Family Diabetes Prevention Program Pilot Study
Phase: NA
Conditions: PreDiabetes, Overweight and Obesity, Type 2 Diabetes, Overweight, Childhood, Obesity, Childhood, Lifestyle, Healthy
Sponsor: Johns Hopkins University

 
 
 
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Family Diabetes Prevention Program Pilot Study 
 
NCT05358444 
 
(Updated 9/23/22) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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1. 
Abstract 
 
There is a rising burden of type 2 diabetes and associated risk factors among children, 
disproportionately affecting low-income and minority communities. Addressing lifestyle-associated risk 
factors is an integral component of type 2 diabetes prevention. To be most effective, efforts targeting 
children require caregiver engagement and a family-oriented approach. Notably, adult caregivers could 
also benefit from a family-oriented approach to promote health behavior change. To date, however, there 
have been few sustainable or widespread efforts to develop family-oriented diabetes prevention programs 
that have multi-generational impacts. In this research effort, we will conduct a non-randomized pilot 
feasibility study  of a family-oriented Diabetes Prevention Program (FDPP), augmenting the CDC’s 
existing evidence-based Diabetes Prevention Program for adults with additional sessions addressing 
health behaviors in children. A concurrent control group will be enrolled. The primary objective is to 
examine FDPP process measures of feasibility, acceptability and program delivery fidelity. We will also 
preliminarily explore the FDPP’s impact on intervention targets and child and caregiver health behavior 
change and health outcomes.  
We will enroll adult DPP participants who live in households with children ages 18 and under as 
concurrent controls, to compare adult DPP attendance and health outcome measures with the FDPP 
participants. .  
We hypothesize that the FDPP will be feasible to deliver and acceptable to participants.  
 
Objectives  
 
 
The primary objective is to examine FDPP process measures of feasibility, acceptability and 
program delivery fidelity.  
A secondary objective is to preliminarily explore the FDPP’s impact on proximal intervention 
targets (parent/caregiver knowledge, attitudes, self-efficacy and parenting self-efficacy and family home 
environment) and child and caregiver health behavior change and health outcomes. 
 
2. 
Background  
The burden of type 2 diabetes (and related conditions such as obesity) is rising among children in 
the United States and advancing diabetes prevention efforts among high-risk children is a public health 
priority. Efforts that address modifiable risk factors, such as obesity or physical inactivity, have the 
potential to prevent premature type 2 diabetes development, and can also have lasting salutary effects on 
the risk of developing diabetes and other conditions, such as cardiovascular disease, across a child’s life 
course. Further, efforts focusing on low-income and minority children, who have a higher burden of 
modifiable risk factors, can mitigate diabetes-related health disparities. To date, there have been few 
efforts that have effectively targeted modifiable risk factors in children at high-risk for diabetes. 
 
  
Caregiver engagement in the National Diabetes Prevention Program’s (National DPP) lifestyle 
change program represents a novel opportunity to address modifiable diabetes risk factors in high-risk 
children and adults in an effective and sustainable manner. The year-long, evidence-based lifestyle 
change program for adults at risk for type 2 diabetes is a core component of the Centers for Disease 
Control and Prevention’s (CDC) national type 2 diabetes prevention efforts, and is increasingly being 
offered in community-based settings. Children of eligible adults represent a high-risk population, due to 
shared family history, race/ethnicity, and lifestyles. 
  
The evidence-based National DPP curriculum consists of a minimum of 22 modules delivered in 
group settings over 12 months. The program’s effectiveness is ascribed to its comprehensive approach to 
behavior change, including imparting behavioral self-management skills and strategies and frequent 
contact, feedback and support from lifestyle coaches. The program’s content and structure provides an 
ideal backbone for adding supplementary, child-related modules to enable caregivers to develop similar 
skills for children’s health behavior change.    
A family-oriented approach to diabetes prevention programming could also enhance diabetes 
prevention efforts among high-risk adult caregivers. Our preliminary work among caregivers already 
participating in a National DPP lifestyle change program suggests that the opportunity to learn about 
improving child health would have enhanced their interest in program participation. In addition, data from 

 
 
 
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qualitative interviews of former DPP participants who are caregivers of young children, revealed that 
caregivers face unique challenges to lifestyle change that could be addressed via a family-oriented DPP.  
Using this preliminary data, we have created a family-oriented adaptation of the DPP, to be piloted 
via the research efforts described in this IRB application. These proposed research efforts will leverage 
an existing clinical program at Johns Hopkins, the Brancati Center for the Advancement of Community 
Care’s Diabetes Prevention Program.  
 
