Original study protocol
The D.C. COOKS with Heart is a part of a long-term CBPR study to design culturally specific, community-based interventions to address cardiovascular risk factors, such as obesity. A community advisory board, the D.C. Cardiovascular Health and Obesity Collaborative (D.C. CHOC), was established in 2012 and is made up of a multidisciplinary research group, a university faculty in nutrition and community health, and church leaders from predominantly African-American, faith-based organizations in Washington, D.C. areas with the highest CVD prevalence and where access to physical activity resources and health nutrition is limited [10]. The Washington D.C. Cardiovascular Health and Needs Assessment (NCT 01927783) was the first research study designed by D.C. CHOC [11]. One of the overarching goals of the study was to assess potential psychosocial and environmental barriers to behavior change concerning physical activity and a healthy diet. Specific details of The Washington D.C. Cardiovascular Health and Needs Assessment can be found in prior publications from our group [11,12,13].
D.C. COOKS is a two-phase mixed-methods behavioral study designed to assess the acceptability and feasibility of a cooking behavior intervention among African-American adults that are at risk for CVD. A detailed description for both Phase 1 and Phase 2 of D.C. COOKS, including inclusion and exclusion criteria, is available in a previously published protocol paper [14]. Phase 1 includes the assessment of the acceptability of the intervention for the study population through focus groups and was adapted during the COVID- 19 pandemic. Phase 1 was thus designed to elicit findings from surveys (quantitative) and focus group discussions (qualitative) to identify potential barriers and facilitators to cooking behavior in the study population, as well as to inform the design of phase 2 [14].
In Phase 1, eligible study participants (n = 20) were to participate in one of the two moderated focus group sessions, held at a convenient community site. Focus groups were planned to have a moderator, co-moderators, and two note-takers present to record comments, as well as non- verbal observations. The focus group participants were to take electronic self-administered survey measures at the community site using research study tablets. The survey items used included questions related to cooking behavior, non-dietary health behaviors, and psychosocial factors [14].
Phase 2 of D.C. COOKS aims to determine the feasibility of a cooking intervention, especially in association with facilitators and barriers to cooking. It will also aim to explore the relationship between feasibility measures with intrapersonal, social, and built environment factors, dietary quality, and CVD biomarkers and anthropometric measures. Biomarker and anthropometric measurements are to be collected at baseline and follow-up clinic visits at the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. Currently, in-person, virtual, or hybrid adaptations to Phase 2 are being considered due to the ongoing pandemic.
The original study protocol was approved by the (NIH) Intramural Institutional Review Board (IRB) in February 2020. After IRB approval, phase 1 was planned to start recruitment for focus groups utilizing a participant registry from The Washington D.C. Cardiovascular Health and Needs Assessment (NCT01927783) and from the DC CHOC sites. Using a purposive sampling approach, study staff were to contact and screen the potential participants based on eligibility criteria (African-Americans, age > 18, residents of ward 7 or 8, and self-reported risk of cardiovascular disease), with aims to recruit a diverse demographic group. The study procedures adhered to current Consolidated Standards of Reporting Trials (CONSORT) guidelines. Recruitment activities were planned, but was postponed due COVID-19 pandemic in March 2020.
Study population and community engagement
The study population for D.C. COOKS consists of African-American adults (age ≥ 18) who reside within one of two neighborhoods (wards) in Washington, D.C.: Ward 7 or 8. Among the Washington DC population, these communities have the highest prevalence of CVD related risk factors and as defined by the United State Department of Agriculture are under-resourced in terms of accessibility to grocery stores/fresh food [15]. Home cooking frequency, a dietary behavior representing food and consumer choice, is positively associated with diet quality [16]. However, African-Americans, a population with a disproportionate burden of diet related disease, report less frequent home cooking on average compared to other racial/ethnic populations [16, 17]. Although cooking intervention studies in the African-American population show improvement in self-reported scores, home based cooking interventions may be required for sustainable behavior modification as participants acquire the knowledge and skills within the intervention related to nutrition education and that translates into dietary quality improvement [14]. As a result of the under-resourced food environments within Wards 7 and 8, these neighborhoods were selected for the D.C. COOKS study as the sites for intervention.
COVID-19 pandemic restrictions and implications for D.C. COOKS
Wards 7 and 8 present significant economic and health disparities as compared to the rest of the city [1]. These neighborhoods, which represent the majority of the African-American population in the city [18], were impacted disproportionately by the pandemic, with higher mortality rates from COVID than other areas of the city. For instance, during the first year (2020-2021) of the pandemic African-Americans made up only 46% of the population in Washington, D.C. but consisted of 77% of the deaths from coronavirus in the city (https://coronavirus.dc.gov/data). In concert with CBPR principles of understanding ongoing and temporal concerns of a community, it was important that the study be made virtual not only to serve the needs of the research institution but also to protect and provide a safe, contactless experience for the study participants, whose daily lives were severely impacted by the COVID-19 pandemic. As a result of the challenges from the COVID-19 pandemic and the effects of the pandemic on the study community, the research team decided to make adaptations to the original protocol that would be required to provide virtual administration of the study procedures from Phase 1. Modification of the protocol included changes to the informed consent process, administration of electronic surveys, changes in the format of the focus groups, and to the focus group moderator guide. The changes to the protocol are discussed in the sections below including pertinent institutional roles, collaborations, and technology-based adaptations.
