My Baby My Move A Community Wellness Intervention
Phase: NA
Conditions: Gestational Weight Gain
Sponsor: University of Colorado, Denver

 
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w 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #:  19-1366 
Project Title: My Baby My Move+ 
Principal Investigator:  Jenn Leiferman 
Version Date: 5.6.21  
 
  
 
I. Hypotheses and Specific Aims:    
Statement of Purpose: The proposed study will implement and test the feasibility of a 
theoretically-based (e.g., social cognitive theory), peer-led wellness intervention, “My 
Baby My Move+” (MBMM+) to reduce excessive gestational weight gain (EWGW) by 
targeting physical activity, mood, and sleep.  
The aims of the proposed research are to: 
● 
Aim 1. Determine feasibility (i.e., acceptability and demand) of the MBMM+ 
program. 
● 
Aim 2. Examine the impact of the MBMM+ program on EGWG at 12 weeks post-
baseline to determine estimates of effect size for a future, larger randomized trial. 
 
II. Background and Significance:  
 Up to 50% of pregnant women in the U.S. gain weight in excess of the Institute of 
Medicine (IOM) guidelines (i.e., excessive gestational weight gain (EGWG)). EGWG 
leads to poor maternal (e.g., pre-eclampsia, gestational diabetes, postpartum weight 
retention) and child (e.g., preterm birth, large for gestational age weight at birth) outcomes. 
It also sets the stage for long-term overweight/obesity for both mother and child. There are 
few efficacious intervention strategies for reducing EGWG and among those, physical 
activity is one promising strategy. Prenatal physical activity is associated with a variety of 
health benefits (e.g., reducing risks for gestational diabetes, pre-eclampsia, depression, and 
body image dysphoria). There is also a need to increase prenatal physical activity as 
approximately 80% of pregnant women are not meeting recommended levels. One reason 
for low prenatal activity is that pregnant women are concerned with and lack 
knowledge/skills about how to safely and effectively participate in physical activity. 
Increasing knowledge and skills about physical activity may improve prenatal physical 
activity participation, lower safety concerns, and in turn, reduce EGWG. 
To increase the likelihood one will consistently engage in regular prenatal physical 
activity, knowledge and skill building need to be coupled with strong motivation. Our pilot 
work suggests that focusing on the interrelationship among physical activity, mood, and 
sleep is of particular importance to instilling motivation for prenatal activity. Many women 
struggle with poor mood during pregnancy with prevalence rates ranging from 12%-51%. 
Pregnant women also suffer from poor sleep quality, which is associated with negative 
mood during pregnancy. In a vicious circle, poor sleep quality and depressed mood can 
hinder the very physical activity patterns that have been shown to significantly reduce 

 
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depressive symptomatology and improve sleep quality during pregnancy. Moreover, poor 
sleep and mood are also related to EGWG. Women who understand through self-regulation 
how physical activity benefits their mood and sleep may be more motivated to continue 
with activity. Thus, physical activity interventions may be more effective if they 
simultaneously target mood and sleep. Given this, there is a significant need to develop 
sustainable and scalable interventions that emphasize the importance of both understanding 
the benefits of physical activity, mood and sleep during pregnancy and developing 
strategies to support and motivate safe and effective engagement in prenatal physical 
activity to ultimately reduce EGWG. To our knowledge there are no published intervention 
studies examining this triad to reduce EGWG. Moreover, there are limited efficacious 
prenatal physical activity interventions currently available. A recent review of the literature 
related to physical activity and pregnancy highlights that little is known about the efficacy 
for physical activity interventions during pregnancy. Only three of the nine studies 
reviewed showed significant effects on physical activity and most studies had major 
limitations including: 1) use of self-report to measure physical activity as compared to 
objective physical activity measures; 2) high attrition rates, 3) underpowered, 4) devoid of 
a theoretical framework; and 5) none focused on the triad of physical activity, mood, and 
sleep. Thus, there is a clear need for developing effective, theoretically-based prenatal 
physical activity interventions that target these modifiable outcomes. 
There are numerous established benefits of prenatal physical activity including reduced 
EGWG [6] [7]. However, many pregnant women do not engage in the recommended 
amount of physical activity with less than 20% of women in the US (as well as in CO) 
reporting regular physical activity [8, 9]. Given the benefits of prenatal physical activity 
and the short/long-term risk reduction in EGWG and obesity, respectively, it is evident that 
pregnancy is a critical time in a woman’s life to adopt a physically active lifestyle. A 
recent review suggests there is a need for theoretically-based, well-designed prenatal 
physical activity interventions [10]. The proposed study 
addresses this need and underscores scientific rigor by utilizing a strong study design and 
theoretical framework based on the Social Cognitive Theory coupled with evidence-based 
strategies based in part from formative work to increase prenatal physical activity [11]. 
Pregnant women are at elevated risk for poor mood (i.e., depressive symptomatology) and 
sleep quality [12] [13]. Regular physical activity engagement reduces depressive 
symptoms as well as enhances sleep quality [14] [15]. In particular both walking and 
mindfulness yoga have been shown to decrease depressive symptomatology [14] [16]. 
Further, we posit that once women begin to engage in regular prenatal physical activity 
they will notice these improvements in sleep and mood via self-regulation (i.e., tracking of 
physical activity, sleep, and mood) which in turn, will further motivate them to continue to 
engage in physical activity. If found true, future interventions 
targeting this triad (i.e., physical activity, mood and sleep) may significantly improve the 
likelihood that women will sustain regular prenatal physical activity and thus, reduce or 
prevent EGWG. Moreover, enhancing sleep and mood may also directly reduce EGWG 
[17] [18]. Need for Peer Mentor Delivery Systems. Extant EGWG interventions mostly 
focus on testing clinical interventions in healthcare settings and lack integration into 
communities. Peer-mentors as delivery agents may be an effective strategy to translate 
prenatal physical activity programs such as the MBMM+ program into the community [19-

