Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
Phase: NA
Conditions: Pregnancy Related
Sponsor: Arkansas Children's Hospital Research Institute

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 1 
 
 
Study Title: 
Community Translation of the Expecting Study 
 
Principal Investigator:  
Taren Swindle, PhD 
University of Arkansas for Medical Sciences 
521 Jack Stephens Drive, Slot # 531 
Little Rock, AR 72205 
Telephone:  870-236-0997 
Email:  tswindle@uams.edu 
 
Co-Investigators:  
Aline Andres, PhD 
 
Elisabet Borsheim, PhD 
 
Study location: 
 
Arkansas Children’s Nutrition Center 
University of Arkansas for Medical Sciences (secondary) 
 
 
 
 
 
Support (Funding): 
Arkansas Children’s Nutrition Center  
United Stated Department of Agriculture 
 
Clinical Trial Registry: 
Not Yet Assigned 
 
 
 
 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 2 
 
Table of Contents 
 
Table of Contents ............................................................................................................ 2 
Abstract ........................................................................................................................... 3 
Background and Rationale .............................................................................................. 3 
Theoretical Foundation ................................................ Error! Bookmark not defined. 
Objectives ....................................................................... Error! Bookmark not defined. 
Study Design and Procedures ......................................................................................... 4 
Study Design ............................................................................................................... 4 
Study Population, Inclusion, and Exclusion ..................................................................... 6 
Inclusion Criteria .......................................................... Error! Bookmark not defined. 
Exclusion Criteria ......................................................... Error! Bookmark not defined. 
Risks and Benefits........................................................................................................... 6 
Data Handling and Recordkeeping ................................................................................. 7 
Data Analysis .................................................................................................................. 7 
Ethical Considerations ..................................................................................................... 8 
Dissemination of Data ..................................................................................................... 8 
References ...................................................................................................................... 9 
 
 
 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 3 
 
Abstract 
The proposed research is a sub-objective of a larger research study lead by Dr. Aline 
Andres. This protocol has one primary aim:  
Adapt and determine acceptability, feasibility and fidelity of the Expecting intervention 
with pregnant obese women in community settings.  
The Expecting intervention as delivered in prior studies in a clinical setting is described 
in a previous approved IRB submission (Protocol 202954). The current project will seek 
to engage community stakeholders to translate Expecting to a community-delivered 
intervention and to test its acceptability, feasibility, and fidelity in a proof of principle 
study with 60 expecting mothers. At the time of this submission, we are seeking 
approval for the first year of activities of the project only. This is because 
community stakeholder input will direct the future stages of the project including 
recruitment, assessment, and delivery of the intervention. We will seek approval for 
additional years of the project prior to their activities, and we describe them in general 
terms in this submission.  
Background and Rationale 
Expecting is a study of exercise training in sedentary pregnant women with obesity. 
Training visits are led by a coach 3 times per week with components of both aerobic 
and resistance exercise. The Expecting intervention has shown strong compliance and 
promising results in a clinical setting. The preliminary results of the Expecting 
intervention suggest a need for preparation for large-scale tests in community settings. 
One question is whether or not such a program is feasible in a “real-world” environment. 
We will use an implementation science approach, a specific field of translational 
science, to translate the Expecting intervention to community settings. Implementation 
science emphasizes monitoring fidelity to the protocol, reaching the target population 
with the right intervention dosage, and maintaining the intervention across time.1 
Intervention implementation is more likely to achieve these outcomes with stakeholder 
input.2 The Replicating Effective Programs (REP) strategy provides a four-phase 
process for implementing evidence-based interventions and has demonstrated effective 
application to translate clinical interventions to community settings.3–7 Built into the REP 
framework is the collection of feedback from community stakeholders, iterative piloting 
of the intervention in the community, and a process for standardizing the intervention 
across community settings. Application of the REP framework will provide a strong 
approach to adapt and pilot test the feasibility of a pregnancy exercise intervention in a 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 4 
 