 
3. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
 
The study design is a non-randomized pilot feasibility study of the Family DPP lifestyle 
intervention compared to a concurrent control group (defined below). in which adult participants (and one 
index child that they care for, who is 5 through 12 years of age at time of recruitment), will be assigned to 
receive the family-oriented of the Diabetes Prevention Program (FDPP) pilot intervention. A separately 
recruited group of adult DPP participants will serve as a concurrent control group. 
Of note, the DPP lifestyle intervention is currently being as a clinical program offered via 
community-academic partnerships by the Johns Hopkins Brancati Center for the Advancement of 
Community Care, with ongoing quality improvement assessment under the IRB protocol “IRB00179397: 
Evaluation of the Johns Hopkins Diabetes Prevention Program.” The DPP intervention as carried out by 
the Brancati Center team consists of streamlined processes for recruitment, eligibility screening, 
enrollment, and continued data monitoring.  
The study procedures as listed below will distinguish research procedures from this “routine 
care.” Of note, the FDPP will consist of all elements of the DPP, with augmentations described as below, 
and thus will involve delivery of at least the standard of care. 
 
Intervention Content Description 
1) The Family Diabetes Prevention Program consists of the CDC’s National Diabetes 
Prevention Program, augmented with additional child-related content. 
 
The CDC’s National Diabetes Prevention Program (DPP), as delivered by the Brancati Center, 
consists of: 
- 
Delivery of the CDC-certified Prevent T2 curriculum, with additional CDC- approved 
modifications, with a total of 32-34 sessions delivered over a 12-month period. In the 
initial “core” period (first 6 months), there are at least 16 sessions delivered on a weekly 
basis. In the “post-core” period, additional (at least 6) sessions are offered over a 6 
month period.  
- 
The sessions are group-based, and led by a CDC-certified lifestyle intervention coach. 
Sessions are delivered either in-person, at community-partner sites or on the JH campus, 
or via a virtual synchronous platform (Zoom).  
- 
The Brancati Center follows all CDC guidelines 
(https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf) with regards to 
program content and data collection. Baseline data collection includes demographics 
relevant to the program. Throughout the program, data are collected on participants’ 
weight, minutes of physical activity, self-monitoring of diet, and attendance. These data 
are currently maintained in a secure, RedCAP database. 
- 
In addition to delivery of the evidence-based, CDC recommended curriculum, the 
Brancati Center team has identified and implemented several strategies to address both 
long-term engagement and barriers to weight loss and dietary modification. These 
include: 
o 
For engagement:  
o 
Providing participants with Progress Charts that show their individual weight loss, 
the average weight loss of their group, and how their group’s weight loss 
compares to other groups 
o 
Offering activities outside of the regularly scheduled group (e.g., informational 
sessions) 

 
 
 
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o 
Engagement campaigns (e.g., “Spring into Summer”) where participants receive 
small incentives (e.g., gift cards, healthy snacks, exercise equipment) for 
attendance, self-monitoring, and being physically active 
o 
Raffles 
o 
Guest speakers 
o For barriers related to weight loss and self-monitoring: 
o 
Grocery store tours 
o 
One-on-one nutrition counseling from a registered dietitian  
o 
Providing sample recipes and food items to trial 
 
