Project Wellness: A Pilot Feasibility Randomized Controlled Trial
Phase: NA
Conditions: Diabetes, Gestational
Sponsor: The University of Tennessee, Knoxville

Official Title:  
Project Wellness: A Pilot Feasibility Randomized Controlled Trial   
 
ClinicalTrials.gov Identifier:  
NCT04209348 
 
Study Protocol date:  
10/26/2020 
 

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Project Wellness: A Pilot Feasibility Randomized Controlled Trial 
 
A. Background 
This pilot randomized controlled trial (RCT) serves to replace the original Aim 3 of 
NIDDK-K01DK105106 to Dr. Samantha Ehrlich, Physical Activity in Pregnancy for 
Intergenerational Obesity Prevention. This modified Aim 3 is well aligned with the 
award’s focus on innovative ‘upstream’ risk factors and strategies for the prevention of 
obesity.  
 
In the U.S., the prevalence of overweight or obesity among women of reproductive age 
is 59%1; among children, 17% are classified with class 1 obesity, 6% with class 2 
obesity and 2% with class 3 obesity.2 Once overweight/obese, returning to normal 
weight is difficult3-5, hence the appeal of targeting upstream, modifiable factors 
influencing the in utero environment.6 
 
Physical activity (PA) is an important component of weight loss and weight 
maintenance7, thereby contributing to the prevention of and reductions in obesity. Some 
evidence suggests that PA in pregnancy reduces excessive gestational weight gain8,9 
and postpartum weight retention, thereby reducing maternal obesity risk.10 In regards to 
the children, PA in pregnancy11 may protect against fetal overgrowth12-21 and elevated 
neonatal adiposity15,18, both risk factors for childhood obesity22,23, by mitigating maternal 
insulin resistance24 and reducing elevated postprandial glucose15,16,25-28 that result in 
fetal over-nutrition.29 PA in pregnancy may additionally result in epigenetic changes that 
impact child metabolism30-34, potentially by countering hyperglycemia-induced changes 
in DNA methylation.35-37  As such, PA in pregnancy may be a particularly effective 
strategy for women with gestational diabetes (GDM).  
 
The children of women with GDM are at increased risk of childhood obesity, across the 
spectrum of criteria currently used to diagnose GDM.38,39 Elevated postprandial glucose 
values in women with GDM are predictive of delivering a large for gestational age (LGA) 
infant12-14, a risk factor for childhood obesity23,40, and PA has been shown to reduce 

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postprandial glucose levels in women with GDM.25 A recent study of 162 women with 
GDM assessed maternal glucose throughout the day (for 7-days) with masked 
continuous glucose monitors (CGM) and reported that glucose levels were higher in 
those delivering a LGA infant, particularly overnight glucose levels.41 The children of 
women at risk for GDM (i.e., any abnormal value on oral glucose tolerance testing, such 
as those failing the 50g, 1-hr screening test ) are also at increased risk of macrosomia42 
and childhood obesity.38 
 
Outside of pregnancy, it is well-established that regular PA improves insulin action, and 
that glucose uptake may remain elevated for up 48 hours following PA.43 Increased 
scientific understanding of these processes in women at risk for or with GDM are 
desperately needed.  
 
A recent meta-analysis found that prenatal exercise is not statistically significantly 
associated with childhood obesity (i.e., percent body fat, body weight and BMI), 
although few studies examined these outcomes.44 However, to the best of my 
knowledge, no one has investigated this relationship exclusively among women at risk 
for or with GDM. It is hypothesized that a PA intervention following a failed screening 
test will increase PA levels and lower glucose values15,16,26-28,41, thereby reducing the 
risks of LGA12-21 and macrosomia42 and elevated neonatal adiposity15,18, and potentially 
accelerated infant growth45-48,  all precursors to childhood obesity.  
 
The PA intervention is based upon the same theoretical constructs and behavior 
change strategies previously used by successful weight management interventions 
targeting pregnancy and the postpartum period49-52 (and among women with GDM 
specifically49,51); all of these interventions included a PA component. Specifically, the PA 
intervention is based on Bandura’s social cognitive theory53,54 and the Transtheoretical 
model.55 Behavior change techniques52,56 include self-monitoring of and feedback on 
behavior (e.g., daily self-monitoring); goal setting; review of behavior goals (e.g., 
reviewing activity logs and modifying goals accordingly); problem solving; action 
planning; social support; prompts and cues; self-rewards (e.g., encouraging participants 

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to give themselves non-food rewards after achieving goals); providing information on 
health consequences (e.g., information on the benefits of PA during pregnancy); and 
providing information from a credible source (e.g., lifestyle coach). 
 
