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Wakaya: Rising Up for Choctaw Youth Health (Wakaya)

Primary Purpose

Obesity, Adolescent, Healthy Nutrition, Sedentary Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wakaya: Rising Up for Choctaw Youth Curriculum
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Adolescent focused on measuring Native Americans, Youth, Oklahoma, Adolescents, Obesity prevention

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be enrolled in Choctaw Nation of Oklahoma (CNO) Be enrolled in High School Live within CNO tribal region for 12 months YES to one of the following: Consumed sweetened beverages or processed/fast food 2x or more per week; OR Engaged in excessive sitting or lying around (>540 min/day) or engage in small screen recreation (>2 hours/day); OR Physical activity - spend <60 minutes/day outdoors or <2.5 hrs per week in moderate or vigorous physical activity OR spend <60 minutes a day in moderate or vigorous intensity aerobic activity; OR Engage in any T.V., small screen/video game recreation (> 2 hours/day) Exclusion Criteria: opioid/methamphetamine drug use (2 times or more in past month) allergic reactions to food (e.g. peanuts), plant (poison oak or ivy) or insects (e.g. bees, fire ants) that caused difficulty in breathing or necessitated hospitalization or caused an anaphylactic reaction disability that prevents student from walking or from engaging in exercise aggressive, violent, combative or inappropriate behaviors inability to follow directions psychotic symptoms

Sites / Locations

  • Choctaw Nation of OklahomaRecruiting
  • University of Washington, IWRI, School of Social WorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Wait List Control

Wakaya (Immediate Group)

Arm Description

Participants in the Wait List group will be randomly assigned to start the intervention 3 months later in the Summer.

Participants in the immediate group will be randomly assigned to start the intervention immediately in the Spring.

Outcomes

Primary Outcome Measures

Change in physical activity assessed by self-report
Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ) for youth and young adults. Results can be reported in categories (low, moderate or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Change in physical activity intensity associated with movement, measured by accelerometer
An actigraph accelerometer measures vertical acceleration in counts per minute. It will be worn for 7 days. Mean counts per minute are calculated by dividing the sum of activity counts for a valid day be the number of minutes of wear time in a day for all valid days. Greater number of counts per minute indicates higher physical activity intensity. Change in mean counts per minute from baseline at 9 months will be assessed.
Change in sedentary behaviors over time
Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth
Change in food and beverage habits over time
Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.
Change in beverage habits over time
Assessed by the Modified Healthy Home Survey (2005- Beverages). It assesses the number of sweetened drinks consumed per week.

Secondary Outcome Measures

Body Mass Index (BMI) change
Mean or percentage change in BMI from baseline. Weight (kg) and height (meters) will be combined to report BMI as kg/m^2.
Weight change assessed via digital scale
Mean weight change (kg)
Change in food addiction
The Yale Food Addiction Scale is a validated measure that has been developed to identify those who are most likely to be exhibiting markers of substance dependence with the consumption of high fat/high sugar foods. Food addiction (dichotomous) can be "diagnosed" when three symptoms and clinically significant impairment or distress are present. Continuous version of the scale ranges from 0 symptoms to 7 symptoms. Higher indicates more symptoms and worse dependence on high fat or high sugar foods.
Change in tobacco use frequency (non-ceremonial use) assessed by self-report
Tobacco use frequency will be assessed by 5 items on a 7-level ordinal scale from the YRBS 2023. With higher responses, reflecting greater tobacco use.
Change in alcohol use over time
Alcohol use (current use, binge drinking) assessed by the YRBS 2023.
Change in marijuana use over time
Past 30 day marijuana use (smoking, vaping, edibles) assessed by the YRBS 2023.
Change in drug and alcohol refusal self-efficacy
The Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) measure captures the perceived likelihood that youth will use drugs and alcohol in specific situations on a 3-point scale (Yes, No, Unsure). The SEDARE produces two scores ranging from 0 to 8. Higher scores reflect greater self-efficacy to refuse alcohol or drugs.