community setting. We expect that REP will provide an adequate implementation 
strategy to ensure desired levels of fidelity and adoption for three key reasons. First, 
REP has a strong evidence base as a proven implementation strategy. Second, REP 
includes a rigorous and structured process of stakeholder engagement, which will 
ensure that perspectives of those targeted by the intervention are represented in the 
adaptation. Third, throughout the pilot study, we will conduct a rigorous process 
evaluation8 monitoring fidelity and adoption of the Expecting protocol. 
Hypothesis 
Our hypothesis is that a community-adapted Expecting intervention will demonstrate 
acceptability, feasibility and fidelity among participating pregnant women. Specifically, 
we will show effective application of the REP framework (e.g., fidelity, feasibility, 
acceptability) to translate the Expecting intervention to community settings. 
Study Design and Procedures 
Design 
REP will provide the structure and process for 
translating and piloting the Expecting 
intervention in a community setting. The first 
year will focus on Phase one of REP. The 
activities of this phase are detailed in Table 1. 
To complete the steps of the REP shown in 
Table 1, we will complete up to 3 focus groups 
with past participants in the fitness center based 
Expecting study at ACNC, and 10 qualitative 
interviews (outlined in the interview guide 
document) with current study participants.  Past participants will be asked to discuss 
their barriers and facilitators to participation in the study protocol. Importantly, we will 
further solicit suggestions for how they would change or adapt the program to be 
deliverable in their local community setting. Current participants will provide similar 
information; however, their perspective will have the benefit of drawing on recent and 
ongoing participation in the Expecting Study protocol.  Both sets of interviews will be 
informed by the Consolidated Framework for Implementation Research 9,10 to guide the 
constructs targeted for interviews.  (See Community Expecting Interview Guide). 
Table 1. REP Phase 1 
Pre-Conditions development 2019 -
2020 
- Assess potential barriers.  
- Adapt intervention to fit community 
setting. 
- Package intervention for community 
setting (e.g., core elements versus 
menu options). 
- Package training, promotional 
materials, & assessment forms.  

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 5 
 
Trained researchers in qualitative research will also use spontaneous probing questions 
to clarify or further elicit information on important points. In addition, focus groups will 
apply by Liberating Structures11 and the Nominal Group Technique12 to solicit 
participant input.  That is, both the qualitative interviews and focus groups will cover the 
same content (See Expecting Community Interview Guide). However, we are requesting 
to format some questions with interactive techniques as designated with an asterisk on 
the guide. For example, we might use a “1-2-4 All” Liberating Structure to ask 
participants to write their barriers (Q11) on their own (1) and then to discuss and 
combine with a partner (2) and then small group (4). This encourages representation 
and capturing of all perspectives without an individual having to speak up in front of the 
whole group. As another example, we could employ the Nominal Group Technique to 
facilitate brainstorming on how the Expecting protocol could be translated to the 
community (Q7). These techniques can serve to redistribute power in the group if a 
couple participants begin dominating the conversation or if some participants do not 
seem engaged in participation. We are requesting the flexibility to use these techniques 
as the dynamics of the group unfold and as time allows. The PI and Research Assistant 
will co-lead interviews and are experienced with facilitating focus groups and use of 
these techniques. We would not cover any additional topics than what is included in the 
interview guide.  Participants in both focus groups and interviews will be provided a 
snack in addition to a $25 incentive. We expect the focus groups and interviews to last 
60-90 minutes. 
We will also form an advisory stakeholder panel comprised of community leaders and 
relevant stakeholders to the future phases of the project (e.g., WIC staff, Early Head 
Start director, faith leaders, community center staff, gym partners). These panels will be 
conducted consistent with principles of Evidence Based Quality Improvement (EBQI) 
approaches.13–15 EBQI is a flexible process conducted across a series of meetings with 
topic-driven agendas; each session will last 2 hours. We expect to hold between 3 and 
6 EBQI meetings over the coming year. First, the research team will present a summary 
of interview findings, conduct a “member checking” exercise with participants to check 
the validity of findings, and reach consensus on key barriers and facilitators that will 
drive the adaptation of the Expecting study protocol for the community. Next, we will 
present potential adaptations and implementation strategies informed by the Expert 
Recommendations for Implementing Change (ERIC),16 taxonomy of implementation 
strategies with consideration of the theoretical domains of behavior change.17 To reach 
a consensus on the implementation strategies, we will use techniques outlined by 
Powell et al,79 including concept mapping. This method provides quantifiable information 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 6 
 
and promotes efficient collection of input in real time. Then, we will present the draft 
strategies/tools, training, promotional materials, & assessment forms. We will collect 
feedback for revisions, and receive final approval to pilot test them. In later sessions 
(after the pilot is initiated), we will present data from the pilot study to inform iterations 
and improvements to the approach. Stakeholders will be paid out-of-county travel costs 
and a $50 incentive for each session; snacks will be provided.  
Study Population 
For this phase of the study, there are two primary target populations: (1) prior and 
current participants in the Expecting Study and (2) community stakeholders with 
relevant perspectives to inform recruitment and conduct of our pilot study.  
Recruitment 
Past participants will be recruited based on their compliance to the Expecting Study 
protocol if they agreed to be contacted for future research studies. That is, we will target 
those with both high compliance in attending physical activity sessions and those that 
demonstrated lower compliance. To identify possible participants, the Expecting PI will 
provide a list of the top and bottom 10% of participants in regard to compliance. We will 
randomly select and recruit participants until we reach our target of 24 participants to 
participate in one of three focus groups. Focus groups will include one consisting of 
participants from the high compliance group, one with participants from the low 
compliance group, and one mixed. This will maximize the diversity of interactions we will 
solicit.   
Current participants will be recruited from the pool of participants currently taking part in 
the Expecting Study at the ACNC. The PI will consult with ACNC study staff to identify 
and approach eligible participants.  
Stakeholders for EBQI panels will be recruited based on their unique perspective to 
assess opportunities and challenges to translation of the Expecting Study to a 
community setting. We have existing partnerships with the targeted sectors, and we will 
request nomination of a delegate from each sector for attendance at EBQI sessions.  
Risks and Benefits 
As in all research, there exists the potential risk to study participants of loss of 
confidentiality.  Measures to protect the confidentiality of study participants will be 
implemented, including secure storage of all study data on encrypted servers or locked 
file cabinets on ACNC campus.  No physical risks related to participation in this study 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 7 
 