Walking is the most common leisure time PA reported by pregnant women57 and, for 
most adults, is an easily accessible mode of PA. As such, the PA intervention will 
specifically focus 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 for the participant 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 their 
walking/stepping, and to accumulate at least 3,000 steps during their 30 minutes of 
walking/stepping.  
 
In terms of safety, the frequency, duration and intensity of PA prescribed by the 
intervention (i.e., the PA goal) is consistent with American College of Sports Medicine’s 
(ACSM) Guidelines for exercise during pregnancy.58 In terms of frequency, ACSM 
recommends that pregnant women exercise ‘regularly’ (no specific number of days per 
week given). For previously inactive women, ACSM recommends lower intensity and/or 
duration of exercise rather than a reduced frequency of exercise, and progressively 
increasing exercise duration from 15 minutes to 30 minutes a day, most days of the 
week. In addition, as recommended by ACSM, the intervention will prescribe moderate 
intensity activity.  Women will be advised to monitor the intensity with a ‘talk test’ using 
the Omni rating of perceived exertion scale59 (0-10) to tell how hard they are working 
and to aim for ‘Somewhat hard, I can talk with some effort’. The intervention’s goal of 
3,000 steps during the 30 minutes of walking/stepping is based on previous studies of 
pregnant60 and non-pregnant adults61-63 that identify 100 steps per minute as indicative 
of moderate intensity walking.  
 
 
 

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B. Aim 
To conduct a pilot feasibility RCT among up to 48 women, either diagnosed with GDM 
and referred to the High Risk Obstetric Consultants (HiROC) at the University of 
Tennessee Medical Center Knoxville (UTMC), or at risk for GDM (e.g., failed the 50g, 1-
hr screening test) and managed by one of the clinics listed in Section J. The RCT will 
compare a physical activity (behavior change) intervention (i.e., walking/stepping in 
place) versus a general wellness intervention (i.e., health education focusing on 
immunizations, contraceptive options following delivery, etc.) on PA levels, maternal 
glycemic profile in the third trimester, and infant size and anthropometrics (i.e., weight, 
length, head, abdominal and upper mid-arm circumference, and skinfolds at the flank, 
thigh, triceps, bicep and subscapular).  
 
It is hypothesized that the PA intervention will increase PA levels during pregnancy, and 
improve maternal glycemic profile in the third trimester and infant anthropometric 
measures at birth. The exploratory hypothesis is that improvements in third trimester 
glycemic profile mediate the effect of pregnancy PA on the infant anthropometric 
measures.   
 
 
C. Study Staff 
Student research assistants working on the study (i.e., recruitment, conducting 
intervention sessions and data assessment visits) will be trained and overseen by Drs. 
Ehrlich and Maples. All will remain up to date on required IRB trainings and approvals 
(e.g., CITI trainings and UTMC outside learner approval) for the duration of their work 
on the study.   
 
 
D. Usual Care 
Usual care at HiROC for women with GDM includes bimonthly to weekly in-person 
appointments, depending on the patients’ needs and adherence to the diabetes 

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educators’ recommendations, to monitor their capillary glucose levels, provide 
counseling on diet, and prescribe or adjust medications, as needed. PA is usually 
encouraged at the first GDM appointment, but is not directly prescribed, further 
discussed or typically tracked in conjunction with usual clinical care. Women at risk for 
GDM (i.e., who fail the screening but not the diagnostic test), are not seen by HiROC for 
diabetes education.  
 