Full Information

First Posted
March 27, 2023
Last Updated
May 12, 2023
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05818384
Brief Title
Wakaya: Rising Up for Choctaw Youth Health
Acronym
Wakaya
Official Title
Wakaya: Rising Up for Choctaw Youth Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
March 30, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.
Detailed Description
Study participants will be recruited in staggered cohorts with those in each recruitment wave receiving individual-level random assignment to either immediate intervention or waitlist control (3 months wait to intervention) for a total of 176 Choctaw youth (ages 14-19 years) participating over 5 years. Recruitment strategies: The following Recruitment strategies will be used: posting flyers, posters and brochures in stores, community centers, and other locations identified by our community advisors; and posting flyers in the tribal newspaper, school newsletters, tribal gathering areas, tribal health fairs, pow wows, local boys and girls clubs, youth centers, other local news outlets, and on a study webpage. Screening: Participants will mainly be screened in-person, some may be screened over phone using the same talking points. Youth who are screened out will be given a community resource 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 youth who agree to participate will be asked to schedule their baseline assessment. After consent or assent and parental permission are obtained, CNO study staff will set up the study laptop and headphones that the participant will use to enter their responses to the baseline computer-assisted questionnaire. Assessments: The baseline assessment consists of a brief physical health assessment and a computer-assisted behavioral health survey administered by study staff. Youth participants are required to take a non-invasive physical health assessment (BMI with portable digital weight scale and height measure), identify the age they began puberty (girls < 12 years old began menstruation; boys <14 when voice changed "a lot" will be classified as early puberty) and to use an accelerometer for 7 days after the baseline assessment. They will also be asked to run or walk for 12 minutes. The computer-assisted behavioral health survey will ask a series of questions and take under 45 minutes to complete. The assessments will be conducted via Audio-Computer Assisted Self-Interviews (ACASI) programmed into study computers. Participants will complete 4 surveys: baseline, immediately after Trail of Tears Walk, a three-month follow up,and a six-month follow-up. Intervention Schedule: Month 1-3: Up to 20 group sessions on Choctaw history, traditions, cultural systems and health beliefs. 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 or increasing physical activity by walking or gardening. Fitbits will be given to participants and peers can choose to support each other to meet goals on a social media platform. Up to 3 individual Motivational Interviewing sessions to identify personal change goals and community leadership. Month 2-3: Attend an Overnight Culture Camp to strengthen group cohesion and synthesize goals. Month 3: Walk on the Choctaw Trail of Tears and visit ancient sites. Upon completion, make a commitment to conduct a community-wide event based on personal and leadership goals and Trail experience. Months 4-12: Up to 6 group meetings to plan community leadership events related to obesity prevention, includes an individual MI booster session to revise their personal & community leadership goals, digital storytelling training, and a community Traditional Games Olympiad. Participants may create a story related to healthful food habits, obesity prevention and alcohol, tobacco and other drug use (ATOD). Month 9: Share digital stories, community events, and participate in a leadership ceremony. Post-intervention: Ripple Effect Mapping focus groups among 64 individuals. A random selection of 12 youth per region and 4 nonparticipant community stakeholders i.e., elders, leaders in the community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Healthy Nutrition, Sedentary Behavior, Drug Abuse
Keywords
Native Americans, Youth, Oklahoma, Adolescents, Obesity prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wait List Control
Arm Type
Experimental
Arm Description
Participants in the Wait List group will be randomly assigned to start the intervention 3 months later in the Summer.
Arm Title
Wakaya (Immediate Group)
Arm Type
Experimental
Arm Description
Participants in the immediate group will be randomly assigned to start the intervention immediately in the Spring.
Intervention Type
Behavioral
Intervention Name(s)
Wakaya: Rising Up for Choctaw Youth Curriculum
Intervention Description
An experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.
Primary Outcome Measure Information:
Title
Change in physical activity assessed by self-report
Description
Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ) for youth and young adults. Results can be reported in categories (low, moderate or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); and 6 months post-intervention (month 9)
Title
Change in physical activity intensity associated with movement, measured by accelerometer
