be 
used to link their de-identified study data to the study key which will include PHI and identifiable data 
that are collected on the data form. The remainder of the data which will by associated with the study ID 
will be collected in REDCap. The study key will be kept in a secure file in a password protected folder on 
the hospital network drive. The key will be destroyed upon completion of the manuscript. The coded data, 
however will be kept after the completion of the study for use in future research. 
 
4. Material/Specimen Management 
No specimens will be used.  
Participants will be allowed to keep their activity tracker for personal use at the end of the study. 
 
5. Provisions to monitor the data to ensure the safety of subjects 
This study is not greater than minimal risk. The risks involved are breach of confidentiality, however the 
plan for mitigation can be reviewed under the second titled “Data management”. The intervention 
involves changing the timing of the routinely prescribed activity. The activity we recommend is walking 
and is a low-intensity exercise which is supported during pregnancy both by ACOG and by the Institute 
of Medicine. We will monitor for any accidents that could occur (such as trips/slips/falls) each month by 
chart review and by following up with patients at routine prenatal appointments.  
 
6. Withdrawal of subjects 
The study participants will be told that they can voluntarily withdraw from the study at any time. The use 
of their data if already collected is described in detail in the consent form. 
 
 
7. References 
 
 
1. Moyer VA, Force USPST. Screening for gestational diabetes mellitus: U.S. Preventive Services Task 
Force recommendation statement. Ann Intern Med 2014 Mar 18;160(6):414-20. 
2. Brown J, Alwan NA, West J, Brown S, McKinlay CJ, Farrar D, et al. Lifestyle interventions for the 
treatment of women with gestational diabetes. Cochrane Database Syst Rev 2017 May 4;5:CD011970. 
3. ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol 2018 Feb;131(2):e49-
e64. 
4. Davenport MH, Sobierajski F, Mottola MF, Skow RJ, Meah VL, Poitras VJ, et al. Glucose responses to 
acute and chronic exercise during pregnancy: a systematic review and meta-analysis. Br J Sports Med 
2018 Nov;52(21):1357-66. 
5. Harrison AL, Shields N, Taylor NF, Frawley HC. Exercise improves glycaemic control in women 
diagnosed with gestational diabetes mellitus: a systematic review. J Physiother 2016 Oct;62(4):188-96. 
6. Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, et al. The 
hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy 
outcomes. Diabetes Care 2012 Apr;35(4):780-6. 
7. Larsen et al. “Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity 
Intervention for Pregnant Women with Diabetes: The Fit for Two Pilot Study.”JMIR Mhealth Uhealth. 
2020 Oct; 8(10):e18915.