 
E. Data Assessment Overview: The Project Wellness Study Visits 
Surveys (e.g., demographic, health behaviors, medical history, dietary intake) will be 
administered at baseline (initiated < 30 weeks gestation, Study Visit 1) and at follow-up 
(initiated < 36 weeks gestation, Study Visit 2); see Table 1 for the variables to be 
assessed and timing of their assessments. PA will be objectively measured at baseline 
and follow-up with ActiGraph physical activity monitors (PAMs, i.e., the CentrePoint 
Insight Watch) worn continuously for 7 days on the dominant wrist. Continuous glucose 
monitors (CGM) will be worn continuously for 7 days on the participants’ non-dominant 
upper arm (posteriorly located) at Study Visits 1 and 2 to assess maternal glycemic 
profile (i.e., DEXCOM G6 devices, participants will be blinded to their CGM data). Infant 
outcomes [i.e., weight; length; head, abdominal and upper mid-arm circumferences; and 
skinfolds at four sites (flank, thigh, triceps, bicep and subscapular skinfolds)]18,64 will be 
assessed by study staff within 4 days of birth (i.e., the optional delivery visit).  
 
Participants will be randomized to the STEP Up intervention or the Next Steps 
intervention (described in Section R) once they have successfully completed all of the 
data assessments for Study Visit 1 (described in Section L). Intervention staff will inform 
the participants of their program assignment (i.e., STEP Up or Next Steps) and 
schedule the first intervention session. All intervention sessions will be conducted 
remotely (i.e., via phone and/or video chat). 
 
Study visits will occur either remotely (i.e., via phone and/or video chat) or take place in 
private rooms at the UT Medical Center [e.g., a private office or exam room in the High 

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Risk Obstetrical Consultants (HiROC) clinic or Preston Medical Library; and Labor and 
Delivery or the Mother/Baby Units on 3 West, 3 East, and 4 West for the delivery visit].  
 
 
F. Incentives 
Participants will receive payments in the amount of: $80 for Study Visit 1, $100 for 
Study Visit 2, and $100 for the delivery visit (i.e., $280 total). Incentive payments will be 
Walmart gift cards distributed either in person, by mail, or dropped off at the participants 
home upon completion of all of the data assessment elements associated with that Visit. 
If a gift card is sent by mail and not received, a replacement will be dropped off at the 
participants home. 
 
 
G. Parking 
Participants will receive vouchers to cover the cost of parking at the Medical Center for 
any in-person Study activities (described in Sections L, N and O; one voucher will be 
provided at the delivery visit). 

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Table 1. Variables to be measured at the study visits. 
 
 
Medical 
Chart 
 
Physician 
Screen/ 
Study Visit 1 
(≤ 30 weeks) 
 
Study 
Visit 2 
(≤ 36 
weeks) 
 
Delivery 
Visit 
 
3-month 
Infant 
Follow 
up Visit  
 
6-month 
Infant 
Follow 
up Visit 
 
9-month 
Infant 
Follow 
up Visit  
 
1-year 
Infant 
Follow 
up Visit 
Demographics 
 
 
 
 
 
 
 
 
Age 
 
X 
 
 
 
 
 
 
Race-ethnicity 
 
X 
 
 
 
 
 
 
Working status 
 
X 
X 
 
X 
X 
X 
X 
SES, Marital status, Insurance 
status 
 
X 
 
 
 
X 
 
 
Smoking, Alcohol, Illegal drugs 
 
X 
 
 
 
 
 
 
Sleep 
 
X 
X 
 
 
 
 
 
Biomedical  
 
 
 
 
 
 
 
 
Height 
X 
X 
 
 
 
 
 
 
Weight (pre-pregnancy, during 
pregnancy and postpartum) 
X 
X 
X 
 
X 
X 
X 
X 
Medical history  
 
X 
 
 
X 
X 
X 
X 
Medication use 
X 
X 
X 
 
 
 
 
 
Pregnancy history/outcomes 
X 
 
 
 
X 
 
 
 

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Prior use of and intentions for 
contraceptives 
 
X 
X 
 
 
 
 
 
Contraception initiation and 
use following delivery 
X 
 
 
 
X 
X 
X 
X 
Vaccination (flu and Tdap) 
perceptions and intentions for 
vaccination 
X 
X 
X 
 
X 
X 
X 
X 
Capillary glucose values (i.e., 
7 days of values recorded in 
purple booklets, for women 
with GDM only) 
 
X 
X 
 
 
 
 
 
Continuous Glucose 
Monitor (i.e., 7 days) 
 
X 
X 
 
 
 
 
 
Infant Anthropometrics 
 
 
 
X 
(optional) 
X 
X 
X 
X 
Infant feeding and 
immunizations 
 
 
 