2) Adult participants will be engaged in the Family-Oriented Diabetes Prevention Program 
(FDPP). There may be non-study participants (other Brancati Center DP participants) also 
participating in the group (as DPP participants). 
- 
The FDPP has been developed as an augmented version of the DPP. That is, adult 
participants would receive all the above-mentioned elements of the DPP intervention 
(delivered in the same manner as the DPP intervention), with a few augmentations that 
are not intended to alter the evidence-based DPP program, but rather supplement it to 
address caregivers’ own lifestyle change efforts while having children at home AND to 
introduce basic concepts regarding healthy child habits related to dietary intake, physical 
activity and screen time, and sleep. This supplementation/augmentation is achieved via: 
o 
Addition of content to certain DPP sessions that will ensure barriers to/facilitators 
of lifestyle change that other family members (including children) pose to adult 
participants are discussed.  
o 
Addition of 2 supplementary sessions during the core period that will specifically 
discuss making lifestyle changes while being the caregiver of children and 
explore how family members, including children, serve as motivation for lifestyle 
change.  
o 
Child-focused sessions in the “post-core” period of the DPP (see supplementary 
material which includes proposed schedule), which will be delivered to adult 
participants, and accompanied by separate sessions for children. Adults and 
children will first present together for the child-focused sessions, then separate, 
and come together at the end. At the end, adults and children will convene to 
discuss what they learned and come up with basic child or family health behavior 
goals related to the health behaviors.  These sessions discuss pediatric 
guidelines or recommendations endorsed by the American Academy of 
Pediatrics or other relevant national society (e.g., Centers for Disease Control 
and Prevention, American Heart Association), and will also cover strategies and 
tips to enable caregivers to support children in achieving these goals. The topics 
to be covered will include:  
 
MyPlate (discussing MyPlate guidelines, and how to achieve variety and 
balance in meals for children) 
 
Fruit and Vegetables (discussing guidelines around children’s intake and 
tips and strategies to increase fruit and vegetable intake) 
 
Sleep (discussing sleep recommendations, including how to promote 
sound sleep of good quality in children) 
 
Reducing Sugary Beverages (discussing sugar intake guidelines and 
how to promote healthier beverage consumption) 
 
Physical Activity (discussing physical activity guidelines and how to 
support kids to be active on a daily basis) 
 
Screen time (discussing screen time guidelines, smart screen time use 
and strategies to help limit children’s screen time) 
 
Family Exercise Activity (a session in which adults and children will be 
guided through a fun physical activity, such as Zumba). 
 
Family Cooking Activity (a session in which adults and children will be 
guided through preparing a healthy meal.) 
o 
A sample Family DPP schedule included in this IRB application under 
“Supplementary Material.” 

 
 
 
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3)  Note on children as participants in the FDPP: Both the FDPP and National DPP 
interventions are intended to be delivered primarily to the adult participant (caregiver of the 
child). For the FDPP, children may be present during child-focused modules as noted above. 
During these sessions, the children will engage in age-appropriate activities, games and 
discussions to learn basic concepts about healthy lifestyle behaviors. This would be done 
separate from the adult caregivers (a separate room or Zoom room, if possible\), and then 
they will join the adult caregivers at the end of the session for a group discussion.  
 
4) Concurrent Control Group: The adults in the concurrent control group will be recruited (as 
detailed below) from participants in the Brancati Center’s Diabetes Prevention Program.  
 
Recruitment, Screening Eligibility and Enrollment: Intervention Arm  
 
 
Recruitment for Intervention Arm: 
We will recruit adult participants, and one index child, through several means as detailed in  
“Section 13”.” This will include 
1) Recruitment from adults who are outreached for the Brancati Center's Diabetes Prevention 
Program. After these adults are deemed eligible for the Diabetes Prevention Program for 
screening, they would be asked the following question by Brancati Center DPP team 
members “There is a research study for DPP participants that you may be eligible for. This 
study involves adults in the DPP and children ages 5 through 12 years that they care for. As 
part of the study, you would be enrolled in a “family-oriented” version of the DPP, which 
would include some sessions related to children’s healthy behaviors in the second half of the 
program. In addition to you participating in the DPP, you and one child would be asked to 
complete surveys and provide some other data 3 times during the program, and potentially 
participate in an interview after the program. You would be compensated $50 for each of the 
data collection points. Would you be interested in learning more about the study?” If potential 
participants are interested, their contact information would then be provided to the Family 
DPP study team for recruitment and screening eligibility.  
 
 
2) Flyers in clinical sites and community partner sites, with the flyer also posted to the 
Brancati Center's Facebook Page and website. We will also request community partner 
organizations in Baltimore to disseminate the flyers to their community members (such as 
through through in-person events, via e-mail or with announcements, or by posting on their 
social media sites). We will also advertise via paid Facebook advertisements. We will also 
request community partner organizations in Baltimore to share with their community 
members including at in-person events and via e-mail or by posting on their social media 
sites. We will also advertise via paid Facebook advertisements. The flyers will have a contact  
study email and also phone number for participants to call. The phone number will be that of 
a study team member; the email will only be accessible to study team members. A telephone 
screening script will be used when a study team member discusses the study with potentially 
interested participants, to assess eligibility. If a participant provides their email address as 
contact information, we will outreach via telephone and also if needed via email from the 
FamilyDPP@jh.edu email account. 
The email outreach will read: 
"Thank you for your interest in the Family Diabetes Prevention Program Pilot Study. 
(We have tried to reach you also via the telephone number you provided [note: this will be 
included if applicable]). 
 You may also reach us via calling (410-955-9869 or 443-540-5295), or responding to this 
email with the phone number you would like us to call and/or if there are specific days or 
times you would like us to call you. 
 Thank you again for your interest. 
 Sincerely, 
 Maya Venkataramani MD, MPH 
 Principal Investigator 

