Collaborative implementation of a community-based exercise intervention with a partnering rural American Indian community.

Abstract

Background:

The prevalence and socioeconomic burden of childhood obesity and diabetes has increased rapidly in the United States in the last 30 years. American Indians have the highest prevalence of type 2 diabetes among newly diagnosed youth in the country. Contributing factors include environmental, behavioral and genetic components. Some American Indian tribal communities have explored innovative ways to combat this epidemic including collaborations with academic centers on community-based research.

Method:

From 2012-2017, The University of Oklahoma Health Science Center and the Choctaw Nation of Oklahoma partnered on a National Institutes of Health funded project to determine if financial incentives would elicit an increase in physical activity in Native youth. This was a community-based behavioral intervention for overweight or obese American Indian youth ages 11-20 living in a rural community at risk for developing diabetes.

Results:

Tribal leaders and staff identified culturally appropriate strategies to aid implementation of the trial in their community. Their identified implementation strategies helped standardized the study in order to maintain study integrity. The mutually agreed strategies included: co-review of the study by tribal and University research review boards (but designation of the Choctaw Nation review board as the “Board of Record”), training of community-based staff on research ethics and literacy, standardization of the informed consent process by videotaping all study information, creation of a viable and culturally appropriate timeline for study implementation, adapting tribal wellness center operations to accommodate youth, and development of effective two-way communication through training sessions, on-site coordination, and bi-monthly conference calls.

Conclusion:

In an effort to partner collectively on a randomized clinical research trial to combat childhood diabetes, tribal leaders and staff implemented strategies that resulted in a culturally appropriate and organized community-based behavioral intervention research project.

Background

Approximately 30% of children and adolescents in the United States are overweight or obese.¹ This trend has contributed to an increased prevalence of cardiovascular and metabolic disorders in youth, including type 2 diabetes, hypertension, and metabolic syndrome.^2-4 It is projected that 53% of minority children born in the year 2000 will develop diabetes within their lifetime.⁵ American Indians are 2 to 3 times more likely to develop diabetes than the non-Hispanic white population.⁶ Factors that contribute to American Indians’ disproportionate rates of diabetes include environment, behavior, and genetic components. When American Indians were relocated to reservations in the late 1800s, tribal people lost access to their traditional foods, medicines and active lifestyles.⁷ Today, many American Indians still live in communities with a high rate of poverty and limited access to healthy foods.⁸

The Choctaw Nation of Oklahoma, a federally recognized tribe in Southeast Oklahoma, provides a variety of healthcare services for over 30,000 American Indians and Alaska Natives annually.⁹ Health status reports published by the Choctaw Nation Health Services in 2010 and 2012 noted that their adult patient population had a higher rate of obesity than the United States population (53% versus 39%, respectively).^9-11 Similarly, within their pediatric population, 25% of their girls and 30% of their boys ages 12-19 years old were obese, remarkably higher than the obesity rate of 16.9% in the overall population of children in the United States.^10,11

In the last 20 years, Choctaw Nation has made substantial efforts to improve the overall health of its people. To address the problems of obesity and diabetes in youth, they established a partnership with the University of Oklahoma Health Sciences Center (OUHSC) to provide onsite specialty clinics staffed by pediatric endocrinologists. They also partnered in several research endeavors, including the National Institutes of Health funded multi-center trial, Treatment Options for Diabetes in Adolescents and Youth (TODAY).¹² This collaboration included, at the invitation of the Choctaw Nation, a designated health research liaison from the university’s section of pediatric diabetes and endocrinology. This designee, a member of Choctaw Nation, was invited to attend tribal and communities events, including health fairs, elders meetings, and youth and cultural events. For over 10 years, she met with tribal leaders, doctors, staff, and community members to discuss advances in diabetes treatment and prevention and the importance of incorporating new developments into tribal programs. In addition to academic partnerships, the Choctaw Nation recently built 12 wellness centers across their healthcare service area, which impacted the capacity to conduct research within the tribal community. This initiative aimed to provide access to fitness equipment, group exercise classes, and other lifestyle programs at no cost to American Indians living within the Choctaw Nation community.