 
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23]. Studies suggest peer delivered interventions (i.e., trained volunteer peers) may be as 
effective as professional staff delivered interventions in 
helping individuals improve and maintain physical activity [21, 22]. Pregnant women 
specifically have reported valuing interpersonal interactions to motivate and support 
behavior change such as physical activity with other pregnant women (i.e., peers they can 
identify with) [21, 23, 24]. Additionally, utilizing peer mentors may mitigate reliance upon 
professional staff and provide a low cost opportunity for dissemination [21, 22] of 
evidence-based practices improving likelihood of future scalability. The proposed study 
plans to test the feasibility of a peer-delivered, theoretically-based intervention (i.e. 
MBMM+). 
The proposed study aims to reduce EGWG by uniquely targeting the triad: prenatal 
physical activity, mood, and sleep quality. There are no known EGWG interventions using 
this approach. One of the foci of this proposal is the potential sustainability of MBMM+. 
Few EGWG interventions have focused on the potential sustainability of peer-led, 
community-based programs and therefore despite being effective, dissipate over time. We 
propose to develop and test a potentially feasible as well as sustainable EGWG 
intervention to instill good healthy habits (e.g., prenatal physical activity, good sleep 
hygiene, stress management) during and beyond pregnancy. 
 
III. Preliminary Studies/Progress Report:   
This proposal extends a pilot program called My Baby, My Move (MBMM; PI: Leiferman 
J), funded by the Centers for Disease Control and Prevention aimed at developing and 
implementing a prenatal physical activity intervention to promote regular engagement in 
moderate-intensity physical activity. The development of the MBMM intervention 
stemmed from conducting individual and focus group interviews with over 65 pregnant 
women to better understand what facilitates and prevents engagement in prenatal physical 
activity [24]. The 8-week MBMM intervention was beta-tested on 66 pregnant women 
(n=33 MBMM intervention; n=33 educational control group) during mid-late second 
trimester throughout third trimester. Total physical activity (light, moderate, vigorous) 
increased in the intervention group by over 80 minutes from baseline to 3 months 
postpartum [294 min/wk (SD 89.8) to 373.1 min/wk (SD 146)] whereas the control group 
decreased over time [309 min/wk (SD 146.6) to 302 (SD 112.1)]. The intervention was 
also successful in increasing certain known mediators of physical activity, such as 
behavioral skills (e.g., self-regulation) [pre: mean 32.75(SD 8.8)//post: mean 39.33(SD 
5.30) (p=0.03)] and social support [pre: mean 26.17 (SD 8.94)//post: mean 33.75 (SD 
10.01) (p=0.02)]. The process evaluation for the MBMM program found high fidelity in 
intervention delivery, average attendance (88% for each session over an 8 week period) 
and high satisfaction with the program (1.3 on a 5 point scale, with 1 being extremely 
satisfied). A major limitation to these data is that we did not collect data on EGWG. 
Additionally physical activity data were self-report and standard of care was used as a 
comparison group. Although these data are encouraging and in the hypothesized direction, 
based on feedback from participant post-intervention qualitative interviews (unpublished) 
and current recommended evidence-based strategies, we are proposing to test an enhanced 
version of MBMM called MBMM+ that will 1) examine the impact of the intervention on 
EGWG, 2) add in-depth information on new topics related to mood (stress-management, 

 
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mindfulness, wellness wheel, family/life balance) and sleep (good sleep hygiene, 
sleep/energy balance) given their inter-relatedness to EGWG and physical activity, 3) add 
a comprehensive objective assessment of physical activity, 4) add an appropriate 
comparison group that controls for time and attention (i.e. health education group); 5) add 
yoga as a programmatic activity component throughout program, and 6) increase 
participant/peer leader contact time by addition of more small group participant 
interactions with peer leaders. To do so, we will increase the length of intervention from 
eight to 12 wks as well as the dose from one session/wk to two sessions/wk. 
 