 
X 
X 
X 
X 
Actigraph Physical Activity 
Monitor   
 
X 
X 
 
X 
X 
X 
X 
Food Frequency 
Questionnaire (FFQ) 
 
X 
X 
 
 
 
 
 

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Physical activity 
questionnaires 
 
X 
X 
 
X 
X 
X 
X 
Stage of change for Physical 
Activity 
 
X 
X  
 
 
 
 
 
Diabetes Risk Perception & 
Family History of Diabetes  
 
X 
 
 
 
 
 
 
Self-efficacy for Physical 
Activity 
 
X 
X  
 
X 
X  
X 
X  
Social support for Physical 
Activity 
 
X 
X 
 
X 
X  
X 
X  
Symptoms of Depression  
 
X 
X 
 
 
 
 
 
Adverse events 
 
 
X 
 
 
 
 
 
Acceptance of interventions 
 
 
X 
 
 
 
 
 

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H. Advertising the study 
The study will be advertised at local clinics affiliated with the University of Tennessee 
Medical Center [i.e., who refer patients to HiROC upon GDM diagnosis, specifically: 
University Women’s Specialists, UT Ob/Gyn Center (residents’ clinic), and University 
Midwifes]. Posters advertising the study (e.g., women at risk for or with GDM may be 
eligible, incentive payments will be given for participation, and the study staff’s contact 
information) will be hung in participating the clinics and advertised on their waiting room 
TV monitors and electronic patient portals, upon receipt of permission from the clinics’ 
leadership. A handout with more details on what participation would entail and the study 
staff’s contact information will also be available at the clinic front desks and in the labs 
(i.e., where patients are tested for GDM), and will be distributed to potentially eligible 
patients by clinic staff. Women being referred to HiROC for GDM treatment will be told 
by the clinic staff that they may be eligible for the study and asked whether they wish to 
opt out of email, telephone calls and/or text message invitations to learn more about the 
study. Women who fail the screening test (i.e., 50g, 1-hour OGT) will also be told by 
clinic staff that they may be eligible for the study and asked if interested or they would 
like to opt out. Clinic staff will inform study staff of patients opt out/permission to contact 
status via Message Center (in the EMR) or by email. Those refusing all contact with 
study staff (i.e., opt outs) will be excluded from the procedures below. 
 
 
I. Eligibility 
Women will be recruited from four clinics associated with the UT Medical Center (listed 
in Section J); all of these clinics have electronic medical record systems or are soon 
transitioning to electronic medical record systems that will be used to confirm patient 
eligibility (i.e., paper charts will be used in the interim, as needed). Study staff will pre-
screen the electronic medical records of women diagnosed with GDM who have not 
refused/opted out of contact with study staff. They will summarize their findings for the 
physician approvers (e.g., Drs. Fortner and Zite). The physician approvers will review 
these findings and the medical records before signing off on the physician approval to 
contact forms confirming the patient meets the primary eligibility criteria; at this point, a 

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Project Wellness study ID number will be assigned. Study staff will follow up with 
potentially eligible patients by email, telephone and/or text messages to distribute 
information about the study and evaluate the secondary eligibility criteria. Staff will 
arrange by telephone, email, and/or text message to meet eligible and interested 
women by Zoom or at UTMC.  
 
Primary Eligibility Criteria, Evaluated at the Physician Screening 
• Age 18-40 years 
• Not previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of 
pregnancy 
• Singleton viable pregnancy with low suspicion for clinically significant abnormality or 
aneuploidy  
• Diagnosed with GDM after 24 weeks by:  
o 
One step diagnostic procedure65 
 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:  
o Fasting: 92 mg/dL (5.1 mmol/L) 
o 1 hr: 180 mg/dL (10.0 mmol/L)  
o 2 hr: 153 mg/dL (8.5 mmol/L) 
o 
For the Two step diagnostic procedure,65,66 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 
o 
Any other abnormal value on oral glucose tolerance testing associated with 
macrosomia42 
• No contraindications to exercise (i.e., no absolute contraindications according to 
published recommendations for exercise during pregnancy67), as follows: 
o 
Hemodynamically significant heart disease 
o 
Restrictive lung disease 
o 
Incompetent cervix/cerclage 
o 
Persistent second or third trimester bleeding 
o 
Placenta previa or vasa previa after 26 weeks gestation 