are foreseen.  Some women may experience discomfort as a result of answering 
questions that they consider personal in nature.  This risk will be minimized by their 
ability to withdraw from the study or to refuse to answer any question which makes them 
uncomfortable. 
There may be some indirect benefit to participants taking part in this study. As we learn 
about the adaptations needed to translate physical activity interventions for expecting 
women in the community, we can contribute to the health of women in the community 
through offering programs in collaboration with our community partners. It is also 
possible that participants will experience no direct benefit as a result of participation. 
Data Handling and Recordkeeping 
The PI will carefully monitor study procedures to protect the safety of research subjects, 
the quality of the data and the integrity of the study.  All study subject information 
obtained will be summarized without identification.  Participants will have no identifying 
information linked with their responses.  Study documentation will be kept in a locked 
file in the principal investigator’s office, if hardcopy, or on a password-protected server. 
The interview tapes and transcriptions will be de-identified. We will retain the audio 
tapes until 7 years from the final reporting of the study at which point they will be 
destroyed. De-identified transcripts will be retained by the study team indefinitely to 
inform future projects. Identifiers necessary to execute the project (for the purpose of 
contact, scheduling, and payment) will be stored on secure ACNC severs. Any related 
physical copies of information will be locked in UAMS file cabinets in badge-access 
buildings while in use for the project (e.g., until analysis is complete). All files will 
ultimately be stored at the ACNC. We will destroy identifiers and contact of study 
participants after final data collection and analysis are complete and results of the 
project shared with participants. We expect this to take up to 7 years.   
Data Analysis 
Formative phases (pre-conditions and pre-implementation development) will produce 
valuable qualitative information on the process of engaging stakeholders in the 
adaptation of a clinical intervention for community sessions. All activities in these 
phases will be captured with audio recording to facilitate transcription and coding. We 
will apply best practices in qualitative analysis for implementation science and employ a 
hybrid of deductive and inductive thematic analyses techniques.18,19   

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 8 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and 
procedures.  This protocol and any amendments will be submitted and approved by the 
UAMS Institutional Review Board (IRB) to conduct the study. 
A waiver of documentation of consent is requested for the project as this research 
involves no more than minimal risk to the subjects, and waivers of documentation of 
consent will not adversely affect the rights and welfare of the subjects. For these aims, 
the only record linking the subject and the study would be the consent document 
making the principal risk a breach of confidentiality.  Therefore, we are requesting 
verbal consent consistent with the language in the interview guide.  
Dissemination of Data 
We will employ a multi-pronged strategy to ensure that findings from this research are 
disseminated to scientists and community stakeholders. These efforts will not contain 
any identifiable information that could be linked to a participant. 
Scientists. We will disseminate these findings to scientists with interests in physical 
activity and maternal and child health. We plan to present our findings at premier 
conferences such as the International Society for Behavioral Nutrition and Physical 
Activity and the Science of Dissemination and Implementation. Additionally, we will 
submit findings for publication to appropriate journals in the field such as Pilot and 
Feasibility Studies. We will also share abstracts and publications with academic 
listservs and professional social networking sites on which we are members. 
Community Stakeholders.  Expecting mothers and those providing services to this 
population (e.g., WIC, Head Start, and healthcare providers) are primary stakeholders in 
the findings of this research. We will share back findings of all stages of the project to 
participants and partnering agencies. We will also send a thank you letter to participants 
involved this project, which will summarize our findings and next steps. 
 
 

Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 9 
 
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Study Title: Community Translation of the Expecting Study 
PI: 
 
Taren Swindle, PhD 
Institution: 
University of Arkansas for Medical Sciences 
Support: 
USDA  
Version #: 1.3 
Date: 11/18/19 
Page 10 
 
12.  Harvey N, Holmes CA. Nominal group technique: An effective method for 
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