IV. Research Methods 
A. 
Outcome Measure(s):  The Assessment Table (Table 1) displays all primary and 
secondary outcomes, associated measures, and the timeline of data collection. Data will be 
collected at four timepoints: T1) baseline, T2) 6-weeks post-baseline, and T3) 12- week 
post-baseline (i.e. end of intervention) and T4) at time of delivery. 
 
Assessment tools (scale and Fitbit) will be delivered to participants after eligibility is 
confirmed and after they complete the online consent and baseline survey at a time and 
location of their choosing. A scale and Fitbit with a brief one-page protocol will be 
delivered to the participants by the Study Coordinator.  Seven-days after delivery, the 
Study Coordinator will pick up the Fitbit (from all participants) and scale (from control 
participants). The participants will leave these materials at a specific location for the Study 
Coordinator. There will be no contact between them. During this time, the Study 
Coordinator will either drop off a hard copy of the curriculum (or send an electronic 
copy)as well as incentives for the intervention group participants (yoga mat and 
pedometer). The team has instituted strict protocols to minimize exposure related to 
COVID-19. This includes: 
● 
No contact with participants; the Study Coordinator will leave the materials 
mentioned above at a specific location dictated by the participant (e.g. front porch).  
● 
The Study Coordinator will wear a mask at all times when doing deliveries of 
assessment and programmatic materials. 
● 
The Study Coordinator will complete a symptoms checklist and take their 
temperature prior to dropping off assessment and programmatic materials. This will be 
shared with the PI prior to delivery. 
● 
The Study Coordinator will keep hand sanitizer in their car and use before and after 
delivery of assessment and programmatic materials. 
● 
The research team will follow all safety protocols instituted by the University of 
Colorado regarding COVID-19 and human subjects research.  
 
Weight Gain. Weight will be collected at T1 and T3 for all intervention and control 
participants. Participants will be asked to record their weight three times on one day and 
send a picture (via text or email) to a member of the research team during the 7-day 
assessment week. Individuals will be asked to remove their clothes and shoes and keep on 
their undergarments and weigh themselves first thing in the morning before they eat 
anything. Total GWG will be captured three times consecutively and then averaged across 
these three weight recordings. Total GWG will be compared to the IOM guidelines at T1 

 
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and T3 and calculated as: +, -, or 0 with respect to the guidelines (based on each woman’s 
pre-pregnancy BMI-determined GWG category) such as GWG above the guidelines (+), 
below guidelines (-), or within the guidelines (0) [39]. Participants randomized to the 
intervention group will also be given a TANITA scale to measure weight at home daily 
(the research team will send weekly reminders via email or text). Women will step on the 
scale and note their weight on a tracking log at the same time each day. Participants will 
email copies of tracking logs weekly to the study coordinator. Please see appendix for 
tracking log.  
 
Physical activity. All participants (intervention and control) will wear a Fitbit Charge 3,  
which is a wrist worn physical activity tracker, for a 7-day period during T1 and T3. Fitbit 
counts the minutes of activity/steps each day. The use of Fitbit devices have been validated 
in pregnant women (St-Laurent, Mony, Mathieu, & Ruchat, 2018). Activity will also be 
formally assessed with all participants using an adapted version of the Leisure-Time 
Exercise Questionnaire (LTEQ; Godin & Shepherd, 1985) at three time points (T1, T2, and 
T3). Additionally, participants will be assessed using the short form of the International 
Physical Activity Questionnaire (IPAQ; Hallal, 2004). Participants will complete the 
consent and survey electronically prior to the Fitbit and Scale delivery.  Women will be 
asked to report how many days per week and minutes per day they engaged in regular 
exercise behavior. Reported minutes per day will be multiplied by days per week to 
calculate minutes per week of regular exercise behavior. The LTEQ is a valid and reliable 
measure of leisure-time exercise behavior (Godin & Shepherd, 1985) and has been used 
with pregnant women to better understand their exercise behavior (Sattler et al., 2018). 
Although, primary outcome physical activity data will be assessed by the Fitbit, LTEQ 
data will help further describe modes and intensities of physical activities. Women 
randomized to the intervention arm of the study will also informally track their daily 
physical activity on a tracking log. Participants will email copies of tracking logs weekly to 
the study coordinator.  
Mental Health will be formally assessed at T1, T2 and T3 by using four mood measures 
including: 1) Edinburgh Postnatal Depression Scale (EPDS), 2) General Anxiety Disorder- 
7 scale (GAD-7), 3) Perceived Stress Scale (PSS), and 4) Mindfulness Attention 
Awareness Scale- 5 (MAAS-5). Participants will complete the consent and survey 
electronically prior to the Fitbit and Scale delivery. The EPDS is a self-report 10-item tool 
that has been used extensively in the past to assist in the identification of women who may 
be suffering from depression (during pregnancy and postpartum). Each of the ten questions 
has four possible responses (ranging from 0 – 3) with a total score range of 0-30 and 
demonstrates high internal consistency [45].  The GAD-7 is a brief measure of anxiety. For 
a cutoff score of >=10, the GAD-7 has a sensitivity of 89% for Generalized Anxiety 
Disorder and a specificity of 82%. Perceived stress will be measured using the The Cohen 
Perceived stress scale which is a validated tool and is designed to measure “the degree to 
which situations in one's life are appraised as stressful”. (Cohen, Kamarck, & Mermelstein, 
1983). The PSS consists of 10 questions measured with a 5-item likert scale. Finally, the 
MAAS includes 5-items related to mindfulness and shows high internal validity (4). 
Women randomized to the intervention arm of the study will also informally track their 

 
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daily mood activity on a tracking log. Participants will email copies of tracking logs 
weekly to the study coordinator.  
Sleep Quality. Sleep will be assessed in all participants at T1, T2 and T3. The Pittsburgh 
Sleep Quality Index (PSQI) is a 19-item self-rated questionnaire which assesses subjective 
sleep quality, latency, duration, and disturbances over a 1-month time interval. It also 
measures sleep medication usage and daytime dysfunction over the past month. Total PSQI 
has demonstrated construct validity and internal consistency in pregnancy [46].  
Participants will complete the consent and survey electronically prior to the Fitbit and 
Scale delivery. Sleep data will also be collected from the Fitbit device during T1 and T3. 
Fitbit sleep data includes total minutes of sleep, as well as total minutes in REM sleep, 
light sleep, and deep sleep. Women randomized to the intervention arm of the study will 
also informally track their daily sleep activity on a tracking log. Participants will email 
copies of tracking logs weekly to the study coordinator. 
Nutrition. Nutrition-related behaviors will be formally assessed in all participants at T1 and 
T3. The Three Factor Eating Questionnaire is a 51-item questionnaire developed by 
Stunkard and Messick (1985) to measure three dimensions of human eating behavior: 1) 
dietary restraint, or cognitive control of eating behavior, 2) dietary disinhibition, or 
disinhibition of cognitive control of eating, and 3) susceptibility to hunger.  We will only 
use 18 items of the revised TFEQ from Cappelleri (2009). Participants will complete the 
consent and survey electronically prior to the Fitbit and Scale delivery.   
 
Theoretical Mediators. 
1) A modified version of the Exercise Self-Efficacy scale [47] will be used to assess 
participants’ beliefs in their ability to participate in physical activity. Internal consistencies 
are good (Cronbach’s α = .99 across time points). All participants will complete this tool at 
T1 and T3. 2) Behavioral Skills (e.g. self-regulation) will be assessed using three tools: 1) 
a 15-item subscale used in Project Grad [48], 2) the Pregnancy Weight Gain and Attitude 
Scale (PWGAS) (Downs, 2003, 2004), and 3) a 3-item scale to assess perceived behavioral 
control (Downs, 2003, 2004). All participants will complete these tools at T1 and T3 3) 
Social support for physical activity will be measured using two tools: 1) Social Support 
and Physical activity Scale [49] which assesses perceived social support from both family 
and friends on a 13-item scale, and 2) the General Social Support Questionnaire (SSW) 
which measures social support and satisfaction with social support. The SSQ has good test-
retest reliability and convergent internal construct validity. All participants will complete 
these tools at T1 and T3.  
Delivery outcomes (i.e., delivery type (vaginal vs. caesarian section), birth weight and 
gestational age, intervention used (if any), and maternal weight at delivery) will be 
assessed via self-report survey through REDCap.  
 
Demographics 
Socio-demographics (e.g., race/ethnicity, marital status, age, parity, income, education, 
insurance coverage) will be assessed via baseline survey at T1.  
 
Optional data collection procedures 
Participants may be contacted at the conclusion of the study and given the opportunity to 
choose to participate in a phone or zoom interview to better understand their thoughts about 

 
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participation in the program (to what extent they were satisfied with the program and parts 
of the program they enjoyed and parts they think could be stronger, etc). The interviews will 
be approximately 45 minutes long and you will be compensated $30. Up to 15 women will 
be invited to participate in an interview. Due to COVID-19, the trial will be run two times; 
a remote pilot of the trial will be run in the Fall of 2020 (n=30), followed by a larger in-
person trial (pending COVID-19) in the Spring of 2021 (n=70)  
Interviews with participants will be conducted after the pilot trial (Fall 2020) in addition to 
after the full trial (Spring 2020). 
B. 
Description of Population to be Enrolled:   
We anticipate eligibility screening for pregnant women (6 through 12 weeks) to take 
approximately 5-10 minutes to complete. The time window for gestational age recruitment 
was selected based on our formative work [25] [26] that suggests that in order to impact 
EGWG early intervention is critical. The first 4 weeks of the intervention will consist of 
educational materials as women may not want to participate in physical activity until near 
the end of first trimester when their risk for miscarriage drops and the mother tends to feel 
better physically. The experiential component (i.e., walking and yoga) will start in week 5. 
In order to extend our recruitment window, we will create rolling recruitment opportunities 
with women entering into the program from weeks 1 through weeks 6 (weeks 1-4 electronic 
materials; weeks 5-6 zoom sessions begin).  All women will receive the electronic materials 
for weeks 1-4 before starting the zoom group sessions in week 5.  For those women who 
start the zoom sessions in week 6, they will receive an additional session (material from 
original week 5) at the end to ensure all women receive 16 sessions (8 weeks of zoom 
sessions).   Women will be recruited from the University of Colorado Clinics, clinics in 
Denver Metro and surrounding areas as well as social media (e.g. facebook and 
instagram).   We will work with providers to help with recruitment of women in need of 
intervention for EGWG. 
 
Sample Size. In terms of intervention effects on EGWG, results have been variable across 
studies, with average intervention effects being small to moderate. In terms of physical 
activity, our preliminary work with the original MBMM showed an effect roughly equivalent 
to Cohen’s d = 0.69. This effect falls into the moderate range, similar to higher-impact 
interventions on EGWG [27]. Based on these two effect ranges, we estimated effect size to 
detect effects of d > .63, a medium effect, for the proposed MBMM+ intervention. Using 
this effect size, α = .05, and 1-β = .80, a sample size of 40 per arm (80 total) would be 
adequate to detect medium effects in EGWG, exercise, and other outcomes. We propose 
enrolling 50 per arm to account for up to 20% attrition and to allow for power to detect 
potentially smaller effects for EGWG. This level of power is expected to also be adequate 
for detecting changes in mediators, which have previously been observed to be more 
powerfully affected by the MBMM intervention than physical activity. 
 
Due to COVID-19, the trial will be run two times; a remote pilot of the trial will be run in 
the Fall of 2020 (n=30), followed by a larger in-person trial (pending COVID-19) in the 
Spring of 2021 (n=70)  
 
C. 
Study Design and Research Methods   

 
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Intervention Group: 
The MBMM+ intervention is designed to promote the engagement in physical activity and 
takes into account barriers among pregnant women cited in our formative work such as 
lack of knowledge and skills, body changes and discomfort, feeling limited, and lack of 
social support [24]. Uniquely, the MBMM+ program also targets sleep hygiene and mood 
to further support regular physical activity engagement. Over the years of working with 
pregnant women, we have observed that once women notice how their regular physical 
activity helps their mood and sleep patterns they are often more likely to continue 
engaging in regular physical activity. During the first four weeks of the MBMM+ program, 
participants will receive electronic informational handouts covering topics on weight 
management (content will be based in part on Co-I Downs’ Healthy Mom Zone 
intervention such as informing on benefits and guidelines of healthy GWG, tips on healthy 
eating, energy balance, and sleep quality) [26] as well as the benefits and safety concerns 
related to prenatal physical activity. Starting week 5 of the 12-week intervention, 
participants will attend two virtual, group sessions per week with each session lasting 
approximately 30 minutes and will be held remotely via zoom. Sessions will be held on 
weekday evenings and weekend mornings as these times were preferred by pregnant 
women. Given that pregnant women often express a lack of knowledge about safe physical 
activities during pregnancy, preventing them from engaging in physical activity, each 
session will include both didactic and experiential components to increase knowledge and 
skill building. Sessions will begin with a didactic component covering overcoming barriers 
to physical activity, goal setting, self-monitoring, problem solving, topics related to mood 
(stress management, family/work balance, wellness wheel), sleep hygiene (setting routines, 
avoiding stimulants, environmental supports), and additional physical activity topics (e.g., 
managing physical activity in postpartum, overcoming relapses). Participants will be given 
educational materials in print and electronic form based on their preferences. Participants 
will then be encouraged to complete the experiential component (i.e., physical activity) on 
their own for 30 minutes in duration and involve primarily walking, at a moderate 
intensity, based on national recommendations [28] coupled with yoga. Yoga classes will be 
led remotely four times throughout the program. For these sessions, the online class will 
last 60 minutes; 15 minutes of didactic followed by 45 minutes of yoga. Our formative 
work suggests that mothers prefer walking and find it more enjoyable in the form of 
groups. We have chosen to also include yoga to provide options for ways to be active that 
also positively impact sleep and mood [16] [29] and pregnant women report desiring 
prenatal yoga [30]. All didactic sessions will be facilitated by the peer leaders (see below). 
The yoga sessions will be taught by an experienced prenatal yoga instructor residing in 
Denver, CO.  
 
For the remote pilot trial in the Fall of 2021, each session will have one lead Peer Leader 
and one additional peer leader to help facilitate the sessions and support goal setting. Our 
MBMM formative work and expertise in community-based physical activity interventions 
suggests participants prefer peer group leaders because they foster a sense of community 
and social support within the group setting [23]. Peer leaders will be compensated for their 
time working with the MBMM+ program and will be peer mothers from the community 
who are recent mothers (< two years postpartum) who successfully engaged in regular 

 
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physical activity during a previous pregnancy. Peer leaders will be identified by our 
research team, recreation center directors, and health care provider partners. At the end of 
every didactic session, participants will check in with an assigned peer leader to discuss in 
small groups their weekly logs. The team will use the ‘breakout room’ feature in zoom to 
divide the larger group into their smaller groups for these discussions. Peer leaders will 
note the discussions that occurred amongst the participants in their group, describe barriers 
that were identified, problem-solving strategies that were suggested and used, and future 
goals/recommended action steps. This group work will help participants to learn ways to 
fit physical activity into their lifestyle and overcome barriers by receiving feedback from 
their peer leader and other group members. It will also ensure that the intervention is 
conducted and received in the way intended as the peer leaders and program manager/PI 
will review these small group progress notes each week and monitor intervention delivery.  
 
Peer leader training and fidelity: Weekly, the research team will have phone calls with the 
group peer leaders to debrief and address any issues that may arise. At least one member of 
the research team will participate in all sessions to ensure quality control of intervention 
delivery and data collection efforts by peer leaders. The PI will conduct a training session 
delivered remotely before the onset of the intervention with the peer group leaders to cover 
topics including how to engage in safe and effective physical activity during pregnancy, an 
overview of behavioral change theory and the behavioral skills that the intervention is 
targeting, ways to garner social support and leadership skills. The PI has been extensively 
trained by the Cooper Institute in Prenatal-Postnatal Physical Activity. The yoga instructor 
will have been extensively trained in prenatal yoga. 
 
Control Group: 
Women randomized to the control group will complete a similarly structured 12-week 
program; electronic materials related to various prenatal topics including preparation for 
birth, birthing options, and responsive parenting will be distributed twice a week for the 
first 4-weeks of the program. Starting week 5 of the 12-week intervention, participants will 
attend two virtual, group sessions per week with each session lasting approximately 45 
minutes. Sessions will be held remotely via zoom. Sessions will be held on weekday 
evenings and weekend mornings as these times were preferred by pregnant women. 
 
The Intervention-group Table of Contents and Control-group Table of Contents displays 
all key topics presented throughout the 12-week intervention and control groups.  Please 
find study materials for intervention and control arms in the Appendix. 
 
D.   Description, Risks and Justification of Procedures and Data Collection Tools 
 
Recruitment and Informed Consent. Participants for this study will be recruited from 
obstetric clinics located in the Aurora and Denver Metro and surrounding areas, as well as 
facebook and instagram.  The investigators and study staff have completed NIH-approved 
training for human subject-based research, and are experienced at consenting subjects 
according to federal guidelines. Up to 100 pregnant participants will be recruited to 

 
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complete this study (two trials; remote pilot in the Fall of 2020 with 30 participants 
followed by larger trial in the Spring of 2021 with 70 participants).  
 
Recruitment and Informed Consent. The proposed study will utilize recruitment strategies 
that were found to be effective during formative work and are described in the research 
plan. Participants will be recruited actively via clinicians at obstetric clinics.  An 
informational flyer will be shared with all potentially eligible women and women will 
sign-up during check-out if they are interested in the program. Program staff will contact 
interested women and ask pre-screening questions to assess eligibility. Participants will 
also be recruited passively via informational flyers; these flyers will contain research team 
contact information and will be displayed in public spaces at clinics and in community 
settings and on listservs/internet sites. Potential participants can email or call a member of 
the research team to learn more about the study and participate. We are confident that we 
will be able to recruit the necessary sample to conduct the proposed work based on our 
working relationship with local clinics. All eligible participants will need to sign a HIPPA 
waiver with the doctor to enable medical information to be released to the study team as 
well as a waiver stating that they are cleared for physical activity. All eligible participants 
will be asked to complete a consent form and baseline survey (comprised of all T1 tools 
mentioned above) remotely. Once this is completed, participants will receive a Fitbit and a 
scale and complete the 7-day Fitbit assessment period. They will take their weight (three 
times) one day during this period and send an email or text to the Study Coordinator. The 
consent form describes the purpose of the study, criteria for participation, confidentiality 
measures, incentive details, and contact information for the principal investigator. Contact 
information will be stored separately from the surveys such that it could not be linked to 
survey responses.  Upon completion of the baseline survey (T1) and the 7-day Fitbit 
assessment period, participants will be randomly assigned to either the intervention 
(MBMM+ program) or control arm (i.e. health education program) using computer 
generated numbers and assigned from a pre-generated table.  
 
Inclusion criteria – The population of interest includes English-speaking, pregnant (<13 
weeks gestation; or  13-16 weeks gestation and has gained less than 10 lbs in total for 
women of normal pre-pregnancy weight or less than 5 lbs for overweight/obese) 
primiparous women, aged 18-46 years, reside in Denver, CO and have medical clearance 
to exercise during pregnancy.  Exclusion criteria include multiparous and having 
conditions that preclude them from exercising (i.e. HCP has restricted patient from 
engaging in exercise according to AGOG’s absolute contraindications to exercise (e.g. 
haemodynamically significant heart disease, restrictive lung disease,  incompetent 
cervix/cerclage, persistent second or third trimester bleeding, placenta previa after 26 
weeks gestation, premature labor during the current pregnancy, ruptured membranes, and 
pregnancy induced hypertension).  
 
Protection Against Risk. Every effort will be made to ensure the protection of participants 
against risk. First, participation is voluntary and participants may refuse to participate or 
withdraw from the study at any time. Second, participants do not waive any legal rights by 
consenting to the study. Third, the Principal Investigator and program manager will be 

 
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available to participants throughout the study to answer any questions or concerns they 
may have. All information collected from participants will be kept strictly confidential in 
accordance with the study protocol and protected within the limits of the law. Any 
identifying data will be destroyed at the end of the study.  De-identified information 
learned from the study could be used in reports, presentations, and publications but no 
participant will be personally identified.  Risks pertain to psychological discomfort related 
to completing questionnaires on mood.  Additional risk pertains to discomforts pregnant 
women may experience while engaging in physical activity during the intervention and 
control arms of the study such as mild muscle soreness with a small possible risk of injury 
to muscles, ligaments, and tendons of the body.  To minimize these risks, the study staff 
has extensive expertise in designing physical activity programs for pregnant women and 
will closely monitor all activity sessions to reduce this risk.  Also, study staff who will be 
working with the participants in the intervention will be knowledgeable about basic First 
Aid.  A Data Safety Monitoring Plan (DSMP) will also be in place to ensure the safety of 
all participants.  The DSMP will include a Data Safety Monitoring Board (DSMB) and 
comprise the following specialties: obstetrics, exercise physiology, psychology and 
biostatistics and will meet periodically to review any adverse events, data, and procedures.  
Please see DSMP for details. 
In order to minimize psychological risk of harm, we will include detailed information 
about possible risks in the informed consent form and process, which illustrates the most 
sensitive types of questions about which subjects will be asked.  Participants will also be 
instructed that they are free to not answer any questions they do not wish to answer on the 
questionnaires. All participants will also receive information on local mental health 
resources upon completion of each assessment. This resource sheet has types of clinical 
care offered on sliding fee basis as well as free access to various hotlines and community 
resources. 
 