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o 
Premature labor during the current pregnancy 
o 
Confirmed ruptured membranes 
o 
Preeclampsia/pregnancy-induced hypertension 
• Currently non-smoker  
• No current illicit drug use  
• No current use of daily medications known to alter insulin resistance and metabolic 
profiles (e.g., metformin, corticosteroids, anti-psychotics) 
• Not 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) 
• English speaker and comfortable completing surveys in English (i.e., no translator 
needed) 
 
Secondary Eligibility Criteria, Evaluated by Study Staff during Recruitment 
• Planning/likely to stay in Knoxville through baby’s 1st birthday 
 
 
J. Recruitment Clinics   
University Women’s Specialists: 
https://www.utmedicalcenter.org/medical-care/specialty-practices/university-womens-
specialists/ 
UT Ob/Gyn Center: 
https://utimobgyncenter.utmck.edu/portal/ut-obgyn-center/default.aspx 
University Midwifes: 
https://www.utmedicalcenter.org/medical-care/specialty-practices/university-midwives/ 
 
Women’s Care Group: 
https://www.utmedicalcenter.org/medical-care/medical-services/specialty-
practices/womens-care-group-knoxville/ 
 
 
 

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K. Recruitment at HiROC 
Study staff will also work with HiROC on study recruitment. HiROC clinic staff (e.g., 
diabetes educators) will also mention the study to potentially eligible women upon their 
referral to HiROC for GDM, and those who do not refuse/opt out of receiving more 
information about the study will be referred to study staff for follow-up. Study staff will 
pre-screen the medical records and summarize their findings for the physician 
approvers. Physician approvers will review their findings and the medical records before 
signing off on the physician approval to contact form; at this point, a Project Wellness 
study ID number will be assigned. Study staff will follow up with potentially eligible 
patients by email, telephone and/or text messages to distribute information about the 
study and evaluate the secondary eligibility criteria. Staff will arrange by telephone, 
email, and/or text message to connect with eligible and interested women for their Study 
Visit 1. Study staff will call, email, and/or text the participant to remind her of the 
scheduled day/time/modality (i.e., remote or in-person at UTMC) of her Study Visit 1.  
 
 
L. Study Visit 1 (Baseline data assessment, scheduling initiated at after 24 weeks 
and Study Visit ≤ 30 weeks gestation) 
The baseline study visit may occur remotely, via Zoom, or at UTMC. If it is a remote 
visit, all materials will have been either mailed ahead of time or dropped off at the 
participants’ home. First, study staff will explain what will be asked of study participants, 
answer any questions they may have, and obtain written informed consent. If it is a 
remote visit, the consent form will be signed via DocuSign software. Second, the 
women’s weight and height will be measured by study staff, and the ‘in-person’ survey 
completed. If it is a remote visit, a scale will be left with at the home with her other study 
materials, and a weight measurement taken during/soon after the Zoom session. 
Weight and height will also be obtained from the medical record. Third, study staff will 
explain the PAM data assessment protocol (e.g., they will be asked to wear the device 
continuously for 7 days on their dominant wrist, but if that is not possible, they are to 
record the days/times of device removal in a diary log) and give the women her PAM 

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and PAM diary log. Fourth, study staff will give the participant a Study Visit 1 at home 
survey and Food Frequency Questionnaire (FFQ), plus a number 2 pencil for the FFQ.  
 
In addition, the continuous glucose monitor will be applied to the participant. When 
possible, a telehealth visit with research staff via Zoom or telephone will be scheduled 
so they may assist the set-up (e.g., walk them through linking the transmitter device to 
their receiver) and advise on application of the CGM. 
 
 
Continuous Glucose Monitor (CGM) 
A video describing the insertion of the CGM sensor and how to attach the transmitter is 
available at: 
https://provider.dexcom.com/education-research/cgm-education-use/videos/dexcom-g6-
how-insert-sensor-attach-transmitter 
 
Information provided by Dexcom indicates that the sensor pod remains adhered to the 
skin and the sensor probe remains beneath the skin (0.5 inch/1.27 cm) to measure 
glucose levels. The sensor probe is a platinum/silver wire about the width of 2 human 
hairs. 
 