 
 
 
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 Family Diabetes Prevention Program Pilot Study 
 
 
3) Recruitment from clinical providers (NPs, PAs or physicians) at sites such as East 
Baltimore Medical Center (if approved by JHCP Research committee). The study team will 
present to providers at this site to describe the study and general eligibility criteria; providers 
will be provided flyers. Providers will be asked only to provide the patient's name and contact 
information via a secure email to the study team. They will be asked to document in the chart 
"I discussed the referral of the patient to the Family Diabetes Prevention Program team for 
the Family DPP pilot study. The patient agreed to the referral." 
 
4) Recruitment via the Johns Hopkins ICTR's Johns Hopkins Studies Facebook Page, which 
includes Facebook advertising via the ICTR to recruit study participants for Johns Hopkins 
Studies; the Facebook Ad Plan is uploaded as a document in question 13. 
 
Screening eligibility for Intervention Arm 
Potential adult participants who are referred by the Brancati Center DPP team as per their 
interest in learning more about the study, will have already undergone screening to ensure 
they meet DPP-related inclusion criteria (are eligible as adults for participation in the DPP), 
as per routine protocols for the DPP. Screening of these adults for additional inclusion criteria 
for the study (e.g., being a caregiver of an eligible child), will be conducted by a study team 
member via a separate outreach call. For those potential adult participants recruited via other 
means, the study team member will also conduct DPP eligibility screening as per the Brancati 
Center’s practices. 
 
For child participants, screening eligibility will be conducted via the adult participant. It is 
possible, given the definition of caregiver that is used, that the caregiver may not be able to 
answer specific questions regarding the child’s inclusion criteria. If this is the case, the child’s 
parent or legal guardian will be contacted to confirm the child’s eligibility. 
 
If a caregiver has more than 1 child in the eligible age range, the study team member 
conducting the screener will use a random number generator to select one child randomly, 
and assess the eligibility of this child. If the child is not eligible, then the next child’s eligibility 
will be assessed. If the caregiver expresses a strong desire to assess the eligibility of a 
certain child in particular, then the study team member will be advised to start with the 
eligibility screening of this child. 
   
 
 
Enrollment of the Intervention Arm 
- 
Enrollment of adult participants (and child participants) in the intervention arm, after 
eligibility screening, completion of adult consent process and the child assent (with parent 
or legal guardian consent) process (Details regarding consent and assent as detailed in 
Sections 14-17 of the eIRB application).  
- 
Any related enrollment processes related to the adult participant’s participation in the 
DPP as routine care, will be conducted by the Brancati Center team as per routine 
practices for DPP enrollment.  
- 
For the child, the enrollment form will confirm parent/legal guardian contact information 
(emergency contact information), the child’s pediatrician, and food or other allergies to be 
aware of. 
 
 
Randomization 
- 
Participants will not be randomized to the intervention. All participants who are recruited 
for the intervention arm will be engaged in the FDPP intervention. 
 
Recruitment and Screening Eligibility: Concurrent Control Group (Control Arm) 
Recruitment of Concurrent Control Group (Control Arm):  

 
 
 
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The concurrent control group will consist of adults in the Brancati Center's DPP (who 
started the program within 6 months of the Intervention group) and who have children less 
than 18 years of age living in their household. We will recruit adult participants for the 
concurrent control groups through several means as detailed in “Section 13”.” This will 
include 
 
1) Recruitment from adults currently participating in Brancati Center DPP groups (which 
have started within 6 months of the Intervention Arm groups): During a DPP session, 
participants will be read a brief paragraph regarding the concurrent control group as follows 
and a flyer will also be distributed to group participants via email: 
 
“There is a research study for DPP participants that you may be eligible for. This study 
involves adults in the DPP who have children less than 18 years living in their household. As 
part of the study, you would be asked to complete surveys once. The study team would also 
compare participants’ DPP attendance and outcome data with that of other adult participants 
who are enrolled in a Family Diabetes Prevention Program pilot study. You would be 
compensated for your time.” 
 