Description
An actigraph accelerometer measures vertical acceleration in counts per minute. It will be worn for 7 days. Mean counts per minute are calculated by dividing the sum of activity counts for a valid day be the number of minutes of wear time in a day for all valid days. Greater number of counts per minute indicates higher physical activity intensity. Change in mean counts per minute from baseline at 9 months will be assessed.
Time Frame
Baseline and 6 months post-intervention (month 9)
Title
Change in sedentary behaviors over time
Description
Measured by the Youth Leisure-time Sedentary Behavior Questionnaire (YLSBQ) adapted for Choctaw Youth
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in food and beverage habits over time
Description
Assessed by the Youth Risk Behavior Surveillance System (YRBS) 2023.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in beverage habits over time
Description
Assessed by the Modified Healthy Home Survey (2005- Beverages). It assesses the number of sweetened drinks consumed per week.
Time Frame
Baseline; post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI) change
Description
Mean or percentage change in BMI from baseline. Weight (kg) and height (meters) will be combined to report BMI as kg/m^2.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Weight change assessed via digital scale
Description
Mean weight change (kg)
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in food addiction
Description
The Yale Food Addiction Scale is a validated measure that has been developed to identify those who are most likely to be exhibiting markers of substance dependence with the consumption of high fat/high sugar foods. Food addiction (dichotomous) can be "diagnosed" when three symptoms and clinically significant impairment or distress are present. Continuous version of the scale ranges from 0 symptoms to 7 symptoms. Higher indicates more symptoms and worse dependence on high fat or high sugar foods.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in tobacco use frequency (non-ceremonial use) assessed by self-report
Description
Tobacco use frequency will be assessed by 5 items on a 7-level ordinal scale from the YRBS 2023. With higher responses, reflecting greater tobacco use.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in alcohol use over time
Description
Alcohol use (current use, binge drinking) assessed by the YRBS 2023.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in marijuana use over time
Description
Past 30 day marijuana use (smoking, vaping, edibles) assessed by the YRBS 2023.
Time Frame
Baseline; Immediate post-intervention (month 3); 3 months post (month 6); 6 months post-intervention (month 9)
Title
Change in drug and alcohol refusal self-efficacy
Description
The Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) measure captures the perceived likelihood that youth will use drugs and alcohol in specific situations on a 3-point scale (Yes, No, Unsure). The SEDARE produces two scores ranging from 0 to 8. Higher scores reflect greater self-efficacy to refuse alcohol or drugs.
Time Frame
Baseline; Immediate post-intervention (month 3) 3 months post (month 6); 6 months post-intervention (month 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be enrolled in Choctaw Nation of Oklahoma (CNO) Be enrolled in High School Live within CNO tribal region for 12 months YES to one of the following: Consumed sweetened beverages or processed/fast food 2x or more per week; OR Engaged in excessive sitting or lying around (>540 min/day) or engage in small screen recreation (>2 hours/day); OR Physical activity - spend <60 minutes/day outdoors or <2.5 hrs per week in moderate or vigorous physical activity OR spend <60 minutes a day in moderate or vigorous intensity aerobic activity; OR Engage in any T.V., small screen/video game recreation (> 2 hours/day) Exclusion Criteria: opioid/methamphetamine drug use (2 times or more in past month) allergic reactions to food (e.g. peanuts), plant (poison oak or ivy) or insects (e.g. bees, fire ants) that caused difficulty in breathing or necessitated hospitalization or caused an anaphylactic reaction disability that prevents student from walking or from engaging in exercise aggressive, violent, combative or inappropriate behaviors inability to follow directions psychotic symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domin Chan, MHS, PhD
Phone
206-221-3781
Email
dominc@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Johnson-Jennings, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Choctaw Nation of Oklahoma
City
Talihina
State/Province
Oklahoma
ZIP/Postal Code
74571
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessie N Roberts, MS, LPC
Phone
580-579-9867
Email
jnroberts@cnhsa.com
First Name & Middle Initial & Last Name & Degree
Stephen E Weeks, MS
Phone
918-558-0162
Email
seweeks@uw.edu
Facility Name
University of Washington, IWRI, School of Social Work
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domin Chan, MHS, PhD
Phone
206-221-3781
Email
dominc@uw.edu

12. IPD Sharing Statement

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Wakaya: Rising Up for Choctaw Youth Health

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