A tenet of CBPR is to establish long-term relationships with community members and leaders through multiple points of engagement. Following this tenet, participants in our prior CBPR study and members of the D.C. CHOC received updates quarterly on ongoing study activities through the distribution of a newsletter and CAB meetings. The D.C. CHOC coordinator and research team members also participated in community activities. During the COVID-19 pandemic, these community activities included virtual events. In August 2020 a presentation was made by one of the study investigators, who served on the Medical Executive Committee of the NIH CC, to the D.C. CHOC community board regarding the continuation of patient care and research through NIH policy modifications. In addition, the study PI provided an update to the D.C. CHOC on the plans to adapt Phase 1 of the study to virtual setting.
Institutional role in adaptation
The research institution for D.C. COOKS is the National Institutes of Health Clinical Center. A single intramural Institutional Review Board serves the NIH Clinical Center for oversight of research conduct and human subject protections. An amendment was submitted to the NIH Intramural IRB in December 2020 to conduct the Phase 1 study protocol focus groups virtually. The amendment was approved by the IRB without stipulations in February 2021. The recruitment of participants started in February 2021. Virtual focus groups occurred between March to April 2021.
In addition to the IRB, departments within the NIH Clinical Center coordinated and collaborated with stakeholders from respective research study teams in implementing study procedures that align with federal policies regarding privacy and confidentiality. As a response to the COVID-19 pandemic, a majority of elective, non-acute, in-person visits shifted to telehealth visits for clinical research participants at the NIH Clinical Center. To ensure continuity of research and patient care activities, a telehealth policy was approved and implemented in April 2020. The telehealth platform approved was similar to a virtual teleconferencing platform. The approved telehealth platform was required to have enhanced security and privacy to meet the requirements of the NIH and had to meet protections to ensure Privacy Act compliance. The approved platform for our institution was Microsoft Teams, which was used to conduct the focus groups. A requirement by the NIH telehealth policy requirement was placing a telehealth appointment visit order (similar to placing an outpatient clinic visit order per NIH policy) in the patient’s electronic medical record. This step also prompts the NIH CC’s Telehealth support team to contact research participants to ensure that they have the appropriate device as well as provide the necessary technical support to complete the telehealth visit. The implementation of the platform led to a need for additional training and educational webinars for the research team. NIH Clinical Center Health Information Management Department provided the necessary training for us to successfully complete telehealth visits.
Prior to the COVID pandemic, the NIH Clinical Center Health Information Management Department initiated a pilot program of an electronic signature capture platform for signing informed consent forms. This platform can also be used to obtain informed consent signatures remotely and securely through a link sent through a text (SMS) or email. Our study team participated in the pilot program when the decision was made to transition the first phase of DC-COOKS to an approved telehealth virtual setting. The informed consent process obtained remotely was required to meet the same regulatory and policy requirements as an in-person consent process. The remote consent process reflected an in-person encounter as closely as possible. This included allowing for a real-time, verbal exchange of information between the consenting investigator and the participant to ensure the participant’s understanding of the research. Research staff who were allowed to obtain informed consent, as per the study protocol, underwent a one-hour training provided by the NIH Clinical Center Health Information Management Department on how to use the platform. The training was provided virtually and included synchronous training for available research team members, as well as asynchronous training for team members who could not attend.
Technological adaptations: platform adjustments and testing
A perceived disadvantage of conducting qualitative research through a virtual setting is the loss of in-person non-verbal communication observations due to the limited face only view within virtual platforms. Due to pandemic restrictions, in-person options were not available with the study participants. Therefore, the research team sought to identify ways that in-person setting could be maintained between the moderator and co-moderator. The research team tested a technology platform that could potentially present the moderators and co-moderators of the focus group to be in the same room as in a traditional in-person setting. The platform was the Microsoft Surface Hub (50″ screen size). During the platform testing, the screen size was advantageous in clearly seeing all 4 participants in the perspective of the moderator and co- moderator compared to a laptop or traditional computer screen. However, there were significant barriers identified during the testing phase which precluded the use of this technology. One, an NIH Clinical Center requirement during the pandemic was if more than one person was in the same room, both individuals will have to wear a mask as well as maintain a distance of 6 ft. from each other. The social distancing requirement placed an additional need for a member of the research team to be able to pan and zoom (in or out) the camera between the moderator and co-moderator, which the platform’s compatible camera did not have the functionality. Without that functionality, it could present a difficulty for our research participants to focus on the moderator and co- moderator when they’re speaking. Two, having the moderator and co-moderators wear a mask during the virtual focus group could be considered a barrier in a focus group setting in where non-verbal cues like facial expressions can come into play. Three, verbal sound quality, with a mask over the speaker’s mouth, was compromised and could be a contributor to miscommunication. The research team concluded that using the traditional personal laptop or personal computer in their home office was the best method as all the research team member as well as the moderator and co-moderator would be able to attend without a mask and have the best view of their faces during the focus group.