 
If potential participants are interested, their contact information would be provided to the 
Family DPP study team; contact information of the study team would also be provided.  
 
 
2) Recruitment from adults who are to start a Brancati Center DPP program: Individuals 
who are enrolled in (assigned to a DPP group, but not yet started) will be read the following 
during routine telephone calls conducted prior to group start:  
 
“There is a research study for DPP participants that you may be eligible for. This study 
involves adults in the DPP who have children less than 18 years living in their household. As 
part of the study, you would be asked to complete surveys once. The study team would also 
compare participants’ DPP attendance and outcome data with that of other adult participants 
who are enrolled in a Family Diabetes Prevention Program pilot study. You would be 
compensated for your time. Would you be interested in learning more about this study?” 
 
Screening eligibility for the Concurrent Control Group (Control Arm) 
Potential adult participants will be screened for eligibility for the concurrent control group by 
the study team via telephone.  
 
 
 
Intervention Delivery (Family DPP) 
 
-  The Family DPP intervention itself will be delivered as per routine care practices of the 
Johns Hopkins Brancati Center’s Diabetes Prevention Program. Currently, the program is 
being delivered via a distance-learning modality (Zoom) to participants, in the setting of the 
COVID-19 pandemic. Thus, we anticipate that participants will receive the Family DPP in a 
distance-learning format; there may be the possibility of certain sessions held in-person either 
at our community partner site or in a conference room of appropriate size on the Johns 
Hopkins East Baltimore medical campus. We will at the minimum follow Johns Hopkins 
related guidance regarding in-person gathering size restrictions and other precautions 
(physical distancing, masks). 
 
- 
If the enrolled adult study participant is not the parent or legal guardian of the child for 
whom they identified as a caregiver as per our eligibility definition, then we will request 
the parent or legal guardian to complete a permission slip for the child’s attendance to 
any session or study visit (uploaded in the eIRB application, Supplementary Materials).  
 
 
 
Data Collection for Intervention Arm 
 
1) Data collection associated with Routine Care (DPP protocol): 
o 
Adult-related outcomes: Adult participants who are part of the Brancati 
Center’s Diabetes Prevention Programs (in this scenario, this will include those 
adults who are receiving Family DPP as well), will have data collected relevant to 
their participation in the program, as per the routine care protocol. This includes 
data collected as part of the DPP eligibility screening process and program 

 
 
 
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enrollment process. During the program, this includes participants’ attendance, 
weight (either measured if in-person visits, or self-reported) and self-reported 
physical activity minutes. 
 
2) Data collection associated with the study:  
o 
Survey instruments are included in the Supplementary Materials section of this 
eIRB application.   
o 
Process Measures: Measures of program feasibility (other than caregiver 
attendance, which will be collected as per the DPP protocol as above), including 
recruitment rate, child attendance, child outcome measurement completion, 
survey administration time and cost (per group) will be tracked during the study 
by study team members. Measures of acceptability will be collected via a 
survey tool administered to the adult participants after each child-focused 
session and at the end of the program (the surveys maybe administered either 
via telephone, in-person or participants may be asked to complete the survey via 
a secure RedCAP link). Measures of fidelity in Family DPP delivery will be 
collected via a Fidelity Checklist tool that will be completed by a study team 
member who will observe the child-focused sessions (being delivered to the adult 
participants). In addition, coaches will be asked to complete a Coach Reflection 
sheet at the end of each child-focused or child-related session, which will make 
note of any timing-related issues with content delivery and content-specific 
issues (graphics that were unclear, discussion points that should be included in 
future iterations of the material, etc.) 
o 
Adult-related outcomes: For adult participants, we will conduct surveys at 
baseline, around 6 months (after completion of core period of DPP or Family 
DPP curriculum) and at the end of the program (12 months). These surveys will 
cover domains including: household demographics, child demographic 
information, household social determinants of health, adult health behaviors, self-
efficacy for behavior change, and parenting self-efficacy. These surveys will be 
administered either in-person, via telephone or via RedCAP link.  
o 
Child-related outcomes: For child health behavior outcomes, the adult 
participant will be asked questions regarding child health behaviors (physical 
activity, screen time, fruit and vegetable intake, sugary beverage intake, sleep 
duration). For children ages 9 through 12 years, we will also ask these questions 
directly of the child; the child will be interviewed with their caregiver present, 
either in-person or via telephone. For child health outcomes, specifically 
change in BMI z-score, we will collect child height and weight in-person. This 
will be done in a private space at the community-partner site or the JHM campus 
(offices of the Brancati Center) or at a location of the participant’s preference or 
choosing.  
o 
As per our Data Safety Monitoring Protocol outlined in Section 32 of the IRB 
application, we will query participants about possible adverse events using the 
Adverse Events form at 6 and 12 month data collection points. 
 