In 2012, OUHSC and the Choctaw Nation embarked on a new project, funded by the National Institute of Minority Health and Health Disparities, designed to increase physical activity behavior in obese youth ages 11-20 years, at-risk for developing diabetes.¹³ The Choctaw Nation had successfully used incentive-based programs in the past to encourage adults and tribal employees to increase physical activity but had not yet used an incentive-based program with their youth. The primary objective of this collaborative randomized clinical trial, recently published,¹³ was to test whether financial incentives would promote an increase in exercise frequency and/or duration among youth at Choctaw-operated wellness centers.¹³ The primary finding was that financial incentives promoted an increase exercise session duration but did not result in more frequent exercise participation. Additional details with regard to study design and outcomes are available elsewhere.¹³

The study’s grant application was developed with collaborative input and approval from the Choctaw Nation leaders, community members, health service, and wellness center staff with specific research agreements related to data and resource sharing.^13-15 Following funding and initial implementation of the study, scheduled and frequent collaborative discussions continued, to ensure that the study remained culturally appropriate and scientific integrity was maintained. OUHSC’s previous clinical trials with American Indian communities in Oklahoma required that most clinical tests and data collection be conducted on the OUHSC Oklahoma City campus.^12,16,17 This study; however, was designed so that all clinical tests, exercise activities and data collection be conducted within the Choctaw Nation’s community, approximately 200 miles from the university campus.¹³

Several prior reports outline steps for conducting community-driven research with tribal nations and most emphasize the importance of building trust and research capacity.^12,14,15,18 However, few reports illustrate the enhancements that are made during a randomized clinical trial’s implementation when a community’s insight, solutions, and resources are utilized.¹⁸ One principal aim of this paper, written in partnership with representatives from the Choctaw Nation, is to illustrate how culturally appropriate strategies can aid in the implementation of a community-based randomized clinical trial while preserving the overall scientific integrity of the study. The implementation strategies include the designation of the Choctaw Nation Institutional Review Board (IRB) as the primary IRB, train staff on the principals of human subjects ethical research, illustrate the study through video in order to provide a consistent and systematic consent process, and use frequent and collaborative communication methods among the researchers, leaders, and research staff.

Methods

Study overview

The primary goal of this randomized clinical trial was to test whether financial incentives would increase the frequency and duration of physical activity performed by overweight/obese adolescents.¹³ The secondary objective was to gauge the impact of exercise on clinical measures related to health and fitness. Seventy-seven adolescents were enrolled and completed exercise at four different wellness centers operated by Choctaw Nation. Thirteen Choctaw Nation Wellness Centers were available for use during the study.¹³ Male and female American Indian youth 11-20 years old were recruited from the Choctaw Health Service patient population and community referrals, including schools, family members, advertisements, and tribal events throughout southeast Oklahoma.¹³

The study designed using the Incentive Theory of Motivation principles and included 3 randomized treatment phases, 16 weeks each, in which the participants were incentivized for completing exercise sessions.^13,19 Each phase had two incentive groups (control and an increasing incentive group) and each groups’ exercise behavior (number of exercise sessions, duration of sessions and maintenance of behavior) was collected. Depending on the randomized group, the participants received monetary incentives for completing exercise sessions. Earned monetary incentives, as low as $4 or as high as $16 depending on the study phase and randomized enrollment, were loaded bi-weekly to a reloadable debit card issued to the participants.¹³ All study procedures, exams, exercise sessions, payment process were conducted by the Choctaw Nation staff. More detailed information related to the study design and outcomes is published elsewhere.¹³

Pre-implementation meetings and members

Before study implementation, OUHSC investigators and the Choctaw Nation’s tribal leaders met to determine how the study would be implemented into the community. These planning meetings were designed using community-based research principles. Members included the OUHSC team which was comprised of the study’s co-principal investigators, who were not American Indian, and a research tribal liaison, an enrolled member of the Choctaw Nation of Oklahoma. Also, representatives from the Choctaw Nation attended the implementation planning meeting including tribal leaders, tribal health services authority director, tribal research board chairman, director of preventive health, medical clinic director, director of the wellness centers and clinic and diabetes wellness center staff members. The tribal leaders identified the communities within the Choctaw Nation they viewed to be best suited for the clinical study, both by personnel and location. Pre-implementation meetings were conducted over the first 8 months of the funding period and proved beneficial in establishing open and frank communication among all study personnel. These meetings identified culturally appropriate strategies that aided in a smoother implementation process (Figure 1).

Figure 1.

Addressing identified strategies for implementing a community-based clinical research trial and numerous mechanisms used to assessed and monitored study standardization and integrity throughout the trial’s duration.

Results

Review board of record

The study had two Institutional Review Boards (IRB): the Choctaw Nation and the University of Oklahoma. When a study falls under the purview of two or more IRBs, to reduce the duplication of effort and eliminate confusion, one IRB can be designated as the “Board of Record”.²⁰ The Choctaw Nation of Oklahoma, a sovereign nation, has a federally-recognized IRB and require their IRB to approve all studies conducted within their nation.²¹ The OUHSC IRB recognizes the federally approval status of the Choctaw Nation IRB but generally requires the University of Oklahoma Health Sciences Center board to serve as the Board of Record for projects initiated by university employees, particularly when the university is the primary grant recipient.²⁰ However, since all of the study participants were Choctaw Nation Health Service patients, and the primary data collection, record storage and intervention activities were conducted at Choctaw clinics and wellness centers, we argued successfully that the Choctaw Nation should be designated the Board of Record. Following this designation, the Choctaw Nation IRB had authority to make the first decision on the study protocol and subsequent revisions, followed by an OUHSC IRB review. Throughout the project, the investigators completed annual continuing review processes with both IRBs and filed notifications to each IRB about all communications. This arrangement worked smoothly for both IRBs.

Training on research ethics and literacy

Choctaw Nation employees were qualified to work with patients within their medical and community settings, but few had prior experience with research protocols. Many Choctaw Nation employees, including clinic and wellness center staff, were needed to effectively recruit, enroll, and collect study data. To conduct the randomized clinical trial appropriately, the tribal leadership recognized it was necessary to train their employees on the importance of research ethics and protocol.

To meet this need, Choctaw Nation IRB provided ethical guidance to study personnel and required key study personnel to complete the online human subjects research training provided by the Collaborative Institutional Training Initiative. Before study enrollment begun, the Choctaw Nation IRB and university investigators held a one-day educational research seminar for all study staff. Topics discussed included the importance of IRBs, how research differs from clinical care, and specific ethical requirements for conducting research (Table 1). The study staff was informed about the importance of research oversight, research terminology, secure record keeping, and privacy policies. It concluded by encouraging the tribe’s community staff members to share their suggestions regarding study implementation. The ensuing discussion identified the need for a simplified standardized consenting process, methods to secure the privacy of study participants and the research data, feasible procedures to collecting biomedical samples from several locations, an easy to follow procedural checklist, and a clear understanding of the coordinated research oversight procedures.

Table 1.

Topics covered during the "Introduction to Research" training session.

What is an IRB?	Understand Differences	Protections for Participants	Strategic Planning
History of Research and Mistrust Importance of Ethical Oversight	Between Clinical Care and Research Protocol Adherence	Informed Consent Data Integrity Reporting Adverse Events Health Information Privacy	Roles and Job Duties Potential Barriers and Solutions

Videotaping study information to standardize consent

Tribal employees noted that the study had a complex biomedical behavioral modification research design and that multiple study personnel in different locations would be required to complete the consent process. To assure that the study was explained in a consistent way to each participant and their family, they recommended using a video to explain the study’s aims and to demonstrate some of the study procedures. The Choctaw Nation IRB director was aware of other studies using multimedia tools during the informed consent process,^22,23 however, that approach had not previously been used by Choctaw Nation or the study team. The Choctaw Nation IRB requested the video be limited to nine minutes in length, so that participants would not lose interest and miss important information. We filmed the start of the video at a tribal community center, where we introduced the investigators and provided a brief history of the university and tribal partnership. Next, we explained the study’s purpose, design and procedures (Table 2). The video was approved by both IRBs prior to use. After participants watched the video, the study coordinators completed the consenting process with the participants and their parents/legal guardians by answering questions and completing the required documentation. The video provided a standard consenting process and gave an opportunity for the university study team members to collectively introduce themselves to the participants and their families. The study staff reported the video worked well and was well received by the participants and their families.

Table 2.

Key elements included in the video description of the MOVE Study and approximate time spent addressing each item. This informational video was shown before attaining consent from the adolescents and their parents or guardians.

Topics covered on the study description video	Approximate Time
Introduce the MOVE Study and explain the research partnership	1 minute
Introduce study investigators, staff and display facilities	1 minute
Explain study protocol and procedures	4 minutes
Demonstrate the study equipment	2 minutes
Describe how to enroll in the study	1 minute
Total Length of Video	9 minutes

One center during the first year

Choctaw Nation had seven wellness centers operating at the onset of the study; however, it was not feasible to begin enrollment at every location because of distances between them (approximately 60 to 200 miles) and the large staff required to coordinate such an effort. At the recommendation of tribal leaders, the study began at one wellness center and clinic in Hugo, Oklahoma. In the first 8 months of active enrollment, 14 participants entered the study, which allowed the study team to make refinements in procedures, organization, and communication methods. After operating for a year at the first location, study operations were sequentially extended to other locations. Study enrollment increased rapidly thereafter, reaching 90 overweight/obese adolescents in the exercise intervention arm of the study (77 of whom qualified, completed baseline testing, and began the exercise program) and 52 in a normal weight reference group (39 of whom qualified and completed baseline testing; this group did not enter the exercise program) by the conclusion of the study.¹³

