Yappalli - The Road to Choctaw Health

NCT02400554 | Completed DMC

• 2 other identifiers: STUDY00001641R01DA037176
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Substance Abuse

Keywords

Indian, North American; Oklahoma; Female; health promotion

Outcome Measures

Primary Outcomes (5)

• Change in Food Habits as assessed by the Yale Food Addiction Scale

  Yale Food Addiction Scale - continuous measure items

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

• Weight Change

  Investigators will assess weight change for each individual

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

• 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

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

• 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.

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

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

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

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

Study Arms (2)

Wait List Control

NO INTERVENTION

Participants wait one year before receiving the intervention. Three assessments are taken over this period: Month 3, Month 9, and Month 12.

Yappalli

EXPERIMENTAL

Yappalli: Participants attend a 12-month behavioral intervention.

Behavioral: Yappalli

Interventions

Yappalli BEHAVIORAL

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.

Yappalli

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Choctaw Nation of Oklahoma

McAlester, Oklahoma, 74501, United States

Location

MeSH Terms

Conditions

Obesity; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karina L Walters, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Kristie Brooks

  Choctaw Nation of Oklahoma

  PRINCIPAL INVESTIGATOR

• Michelle Johnson-Jennings, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Research; William P. and Ruth Gerberding Endowed University Professor

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)