 
Data Collection for Concurrent Control Group (Control Arm) 
1) Data collection associated with Routine Care (DPP protocol): 
o 
Adult-related outcomes: Adult participants who are part of the Brancati 
Center’s Diabetes Prevention will have data collected relevant to their 
participation in the program, as per the routine care protocol. This includes data 
collected as part of the DPP eligibility screening process and program enrollment 
process. During the program, this includes participants’ attendance, weight 
(either measured if in-person visits, or self-reported) and self-reported physical 
activity minutes. 
2) Additional data collection for concurrent control group: For adults in the concurrent 
control group, we will conduct a baseline survey. This survey will cover domains 
including: household demographics, child demographic information and household social 

 
 
 
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determinants of health. The survey may be conducted over telephone or via secure 
REDCap online link (self-administered).  
3) Also, as per our Data Safety Monitory Protocol outline in Section 32 of the IRB 
application, we will query participants about possible adverse events using the Adverse 
Events form at 6 and 12 month time points via telephone. 
 
b. If your study involves data/biospecimens from participants enrolled under other 
research studies with a written consent or under a waiver of consent, please list the 
IRB application numbers for those studies.  Please note:  Certificate of 
Confidentiality (CoC) protections applied to the data in source studies funded by NIH 
or CDC will extend to this new study if the funding was active in 2016.  If this 
situation applies, Section 36, question 6 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. 
 
For both the adult intervention arm participants and concurrent control group (control arm) 
participants, we will obtain adult participant attendance data, as well as weight and physical 
activity data, from the Brancati Center’s Diabetes Prevention Program participant database; these 
activities are undertaken under IRB protocol “IRB00179397: Evaluation of the Johns Hopkins 
Diabetes Prevention Program.”  
 
c. Study duration and number of study visits required of research participants. 
 
For Intervention Arm: 
Study participants would be engaged for approximately 12-14 months.  
This time period would involve the delivery of the family-oriented DPP (or control group would 
receive DPP) lifestyle intervention, during which we would have 3 study-specific visits (at 
baseline, 6 months and 12 month data points). 
 
For Concurrent Control Group (Control Arm): 
Study participants would be engaged for one telephone-based survey administration call.  
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
We will not be blinding participants in this pilot study. It would not be feasible to blind participants 
in the 2 different arms/groups, as they are receiving different interventions (Family DPP versus  
being enrolled in the DPP).  
 
e. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
 
Not applicable; the DPP itself is deemed routine care for adults with prediabetes, and 
enrollment in DPP does not interfere with receipt of other routine medical care. The family-
oriented version of the DPP (FDPP) will consist of all elements of the DPP, with additional 
augmentations with respect to family or child-oriented content, as described earlier, and 
similarly will not interfere with receipt of other routine medical care for adults or children. 
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
We have revised our study protocol from the original version (dated 4/20/22), to enroll all 
eligible study participants in the intervention arm. But we will plan on enrolling adult DPP 
participants with children under the age of 18 in a concurrent control group. This concurrent 
control group would consistent of adult participants of the Brancati Center’s DPP program 

 
 
 
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who are living in a household with children. In this control group, we would examine adults’ 
attendance and DPP outcomes related to weight loss and physical activity group. This would 
enable us to preliminarily explore differential impact of the FDPP versus DPP on adult health 
outcomes, informing elements of a larger comparative effectiveness trial comparing the 
FDPP versus the DPP. 
 
g. Definition of treatment failure or participant removal criteria. 
 
