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ObesityNCT02400554

Yappalli - The Road to Choctaw Health

A study testing Yappalli in people with Obesity and Substance Abuse, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Substance Abuse
What is being tested?
Yappalli
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteUnited States
Study dates
Mar 2015to 30 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-identify as women
  • Be enrolled in the Choctaw Nation of Oklahoma
  • Reside in the designated county
  • Be 18 years of age or older
  • Have tried any tobacco, alcohol, or drugs OR ever felt out of control with any food in past 5 years
  • Be able to walk unassisted for at least 10 minutes

Who cannot join

  • Women who are actively using opioids (i.e., heroin) methamphetamines and/or abusing prescription drugs not prescribed to them (e.g., Dilaudid, Oxycontin) or alcohol dependent (5+ bottles/glasses of alcohol a day).
  • Women who exhibit serious psychiatric symptoms determined by CNO trained staff.
  • Women who have been suicidal in past 3 months, are currently pregnant, or are denied medical approval.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Choctaw Nation of Oklahoma

    McAlester, Oklahoma, 74501

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Yappalli
Keywords
Indian, North American, Oklahoma, Female, health promotion
Medical subject headings
Obesity, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YappalliBehavioural

    Month 1-3: Up to 8 group sessions on Choctaw history, traditions, cultural systems, \& women's roles. Up to 3 individual Motivational Interviewing (MI) sessions to identify community leadership \& personal change goals on the main outcome.

    Month 2: Overnight Culture Camp to strengthen group cohesion \& synthesize goals.

    Month 3: Walk for a week on the Choctaw Trail of Tears, upon completion make a commitment to conduct a community-wide event based on personal \& leadership goals \& experience on the Trail.

    Months 3-12: Up to 6 group meetings to plan community leadership events related to ATOD \& obesity prevention. Includes: digital storytelling training to create a story related to ATOD \& obesity prevention \& an individual MI booster session to revise their personal \& community leadership goals.

    Month 12: Share digital stories \& community event experiences \& undergo a ceremony to transition to health leaders within their communities.

Study groups in NCT02400554
Study groupRoleWhat they receive
Wait List ControlNo interventionParticipants wait one year before receiving the intervention. Three assessments are taken over this period: Month 3, Month 9, and Month 12.
YappalliExperimentalYappalli: Participants attend a 12-month behavioral intervention.
Receives: Behavioral: Yappalli

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Food Habits as assessed by the Yale Food Addiction Scale

    Yale Food Addiction Scale - continuous measure items

    Measured: Post-Walk (month 3) and Post Intervention (month 12)

  2. Weight Change

    Investigators will assess weight change for each individual

    Measured: Post-Walk (month 3) and Post Intervention (month 12)

  3. Changes in Physical Activity assessed using items from the California Health Interview Survey

    Investigators will assess changes in physical activity and leisure time activity in participants using items from the California Health Interview Survey

    Measured: Post-Walk (month 3) and Post Intervention (month 12)

  4. Change in Alcohol Use as assessed by the Alcohol Use Disorders Identification Test.

    Assess changes in alcohol use (frequency, amount, consequences and context) using the Alcohol Use Disorders Identification Test.

    Measured: Post-Walk (month 3) and Post Intervention (month 12)

  5. Change in Other Substance Use as assessed by the Phen-X toolkit

    Phen-X toolkit for 30-Day Use (for items that are applicable)

    Measured: Post-Walk (month 3) and Post Intervention (month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion30 May 2022
  4. Study completion30 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02400554
Sponsor's protocol ID
STUDY00001641
Other IDs
R01DA037176
Status last verified
Sep 2021
First submitted
17 Mar 2015
Last updated
3 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Yappalli in people with Obesity and Substance Abuse, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Food Habits as assessed by the Yale Food Addiction Scale (time frame: Post-Walk (month 3) and Post Intervention (month 12)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.

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