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Yappalli - The Road to Choctaw Health

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ClinicalTrials.gov Identifier: NCT02400554
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karina Walters, University of Washington

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Substance Abuse Behavioral: Yappalli Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Yappalli - The Road to Choctaw Health
Actual Study Start Date : March 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
No Intervention: Wait List Control
Participants wait one year before receiving the intervention. Three assessments are taken over this period: Month 3, Month 9, and Month 12.
Experimental: Yappalli
Yappalli: Participants attend a 12-month behavioral intervention.
Behavioral: Yappalli

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.





Primary Outcome Measures :
  1. Change in Food Habits as assessed by the Yale Food Addiction Scale [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]
    Yale Food Addiction Scale - continuous measure items

  2. Weight Change [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]
    Investigators will assess weight change for each individual

  3. Changes in Physical Activity assessed using items from the California Health Interview Survey [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]
    Investigators will assess changes in physical activity and leisure time activity in participants using items from the California Health Interview Survey

  4. Change in Alcohol Use as assessed by the Alcohol Use Disorders Identification Test. [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]
    Assess changes in alcohol use (frequency, amount, consequences and context) using the Alcohol Use Disorders Identification Test.

  5. Change in Other Substance Use as assessed by the Phen-X toolkit [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]
    Phen-X toolkit for 30-Day Use (for items that are applicable)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400554


Contacts
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Contact: Rebeca A Marin, PhD 206-685-4927 rmarin@uw.edu
Contact: Cynthia R Pearson, PhD (206) 330-1997 pearsonc@uw.edu

Locations
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United States, Oklahoma
Choctaw Nation of Oklahoma Recruiting
McAlester, Oklahoma, United States, 74501
Contact: Kristie Brooks, MS, LPC    918-302-0052 ext 30142    klbrooks@cnhsa.com   
Contact: Sandra Stroud    (918) 470-6234    SLStroud@cnhsa.com   
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Karina L Walters, PhD University of Washington
Principal Investigator: Kristie Brooks Choctaw Nation of Oklahoma
Principal Investigator: Michelle Johnson-Jennings, PhD University of Saskatchewan

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Responsible Party: Karina Walters, Associate Dean for Research; William P. and Ruth Gerberding Endowed University Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02400554     History of Changes
Other Study ID Numbers: STUDY00001641
R01DA037176 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karina Walters, University of Washington:
Indian, North American
Oklahoma
Female
health promotion

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders