Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02400554 |
| Other study ID # |
STUDY00001641 |
| Secondary ID |
R01DA037176 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2015 |
| Est. completion date |
May 30, 2022 |
Study information
| Verified date |
September 2021 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is an obesity and alcohol, tobacco, and other drug (ATOD) use risk prevention and health
leadership program. This project will include 150 at-risk adult Native women across 5
communities (30 women from each community) in the Choctaw Nation of Oklahoma. The
intervention targets individual behavioral change relative to ATOD and obesity prevention and
simultaneously provides behavioral skills for health promotion leadership.
Investigators will conduct a longitudinal study using a cluster randomized stepped-wedge
design to evaluate the intervention impact on ATOD and obesity prevention primary aims of:
(1) substance use harm reduction and ATOD use and intentions to use; and (2) reduction in
weight/body mass index (BMI) and increase in leisure-time physical activity/physical activity
(LTPA/PA) and healthful food habits. Specifically, investigators will ask participants to
participate in up to eight group sessions (based on a curriculum drawing on cultural
teachings around health and behavioral change); attend up to three Motivational Interviewing
individual sessions (to identify individual behavioral change goals); attend a two-day
overnight culture and Trail prep camp; participate in camping and walking for up to 10 days
on the Trail; and attend up to six post-walk meetings (to develop community health events).
All five communities will also be asked to complete a baseline health assessment as well as
three follow up assessments over the course of the year. Additionally, communities 2-5 will
participate in three pre-intervention health assessments. This intervention integrates
components of motivational interviewing, information-motivation-behavior, and a leadership
development framework for adults. It targets individual behavioral change relative to ATOD
and obesity prevention and simultaneously provides behavioral skills for health promotion
leadership within their respective communities.The project addresses a critical public health
issue among a group experiencing considerable health disparities and strengthens the research
infrastructure in partnership with the Tribe. If efficacious, it has the potential for
widespread dissemination and could be generalizable to other chronic co-occurring mental
health and physical health conditions.
Description:
Study Design:
Investigators will conduct a 5-community longitudinal study using a cluster randomized
stepped-wedge design to evaluate the intervention impact on alcohol, tobacco, and other drug
(ATOD) and obesity prevention primary aims of: (1) substance use harm reduction, overall ATOD
use and intentions to use; and (2) weight/body mass index (BMI) change as well as the effect
on leisure-time physical activity/physical activity (LTPA/PA), and healthful food habits
among adult Choctaw women at risk for obesity and ATOD. The cluster randomized stepped-wedge
design is a type of cross-over study in which clusters of women from each community cross
over to the intervention arm at randomly assigned time points (one time per year, per
community).
Sequence and Timing of Study Procedures:
Randomization: Investigators have created five regional communities and within each community
a convenience sample will be drawn. Each site has been randomly assigned to start the
intervention at a given year. Randomization occurs only to determine the year each community
enters the study. Community 1 will begin the intervention immediately; communities 2-5 will
complete three health assessments prior to beginning the intervention. These will occur at
the same time of post-walk assessments for the community currently in the intervention (i.e.
community 2 does health assessments in the same months community 1 does post-walk assessments
and then begins the intervention in Year 2.)
Recruitment and Screening of Participants:
Recruitment strategies:
- Referrals from staff from Choctaw Nation of Oklahoma (CNO) project staff, staff at
Choctaw Nation Health Services Authority (CNHSA), Community Advisory Council members,
health providers, and general community members. They will provide potential
participants with a flyer and encourage women to call if interested.
- The following strategies will be used as necessary: posting flyers in community health
clinics, stores, community centers, and other locations identified by our community
advisors; and posting flyers in the tribal newspaper, other local news outlets, and on a
study Facebook page.
- Recruitment materials will invite American Indian/Alaska Native women who are interested
in participating in the research study to call a dedicated, toll-free phone number or
the project number at Choctaw Nation.
Screening:
- Participants can opt for a phone or in-person screen using the same script.
- CNO study staff will answer and return phone calls and conduct the screens. Indigenous
Wellness Research Institute (IWRI) staff will conduct eligibility screens on the phone
as needed.