Dexcom additionally providers instructions for cleaning and disinfecting the transmitter 
between users, as the transmitters may be re-used for up 90 days (see ‘Dexcom CGM 
Cleaning (External Studies)’ pdf). 
 
Participants may experience skin irritation or redness around the continuous glucose 
monitor device’s adhesive patch, and there is the potential risk of infection. They will be 
instructed to avoid placing the device near tattoos, scar tissue, and boney areas.   
 
If the participant is conducting the Study Visit in-person, then research staff will apply 
the CGM transmitter and set up the CGM receiver for them. Applying the CGM 
transmitter involves using a device-specific applicator to affix an adhesive casing to the 
back of the upper arm, and then placing the CGM transmitter into this casing so that it 

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remains continuously on the body. If it is a remote visit, a Zoom or telephone meeting 
will be scheduled so that research staff may verbally assist the participant and their 
adult family member/partner who will help them apply the CGM transmitter. For the 
remote visits, participants and the person helping them apply the CGM transmitter will 
be instructed to watch the YouTube video (link above) on application. First, an alcohol 
prep pad will disinfect the upper posterior portion of the participant’s non-dominant arm, 
then research staff or the person helping them at home will apply the adhesive casing 
(i.e., place the applicator on upper arm, and push the orange button) and then insert the 
CGM transmitter into the casing. Next, research staff will either set up the CGM 
receiver, or walk the participant through setting up the receiver by inputting the serial 
numbers included on the CGM transmitter packaging. 
At the end of the CGM assessment, participants, either themselves or with assistance, 
will peel off and remove the casing/CGM transmitter from their arm. The participants will 
also disable the CGM receiver once the transmitter has been removed. Only the CGM 
receiver and charger will be returned to study staff (i.e., the transmitter and its adhesive 
casing may be discarded).  
 
Participants will be instructed to keep their CGM receivers (i.e., a device the size of a 
cell phone that records the glucose measurements obtained from the CGM sensor) 
within 20 feet of themselves as much as possible (e.g., carry it in their purse), to spend 
no more than 2 hours away from their receivers, and to charge its battery every 3 to 5 
days. Participants will also be asked to wear loose fitting clothing for the duration of the 
CGM assessment. Receivers will be in blind mode, thus the only alerts that may trigger 
are the signal loss alarm (e.g., when the sensor/transmitter are greater than 20 feet 
away from then receiver), the sensor fail alarm, and the receiver low battery alarm. No 
alarms related to CGM readings will trigger in the blind mode.  
 
Participants and their providers will be masked to their CGM data (i.e., receivers set in 
blind mode) since there is currently insufficient evidence on CGM targets for women 
with/at risk for GDM and thus no clinical standards to guide the use of CGM for GDM 
management (i.e., recommended percentages of time spent in range, below range and 
above range are currently not available for this population).68 As such, the CGM data 
will not be monitored by study staff and no feedback will be provided to study 
participants based on their CGM data. Participants with GDM will use capillary glucose 
measures as their clinical glucose monitoring metric for the duration of their pregnancy 

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(i.e., the glucose monitor provided by their health insurance) and receive feedback from 
HiROC clinic staff based on those metrics. It is anticipated that the investigatory CGM 
data collected for this study will contribute to increased scientific understanding to 
inform the adoption of CGM in clinical care of women with GDM in the future (i.e., 
thereby reducing the burden of finger sticks for capillary glucose readings).   
 
Participants will return their completed Study Visit 1 materials to study staff by leaving 
them with the HiROC receptionists (e.g., if they have a prenatal care appointment 
already scheduled) or mailing them (i.e., prepaid FedEx mailers with the study’s 
address will be provided) or arranging for study staff to pick them up from their home. 
Participants will schedule a date/time for their Study Visit 2 at conclusion of Study Visit 
1. 
 
Study staff will make photocopies of the capillary blood glucose values recorded for 
HiROC clinical care (i.e., between the first new GDM appointment and the follow-up 
GDM visit one week later, these are recorded in the HiROC purple self-monitoring 
booklet distributed to all new GDM patients) to supplement the Study Visit 1 data, for 
women with GDM only. For all participants, all prepregnancy and pregnancy weights, 
and height, will be abstracted from the medical records, as will the results of all blood 
glucose testing during pregnancy.  
 