The DPP (and FDPP) interventions are designed for prevention of type 2 diabetes in adults with 
prediabetes. Some adult participants may progress to type 2 diabetes while participating in the 
FDPP; the CDC’s guidelines are that these individuals can remain in the DPP lifestyle 
intervention (given the benefits of lifestyle modification). The Brancati Center team confers with 
the participant’s primary care provider if this were to occur (development of type 2 diabetes) to 
confirm that the participant is recommended to continue in the DPP. 
 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
Participants will be instructed to continue with routine medical care when the program ends or 
if their participation ends prematurely.   
 
i. If biological materials are involved, please describe all the experimental procedures 
and analyses in which they will be used. 
 
 
Not applicable. 
 
4. 
Inclusion/Exclusion Criteria 
 
Intervention Arm 
The study will enroll adult-child dyads in the Intervention Arm. 
 
Adult inclusion criteria will include meeting all of the following:  
1) CDC national criteria for enrollment in the DPP (as used by the Johns Hopkins Brancati 
Center’s DPP programs): 
• Be 18 years of age or older and not pregnant at time of enrollment 
• Have a body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if Asian American). 
• Meet either one of the criteria 
1. Have a recent (within the past year) blood test meeting one of these 
specifications:  
 i. Fasting glucose of 100 to 125 mg/dl (CMS eligibility requirement for 
Medicare DPP suppliers is 110 to 125 mg/dl)  
 ii. Plasma glucose measured 2 hours after a 75 gm glucose load of 140 
to 199 mg/dl  
 iii. A1c of 5.7 to 6.4%.  
2. Clinically diagnosed gestational diabetes mellitus (GDM) during a previous 
pregnancy 
3. A positive screening for prediabetes based on the CDC or American Diabetes 
Association Diabetes Screening Test (a brief questionnaire) 
 
2) being a primary caregiver of at least one eligible child aged 5 through 12 years at time of 
recruitment (defined as caring for the child, with a responsibility for the child’s food, sleep and 
activity habits,at least 3 days out of the week) 
 
 

 
 
 
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Exclusion criteria for adults will reflect CDC national DPP exclusion criteria. Specifically, adults 
will be excluded if they are: 1) pregnant; 2) have end-stage renal disease; 3) have type 1 or type 
2 diabetes. They will also be excluded if they are concurrently enrolled in a structured weight 
management program.  
 
Children for whom the eligible adult is a primary caregiver (parent or guardian who cares for the 
child 3 or more days out of the week), will be considered eligible participants if 1) they are aged 5 
through 12 years at time of recruitment; 2) they do not have a medical condition which leads to 
inability to comply with general pediatric dietary or physical activity goals; and 3) they are not 
concurrently enrolled in a structured weight management program.  
 
Concurrent Control Group 
Inclusion criteria for adults in the control group will include meeting all of the following:  
1) Participant in the Brancati Center’s Diabetes Prevention Program, in a group that has started 
within 6 months of Intervention Arm group start 
2) Lives with a child less than 18 years of age in their household 
 
 
5. 
Drugs/ Substances/ Devices – Not applicable 
 
6. 
Study Statistics 
a. Primary outcome variable. 
 
Primary outcomes will examine process measures. 
These will include:  
I. 
Feasibility measures (measuring recruitment, retention and measurement of outcomes, 
cost): 
a. Recruitment rate, measured as % of eligible caregivers consented to study/time 
b. Caregiver attendance, defined as % of adult, child-focused and all sessions attended 
c. Child attendance, defined as % of sessions requiring child participation attended 
d. Survey administration, defined as mean time for administration of surveys 
e. Total cost per group of program delivery 
 
II. Acceptability measures 
a. Including mean scores on Likert scale-based questions re: satisfaction with 
program content & structure, willingness to recommend to others 
III. Fidelity, as measured by a fidelity checklist that will be completed by a study team 
member observing the child-focused sessions (specifically, the child-focused 
sessions delivered to adult participants), and will include measures: 
a. % of tasks/content delivery per session from coach checklist 
b. Total & average scores per domain from observer checklist 
 
b. Secondary outcome variables. 
 
