Yappalli - The Road to Choctaw Health
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02400554|
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : July 2, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
Yappalli: Participants attend a 12-month behavioral intervention.
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.
- 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
- Weight Change [ Time Frame: Post-Walk (month 3) and Post Intervention (month 12) ]Investigators will assess weight change for each individual
- 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
- 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.
- 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)
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
|Contact: Rebeca A Marin, PhDfirstname.lastname@example.org|
|Contact: Cynthia R Pearson, PhD||(206) email@example.com|
|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|