Adapting wellness centers for youth

During the pre-implementation discussions, Tribal leaders noted that many of their wellness centers did not have youth-tailored services. The majority of those who used their wellness centers were adults, with most centers restricting use by children under the age of 14. Since the study plan was to enroll children as young as 11 years old, tribal leaders adjusted the age policy so that all study participants could access the wellness centers.¹³ The centers also modified hours of operations, encouraged family members and friends to exercise with the study participants, and allowed more flexible access (i.e., when wellness staff were not present, children in the study could use the facilities as long as they were accompanied by a parent/guardian). Other modifications included offering after-school fitness classes and/or designating staff members to work specifically with the youth. These changes provided the younger participants (11-13 years old) exposure to fitness classes, equipment, and health education that would not have been yet available to them otherwise.

Provision of clothes and gear for exercise

Tribal leaders also recommended providing participants with appropriate exercise clothes, shoes, and workout gear. They noted that often people using their exercise facilities lacked the proper athletic gear needed to exercise safely and comfortably. Thus, in addition to the financial incentives for exercise behavior, all enrolled participants received a shirt, water bottle, socks, and bag imprinted with the study logo (The MOVE Study) and the Choctaw Nation’s seal. In addition, after participants completed their fourth exercise session, thus demonstrating their preliminary commitment, they were provided with up to $250 in credit towards the purchase of athletic clothing from an online vendor. These workout supplies were given to all eligible participants so as not to interfere with the primary financial incentive structure.

Unified communication and coordination efforts

To coordinate and maintain the scientific integrity of the randomized clinical trial the stakeholders felt it imperative to find ways to unify study communication. The partners agreed to three primary study coordinators, designated by Choctaw Nation, who would be responsible for data collection and communication with study participants and their families. Throughout the study, the coordinators monitored exercise records, scheduled testing sessions, and helped families to identify and remove barriers that might interfere with the participants’ ability to meet their exercise goals. The study coordinators were the central points of contact for all parties: study investigator, youth, parents, staff and clinical support. A nurse with more than 10 years of experience in facilitating clinical trials for Choctaw Nation was designated as the primary study coordinator. She organized and supervised all coordination efforts including identifying potential challenges to study execution and problem solutions.

Participants could perform exercise sessions on their own schedule and select any type of exercise activity available, including culturally appropriate activities. Thus, all staff members at the wellness centers needed to understand the study, goals, and procedures. The study coordinators trained the wellness center staff on how to operate the research equipment (e.g., heart rate monitors, accelerometers) and how to respond to basic study questions regarding exercise goals.¹³ Also, they instructed the center staff on how to use a procedural and information manual in case they had questions. This was an important aspect of study implementation because any miscommunication could have affected the participants’ physical activity behavior.

Since the study team was located at numerous sites, it was essential to maintain frequent and open communication. To assure that all study personnel stayed informed about study progress, bi-monthly teleconference meetings were held. With Choctaw Nation’s support, members of the research office, IRB, clinics or other tribal departments participated in the meetings throughout the duration of the study. These meetings addressed administrative tasks, continuous procedural maintenance, recruitment and retention of participants, and standardization of the intervention delivery. Most minor details were handled through e-mail among study members, but the teleconference meetings provided an avenue to openly discuss and collectively resolve concerns that arose during the study.

The university investigators also made frequent visits to the tribal wellness centers to verify that study procedures were accurately followed and provided additional support when needed. During site visits, the investigators assisted with participant enrollment and testing, conducted chart reviews, met participants and their families, inspected and repaired equipment, and reviewed study procedures with study coordinators and staff. When problems were identified, the investigators made every effort to ensure that the study coordinators and staff felt supported and that investigator visits were not interpreted as punitive but as opportunities to identify tasks that might be challenging and/or concerning for the sites. The Choctaw Nation encouraged these visits and viewed them as a method for coordinators to feel more confident in executing the study.

Discussion

Our experience was that open and frequent communication methods were important in organizing and facilitating the implementation of a randomized clinical trial within a community. The early collaborative discussions with key personnel, including investigators, tribal leaders, health care officials and community members, developed a foundation for the project and was used to identify important details to addressed during study implementation. It was during these discussions that the study partners established culturally appropriate solutions to study implementation, including designating the tribal IRB as the IRB of record, the use of local and accessible wellness centers, and a feasible timeline to conduct and complete the study considering community needs. All discussions were designed to be open and collaborative, so that tribal employees felt comfortable discussing ideas and concerns regarding the facilitation of the study, especially those who did not have prior clinical research training and might have felt intimidated. The conversations held at the outset of the project led to the development of an operational manual, a tribal administrated research and ethics training seminar, a video presentation highlighting the research partnership and consent, all of which helped to define and organize personnel roles and responsibilities. Continuous discussions among the research partners were held throughout to assure that study scientific goals were met and that the study was implemented appropriately for the community it was designed to serve.

Some of the pre-implementation suggestions, however, were not successfully met. For example, we collectively agreed that all participants would receive basic nutritional education to encourage a healthier lifestyle. However, during implementation, Choctaw Nation recognized that they did not have enough nutrition staff and/or nutrition classes to provide consistent, high-quality nutrition education to all participants especially at times that best fit with the participants’ school schedules. Proposed suggestions to address this issue included utilizing additional diabetes educators and developing a nutrition video, but ultimately due to travel barriers and limited personnel, these solutions were not possible. Since the dietary educational component was not critical to the overall study goal of increasing physical activity behavior, we removed this component soon after study enrollment began. Healthy eating remains an important goal for Choctaw Nation and for future projects we intend to address these barriers earlier in order to assure participants are provided basic dietary education.

Another pre-implementation suggestion was to provide transportation assistance for youth to get to the wellness centers. The study was conducted in rural settings with wellness centers located in small towns and car travel to the wellness centers was necessary for most participants. The majority (77%) of participants were less than 16 years old and were therefore not legally able to drive themselves.¹³ Tribal leaders tried to remedy this by extending the operating hours of the wellness centers (to allow more time for participants to arrange transportation) and/or referring families to transportation support services available in their communities. However, due to various unforeseen issues including work schedules, school activities and/or unexpected family life events, some participants still reported transportation as a barrier to meeting their exercise goals. This has prompted us to consider home-based physical activities for our future projects.

In addition to nutrition education and transportation barriers, tribal leaders noted many of their youth experience personal challenges including conflicting school/social activities, family responsibilities, parent’s employment, family crisis and weather-related issues. Choctaw Nation suggested referring families to social service programs available to tribal members; these included afterschool programs, career development, tutoring, youth outreach, housing, and energy assistance. When a referral need was identified, study staff referred the participants/family members to the appropriate social service program; however, the number of referrals and whether the services were utilized was not tracked so it is unknown how many referring participants/families found these programs helpful. We believe the challenges we experienced in trying to meet these suggested refinements were not the result of a poor study design, uninformed planning or affected the study’s integrity, but represent common challenges inherent to most community-implemented behavior modification studies.

In the current project, the availability and incorporation of tribal resources like the wellness centers, clinics, and research staff, were critical for meeting enrollment goals and successful completion of the trial. Conducting a similar trial in a rural community without the structural support of the tribe and the many people who contributed to this project might still be possible, but certainly would be more difficult. We believe when a randomized clinical trial remains flexible to the community's needs and suggestions it can improve the implementation process without affecting the scientific integrity of the trial.

In moving forward, the OUHSC Pediatric Endocrinology Section will continue to provide clinical services to the Choctaw Nation of Oklahoma while addressing the Nation’s research interests and goals. We are actively working together to increased physical activity in American Indian youth by testing new incentive-based techniques. OUHSC and the Choctaw Nation intend to continue their collaboration by using the information gained through research, including this study, to improve upon the health of the American Indian youth.

Summary

With the Choctaw Nation’s direction and guidance, a community-driven randomized clinical trial was designed to address a burgeoning public health problem in American Indian youth in southeastern Oklahoma. Through early, frequent and open conversations between research partners, culturally appropriate implementation strategies were identified and implemented effectively. These strategies included the designation of the tribal IRB as the lead board to conduct ethical oversight of the study, and culturally designed ethical research training for staff. The tribal nation identified study needs, defined staff members’ roles, determine community involvement and helped define the timeline for effective study implementation. Following the principles of community-based research and utilizing open communication and community guidance to identify barriers and solutions, a tribal-directed randomized clinical trial was effectively implemented within a rural tribal area.

Abbreviations:

OUHSC

University of Oklahoma Health Science Center

IRB

Institutional Review Board