Secondary outcome variables will preliminarily examine: 
1. Proximal intervention targets 
a. Caregiver (adult participant) knowledge and attitudes towards healthy-related 
behaviors  
b. Perceived self-efficacy for behavioral change 
c. Parenting self-efficacy for behavioral change 
d. Family Home Environment  
2. Caregiver (adult participant) Health behaviors and health outcomes 
a. Physical activity- total minutes of moderate/vigorous physical activity in weeks 
preceding and whether caregiver meets DPP physical activity goal of 150 minutes/week 
of moderate-vigorous physical activity; and dietary  
b. Dietary patterns  

 
 
 
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c. Percent weight loss from baseline 
3. Child health behavior and health outcomes 
 
a. Physical activity- minutes/day 
 
b. Screen time (hours/day) 
 
c. Fruit and vegetable intake 
 
d. Sugary beverage intake 
 
e. Sleep duration and sleep behaviors 
 
f. BMI z-score change 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
As the main objective of this study is evaluating FDPP feasibility and acceptability measures, 
sample size is primarily informed by budgetary constraints and our experience recruiting 
individuals for the DPP as well as recruitment for the study thus far. 
 
Feasibility, acceptability and fidelity measures will be analyzed with descriptive statistics (Table 
2). Intervention targets will be analyzed as continuous variables (means or numerical scores). 
Caregiver and child health behaviors will be analyzed as continuous variables (average 
value/day) and a binary variable (achievement of goal). The caregiver health outcome will be 
modeled as a continuous variable (percent of weight loss from baseline) and binary variable 
(achievement of 5% weight loss goal). The child health outcome is the BMI Z-score, a continuous 
variable. Within-groups, we will use 1) paired-t tests to analyze pre-post changes (from baseline 
to 6 months and baseline to 12 months) of continuous variables; and 2) McNemar’s exact test to 
examine pre-post changes in proportion achieving behavioral and outcome goals (binary 
variables). Between groups, we will use 1) 2-sample t-tests to compare the magnitude of mean 
group change in values of continuous variables; and 2) Fisher’s exact test to compare proportion 
achieving goals at 6 and 12 months. If continuous variables do not meet distribution assumptions 
necessary for use of parametric tests (t-tests), we will use appropriate non-parametric tests 
(Mann-Whitney test or, for paired data, Wilcoxon signed-rank test). 
 
d. Early stopping rules. 
 
Not applicable. 
 
7. 
Plan for reporting unanticipated problems or study deviations. 
 
The plan below is specifically for the Intervention Arm. 
 
The PI (Dr. Venkataramani) and co-I (Dr. Maruthur) will bear the responsibility for data and safety 
monitoring. An independent data safety monitor (Dr. Scott Pilla, Assistant Professor, General Internal 
Medicine) will be employed as well as below. 
 
During data collection points at 6 and 12 months, adult participants  would be queried about possible 
adverse events (AEs), specifically interim ED visits or hospitalizations, for both themselves and the child 
enrolled in the study. (see uploaded Adverse Events form). Any and all adverse events would be 
reviewed by the PI, Dr.  Maruthur as co-I and also the independent safety monitor for review; adverse 
events will be reported to the Johns Hopkins School of Medicine IRB, as well as NIH project office 
according to the prevailing policies of these review bodies. Study team members will receive training 
regarding adverse event documentation and reporting. 
 
In addition, adult weight changes and child BMI changes will also be reviewed as follows: at 6 and 12 
months, a research team member will send to the independent study monitor a report with participant 
study ID, age and % weight change for adults or change in BMI for children over the past 6 months. 
Significant changes in adult weight or child weight-for-height over the review period will prompt the 
independent safety monitor to notify Dr. Venkataramani or Dr. Maruthur to refer the participants to their 
primary care physician for additional evaluation. 

 
 
 
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Of note, the Brancati Center DPP clinical program has team members who provide medical oversight of 
all participants in the DPP, and adult participants in the study will also be under this as per routine care. 
During weekly team meetings as part of routine care, adult participants weight changes are reviewed for 
all participants. 
 
8. 
Payment and Remuneration 
 
Intervention Arm 
Specific to study procedures, the adult participant (as the representative of the adult-child dyad) 
will be remunerated via $50 gift cards with completion of data collection at each time point 
(baseline, 6 month, 12 month), for a maximum of $150 related to study procedures In addition, 
the Brancati Center’s DPP provides program-related supports that will continue to be the same 
for all participants. 
 
Concurrent Control Group (Control Arm) 
Specific to study procedures, the adult participant will be remunerated with a $30 gift card with 
completion of the single data collection point.