To follow institutional security requirements, REDCap (Research Electronic Data Capture) housed in the NIH Clinical Center Biomedical Translational Research Information System (BTRIS) server was selected as a secure, web-based application for data collection of the electronic surveys [19].
In previous studies with the study population, smartphones were identified as the device of choice by participants when participating in studies that utilized electronic delivery of surveys [20]. Therefore, the current research team tested the interface of the REDCap survey on smartphones, as well as tablets, to simulate the participant experience. The display of questions and answer choices in smartphones was noted to be not user friendly due to difficulty viewing questions and all answer choices for a question. As display issues may increase participant burden due to difficulty in viewing survey questions, and potentially complicate data collection, tablets were therefore purchased and mailed to each of the 20 participants to use for the survey as well as to attend the virtual focus groups. A basic tablet stand was also provided to participants for participant comfort as each focus group lasted 2 h.
The research team selected an Android tablet that has a minimum screen size of 10 in. Based on pilot testing of the surveys as well as planning for the virtual focus group, a 10-in. tablet will provide the participants the best experience for survey completion as well as for the focus groups. Android tablets were selected because there is a wider selection of cost-effective 10-in. Android tablets in the market. Participants were encouraged to use the tablets to complete the online surveys and for the virtual focus groups.
Informed consent process
Once a participant was screened and deemed eligible to participate in Phase 1, a packet including a copy of the informed consent containing the description of the study purpose and risks were mailed to the participant in advance of a scheduled phone appointment to review and obtain the informed consent (Fig. 1). During the scheduled consent phone appointment, the consenting investigator verified the participant’s name and date of birth, reviewed the consent in detail and the research participant provided verbal confirmation of understanding key elements of the study, as well as risks and benefits. The participant was then provided a secure link either by email or a SMS message to provide their electronic signature. The electronic signature capture was done synchronously in which an investigator obtaining informed consent was remotely present (via telehealth or telephone) while the participant was registering their signature electronically using the platform. After obtaining the electronic signature, the signed informed consent forms were securely transmitted and electronically archived into the research participant’s NIH Clinical Center medical record. A study team member mailed participants a copy of their signed informed consent forms. Utilization of the electronic consent was offered to all eligible participants and accepted by all participants except two. The benefit of the electronic platform avoided the delays and risks (loss) of mailing paper informed consent forms to and from research participants. The platform additionally minimized the need for participants to leave their home, which during the time of pandemic, helped to ensure participant safety. In terms of participant burden, despite admitting that they are technologically challenged, the majority of participants reported to research team members that the electronic informed consent process was easy to use especially when live assistance was available throughout the process.
Quantitative data collection
Consented participants were mailed a paper copy of all survey questions to use during the focus group as a reference during the focus group discussions about survey questions. The online survey was “pinned” on the home screen of the study tablets provided. As a backup, the cover page contained the QR code and the website link that they can use to initiate and complete the surveys. The cover page also contained the participants’ study ID number to be used/entered for the surveys. Participants were asked to complete all survey questions prior to their scheduled focus group.
Advantages of changing to an electronically delivered survey included the ability for participants to take the survey based on their own schedule and time availability, as opposed to just prior to the focus group as planned when Phase 1 was planned in person. Disadvantages of the electronically delivered survey included the additional team resource to provide and mail a paper copy of the survey to participants, the time from the research team to assist participants with technical issues related survey administration (restarting/resuming surveys) on the provided tablet, and ensuring that participants completed the survey prior to the start of their scheduled focus group.
Qualitative data collection
The initial in-person focus groups were planned to divide the study sample into two focus groups using a single moderator with each group consisting of 10 participants (total n = 20). As noted in the literature [5], virtual focus groups, ideally, call for a lower number of participants. An ideal number per group is 3-5 participants. We chose to have 4 participants in each focus group to maintain the total sample of 20. The principal reason for the lower number is to minimize difficulties that may arise with conducting a virtual focus group discussion with a larger number of participants.
All focus groups were scheduled to occur using the approved telehealth platform. The telehealth platform app was downloaded into the tablet prior to mailing it to participants. Participants were sent a secure email invitation from the study coordinator with the telehealth platform invite link to join their respectively scheduled focus groups. In addition to the NIH CC’s Telehealth support team contact, a research staff member also contacted the enrolled participants to provide additional technical support as needed. The frequency of phone call contacts for technical support ranged from one to four phone calls per participant. Depending on the participants’ skill level, the technical support time provided ranged from 5 min to approximately 1 h. The technical support included signing up for a Google account, tablet setup, assistance locating the focus group invite, connecting to Wi-Fi, downloading an email app, and reinforcing instructions on how to use the telehealth platform.