Participants will not be randomized until all elements of Study Visit 1 have been 
completed (i.e., surveys and FFQ, PAM, PAM diary log, CGM) and received by study 
staff. These elements must be completed and received by 30 weeks 6 days gestation in 
order to be randomized. 
     
 
M. Randomization 
Participants will be randomized to one of the two interventions upon completion of the 
Study Visit 1 data assessment; they will be contacted by text message and/or ultimately 
by telephone, by their interventionist, to learn the group they are assigned to and 

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schedule the initial intervention session (described below). We plan to recruit and enroll 
up to 48 participants so that we may randomize at least up to 36. Randomization will be 
stratified for at risk for GDM vs. diagnosed with GDM (split evenly between strata). We 
will utilize block randomization (to ensure equal sample sizes), with a block size of 4. 
The allocation sequence will be managed by Dr. Cristina Barroso (UTK, Public Health) 
and concealed from the study intervention staff until it is needed. Intervention staff will 
contact the participants to inform them of their assigned intervention condition and 
schedule the initial intervention session (at < 31 weeks 6 days gestation). 
 
 
N. Study Visit 2 (Follow-up Data Assessment, Study Visit ≤ 36 weeks gestation) 
Staff will remind the participant of the scheduled day/time of her Study Visit 2 either 
during an intervention session or by text message (see Section R for a description of 
the interventions). Study visit 2 may occur remotely, via Zoom, or at UTMC. If it is a 
remote visit, all materials will have been either mailed ahead of time or dropped off at 
the participants’ home. First, the women’s weight will be measured by study staff and 
the ‘in-person’ survey completed (e.g., to collect information on adverse events). If it is a 
remote visit, a scale will be left with at the home with her other study materials, and a 
weight measurement taken during/soon after the Zoom session. Weight will also be 
obtained from the medical record. Second, study staff will review the PAM data 
assessment protocol (e.g., they will be asked to wear the device continuously for 7 days 
on their dominant wrist, but if that is not possible, they are to record the days/times of 
device removal in a diary log) and give the women her PAM and PAM diary log. Third, 
study staff will give the participant a Study Visit 2 at home survey and Food Frequency 
Questionnaire (FFQ) to take home, plus a number 2 pencil for the FFQ. Forth, the 
medical release form for their infants’ data will be reviewed. 
 
In addition, the continuous glucose monitor will be applied to the participant. 
If the participant has GDM, copies of her purple HiROC capillary glucose record sheets 
will be obtained. Participants will return their Study Visit 2 materials to study staff by 
leaving them with the HiROC receptionists (e.g., if they have a prenatal care 

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appointment already scheduled), mailing them (i.e., prepaid FedEx mailers with the 
study’s address will be provided), or arranging for study staff to pick them up (the later 
preferred). 
 
 
O. Newborn Infant Measurements, the Delivery Visit 
On the Study Visit 1 in-person survey, participants will be asked if they are interested in 
participating in the optional delivery visit. If so, they will be asked to provide the names 
and telephone numbers of 1-2 individuals who plan to be with them at the delivery and 
to give study staff permission to contact those individuals to help schedule the newborn 
infant measurements. Participants will be asked to update this information, if it has 
changed, at Study Visit 2 in-person survey. Study staff will check in with those 
individuals by text every few days around the woman’s estimated delivery date/C-
section date to schedule the newborn infant measurements, ideally before she is 
discharged.  
 
Study staff will also distribute delivery visit reminder cards at Study Visits 1 and 2 that 
contain the telephone number to call or text once they go into labor; participants will be 
instructed to keep this reminder card in their hospital bags.   
 
Study staff will also remain in contact with the UTMC staff in labor and delivery so they 
are aware that the patient is a study participant and will need newborn infant 
measurements. Study staff will additionally search the Medical Center’s electronic 
admission system and the labor and delivery patient board for study participants as they 
near delivery. UTMC staff in labor and delivery and the Mother/Baby Units will also help 
facilitate scheduling the delivery visit to obtain the newborn measurements. 
 
Newborn measurements will not be taken if the baby is admitted to Neonatal Intensive 
Care and is critically ill. Measurements will take place only at UTMC or the participants’ 
homes. 
 