- Women screened out will be given a community resource list. Phone screeners will offer
to mail or email the list.
- If a person is eligible, but declines to participate, they will be given a brief
one-item exit question regarding general reason for non-participation.
- Eligible women who agree to participate will be asked to schedule their baseline
assessment.
Participants will receive reminders by email, text or phone 2 days before, the day before,
and the day of any meetings, assessments, or events.
Consent and Baseline Assessment:
The baseline assessment consists of a brief physical health assessment and a
computer-assisted behavioral health survey administered by study staff. The physical health
assessment is a non-invasive procedure that involves the measurement of BMI (with portable
digital weight scale and height measure) and blood pressure. The computer-assisted behavioral
health survey will ask a series of questions and take under 90 minutes to complete.
After consent is obtained, CNO study staff will set up the study laptop and headphones that
the participant will use to enter their responses to the questionnaire. The variable matrix
includes instructions, prompts, response scales, and references for all measures used for
each behavioral health assessment.
Group Sessions/Yappalli Curriculum (Months 1-3) Participants will attend up to eight group
sessions. The curriculum for these sessions includes: learning about Choctaw history,
traditions,and cultural systems as well as women's roles (e.g., Treaty of Dancing Rabbit
Creek); participating in cultural activities (e.g., stickball or social dances); developing
traditionally-based materials (e.g., walking sticks); and using cultural metaphors for
behavioral changes (e.g., 4 pillars of wellness-mind, body, spirit, emotion)). Experiential,
outdoor activities are incorporated to promote group cohesion, improve relational worldviews,
and connectedness to nature and the environment. Examples include activities on an outdoor
ropes course maintained and managed by CNHSA or increasing LTPA/PA by walking or gardening.
Motivational Interviewing Individual Sessions (Months 1-3) In up to three sessions,
participants will identify personal change goals on the main outcome variables as well as
community leadership goals. These sessions will target four areas: increasing physical
activity or movement; reducing or eliminating "junk" snack foods, sweets, and sugared soft
drinks; decreasing addiction and or potential to misuse tobacco, alcohol or other substances
and food; and increasing community leadership skills.
Culture Camp (Month 2) In this two-day, overnight camp participants will practice camping and
being outdoors (e.g., setting up tents, trying out new shoes and equipment, etc.) and begin
to strengthen group cohesion prior to embarking on the Trail. It is also designed to
synthesize goals and cultural values discussed in the group and individual sessions.
Trail of Tears Walk (Month 3) Participants will gather at a location in Oklahoma before
driving to a starting point at the Mississippi/Arkansas border then follow one of the routes
of the Choctaw Trail of Tears through Arkansas and back into Oklahoma. They will walk on
average 8-10 miles per day and travel by van for a portion of the trail to a different
campsite each day. At the end of the trip, the walkers will have walked approximately 60-80
miles over the 260 mile route. On the last night of the Trail, participants will make a vow
to conduct a community-wide event (based on personal and leadership goals and experience on
the Trail) within nine months. Note: a support van will travel along with walkers so that
they could walk as many minutes or miles they feel comfortable doing (e.g., from 10 mins.
Less than a quarter mile to 10 miles).
Post-Walk assessments (Months 3-12) Three follow-up health assessments will occur: one
immediately post-walk in Month 3, one in Month 9, and one in Month 12. These behavioral
health assessments will be collected in the same manner and include a similar set of measures
as the baseline assessment. The physical health assessments will also be conducted in the
same manner as the baseline assessment.
Post-Walk Group Meetings (Months 3-12) Participants will attend up to six group meetings to
plan community leadership events (investigators provide a small budget for the women to
create a community event such as a community food garden). Specific meetings include: at
three months post-walk a digital storytelling training to create a story related to ATOD and
obesity prevention and their personal experiences; and at six months post-walk an individual
MI booster session to revise their personal vows/goals and community leadership goals.
Final Community Event (Month 12) Participants will share digital stories and/or community
event experiences and undergo a naming ceremony as they transition to health leaders within
their communities. They will be given the option to become a member of one of seven Choctaw
health promotion societies on which the intervention is based to continue their health
promotion leadership efforts after their participation in the project ends.