Participants who experience miscarriage will be withdrawn from the study. During the 
study, results on clinical measures may be shared with health care providers to ensure 
participant safety.  This will be explained in the informed consent form.  Finally, with 
respect to potential physical risks to an embryo or fetus, all participants will be informed 
that “This study may include risks to an embryo or fetus that are currently unforeseeable.” 
The Data Safety Monitoring Board will monitor delivery and birth outcome data.  Please 
see below for more information on the DSMP. 
 
If it is discovered that a participant is engaging in behavior which endangers her infant in 
any way, or if there is evidence that any participant is a victim of domestic violence, this 
will be brought to the attention of her healthcare provider who may need to contact legal 
authorities.  Any suspicion of child abuse arising from information collected in this study 
will result in study staff immediately notifying authorities.  
 
Potential Benefits 
Pregnant women in the MBMM+ intervention may have improved health from increased 
levels of physical activity, improved mood and sleep hygiene and weight management. 
 

 
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Participants in the control arm (health education group) may experience enhanced 
knowledge related to pregnancy and child health topics. 
 
Importance of Knowledge to be Gained 
The MBMM+ program is designed to enhance participants’ knowledge, confidence, and 
support to increase their likelihood of engaging in regular physical activity to ultimately 
reduce the likelihood of excessive gestation weight gain. Given the beneficial effects of 
physical activity on many maternal and child outcomes, there is a definite need to promote 
engagement in regular prenatal physical activity.  Moreover, given the detrimental effect of 
excessive gestational weight gain (EGWG) there is a critical need to develop and test 
interventions aimed at reducing EGWG. 
 
E. 
Potential Scientific Problems:  
Throughout the course of this study, we will provide for protection of human subjects.  All 
protocols will be submitted for review and approval to the Colorado Multiple Institution 
Review Board (COMIRB).  All personal data will be kept secure with personal identifiers 
and study identification numbers maintained in separate, secure, databases.  Only the PI 
and Co-Is will have access.  The proposed study is designed to women and overall, the 
findings of this study may potentially impact the health and wellbeing of women and 
children. 
 
We have also designed the assessment procedures to minimize burden on participants. . 
Participants will be compensated $30 per survey completion (T1and T3; $60 
total/participant).  Participants will also receive tickets for a random drawing and chance to 
receive free diapers for their participation in T2 data collection.  Pregnant participants in 
the MBMM+ intervention group will also receive a yoga mat and pedometer, and both 
control and intervention groups will receive drawings for free diapers.  These types of 
incentives and amounts are consistent with our other studies at UCH. In addition to the 
yoga mat and pedometer, the intervention group participants will have the opportunity to 
keep a Fitbit. If participants attend all sessions 8-16, they will get to keep a Fitbit at the end 
of the program following post-data collection. If participants in the intervention program 
attend all but two sessions from sessions 8-16, they will be entered into a raffle for a Fitbit 
to keep at the end of the program following post-data collection.  
 
 
F.   Data Analysis Plan:   
 
We will use latent growth curve models to separately examine intervention effects on 1) 
moderate-intensity exercise assessed by the Fitbit and 2) EGWG. These models will then 
be expanded to examine secondary outcomes (e.g., physical activity, mood, sleep quality, 
delivery outcomes) and mediators (e.g., exercise self-efficacy, social support, and 
behavioral skills). For all models, we will control for patient age, ethnicity, parity, risk 
status, and SES. Primary analyses will be conducted as intent-to-treat, although 
exploratory as-treated analyses may also be used. Analyses will be conducted primarily 
using SAS Version 9.2 and Mplus Version 6.0. In closing, the study’s proposed approach 

 
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is scientifically sound using a tight, randomized controlled trial framework to reduce study 
bias and increase likelihood of reproducibility. 
 
G.  Summarize Knowledge to be Gained:   
This is an important and fundamental study that needs to be conducted to meet the need for 
effective, sustainable community-based interventions to reduce EGWG. Because 
pregnancy is an opportune time to adopt healthy behaviors such as physical activity, there 
is a definite need for intervention at this time. The MBMM+ intervention has been 
designed based on feedback from pregnant women from recent formative and pilot work to 
develop an intervention that is attractive and unique to this population. The intervention 
includes a strong social support component as our formative work and extant literature 
clearly demonstrate lower levels of attrition in interventions providing social support. 
Moreover, the addition of the small group interaction after each session will provide 
further opportunity to build rapport and strengthen interpersonal support and a sense of 
group membership. Third, self-regulation techniques that support maintenance of physical 
activity and its interrelatedness of mood and sleep will be used. All of these supports can 
show successful community-based interventions to reduce EGWG.