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First, study staff will weigh the baby (using a portable study scale). Second, study staff 
will measure the length of the infants (i.e., recumbent length with a portable 
infantometer). Third, study staff will measure the infant’s head, abdominal and arm 
circumferences (i.e., using a tape measure). Forth, study staff will measure flank, thigh, 
triceps, bicep and subscapular skinfolds with calipers to assess body composition. The 
mother can hold the infant during the circumference and skin folds measurements. 
Although there is no risk of harm from these measures, the baby may briefly experience 
a very mild discomfort resulting from the light pinch of skin with the caliper (this pinching 
sensation is about as uncomfortable as if one were to lightly take a pinch of skin 
between the fingers).  
 
Due to COVID-19, the Delivery Visit may potentially be canceled. 
 
 
 
P. Interventions 
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 physical activity tracker to log 
and track their walking/stepping in place, and to get at least 3,000 steps during their 30 
minutes of walking/stepping. The STEP Up intervention will offer a FitBit Charge 3; the 
devices will be managed by Fitabase so that both the participant and the interventionists 
will be able to view her Activity Log (i.e., the Fitbit’s record of minutes spent 
walking/stepping and the number of steps obtained during those minutes), and will thus 
encourage the use of that device. Women randomized to the PA intervention will have 
an initial video chat (i.e., Zoom) counseling session to discuss exercising safely and 
exercising safely during pregnancy, go over the STEP Up program goals, set a 
walking/stepping goal for the following week, and receive and review use of the Fitbit to 
track progress towards their goal. They will then participate in 4 telephone/video chat 
sessions to discuss progress towards their walking/stepping goals and receive behavior 
change counseling to maintain and increase their walking/stepping (i.e., approximately 1 
telephone session per week). They will be offered optional maintenance sessions 

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through delivery, as requested (i.e., approximately weekly). If the participant does not 
have internet access, the intervention will be delivered entirely by telephone. 
 
Women randomized to the ‘Next Steps’ intervention will receive information on mom 
and baby wellness that is unrelated to physical activity, diet, metabolism, or weight (e.g., 
her own immunization status during pregnancy and encouragement to immunize her 
baby on schedule, infant car seats & safety checks, contraceptive options and a 
contraceptive plan), delivered in 5 telephone/video chat sessions (identical to the STEP 
Up intervention described above) in order to control for contact time.   As such, the trial 
is called Project Wellness and it will be advertised that all study participants will work 
with a lifestyle coach on wellness.  
 
For both interventions, study staff will schedule the initial intervention session by 
phone/email/text message. The first session will be by video chat (i.e., Zoom), if 
possible, and occur at ≤ 31 weeks 6 days gestation; and the remaining 4 
telephone/video chat sessions are to be completed by ≤ 36 weeks 6 days gestation. 
The first session will last approximately 30-40 minutes. The remaining sessions will be 
approximately 10-20 minutes in length. Participants in the PA intervention will be given 
the option to continue their weekly sessions beyond 36 weeks of gestation (i.e., 
maintenance phase of the intervention, receiving approximately 1 telephone session per 
week). A subset of intervention sessions will be audio recorded to assess fidelity.  
 
For both interventions, participants will receive an intervention workbook (i.e., specific to 
Next Steps and STEP up programs), with information organized by session. Intervention 
staff will offer to send pdfs of the individual sessions’ materials via email to those who 
prefer it.  
 
Given the participants’ busy lives, missed intervention sessions are inevitable. For both 
interventions, after 2 unsuccessful contact attempts to reschedule an intervention 
session (i.e., participant doesn’t call back or send an email/text message with a time to 
reschedule the session), intervention staff will contact the alternate contact(s) (i.e., 

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husband, family member) the participant provided on her baseline Project Wellness 
survey. Staff will inform the contact person that the participant missed a scheduled 
phone call/visit and to request she call the staff member back (or send a text) to 
reschedule the call. These individuals will be contacted only once. After two consecutive 
weeks of unsuccessful attempts to contact (i.e., with no response by telephone, email or 
text messaging from the participant or the alternative contact), the participant will be 
considered a passive drop and will be sent a “passive drop” email (stating she will be 
dropped from the STEP Up/Next Steps program if she doesn’t reply in 2 days) as a final 
attempt to reengage her in the intervention.  

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