Clinical trial NCT06298149: Reach Through Equitable Implementation of Turtle Island Tales
Official title: Reach Through Equitable Implementation of Turtle Island Tales in American Indian Communities: Program Effectiveness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity, Childhood
Obesity
Cancer
Lead sponsor: Montana State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Utah
name: National Cancer Institute (NCI)
First posted: 2024-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year.
Primary purpose: PREVENTION

Brief summary: Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts.

Detailed description: Turtle Island Tales is an obesity prevention program for AI families with young children (3-8 years) that was developed to address the gap in home-based, family wellness programs for this population. Substantial research as been conducted on the effectiveness of this program for participating families. The primary aim of the current project is to investigate community-engaged dissemination to improve the reach of Turtle Island Tales. Dissemination strategies will be undertaken in partnership with community leaders and/or local Supplemental Nutrition Assistance Program Education (SNAP-Ed) agents who will disseminate the program through existing Extension/SNAP-Ed delivery mechanisms (SNAP-Ed is commonly administered through Extension programs of land-grant universities). Turtle Island Tales was accepted as a SNAP-Ed eligible program in 2022. As such, the program will be administered as part of usual/typical SNAP-Ed delivery in participating communities and largely constitutes program evaluation.

The primary research question is: What is the reach of the evidence-based Turtle Island Tales wellness program intervention within AI communities? A secondary aim for this project is determining the effectiveness of Turtle Island Tales among participating families using program evaluation survey data obtained via SNAP-Ed program evaluation.

Eligibility criteria: Inclusion Criteria:

* Residence in one of identified persistent poverty census tracts
* Person \>18 years of age caring for a child 3-8 years old

Exclusion Criteria:

* Residence outside of identified persistent poverty census tracts
* Caregiver \<18 years of age
* No child 3-8 years old living in household

Primary outcomes:
measure: 20-item Family Nutrition and Physical Activity Survey
timeFrame: one year
Secondary outcomes:
measure: Food insecurity screener
timeFrame: one year
measure: Mental Health screening
timeFrame: one year
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
affiliation: Montana State University
name: Emily Tomayko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomayko EJ, Prince RJ, Cronin KA, Parker T, Kim K, Grant VM, Sheche JN, Adams AK. Healthy Children, Strong Families 2: A randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches. Clin Trials. 2017 Apr;14(2):152-161. doi: 10.1177/1740774516685699. Epub 2017 Jan 9.
citation: Tomayko EJ, Webber EJ, Cronin KA, Prince RJ, Adams AK. Use of Text Messaging and Facebook Groups to Support the Healthy Children, Strong Families 2 Healthy Lifestyle Intervention for American Indian Families. Curr Dev Nutr. 2021 May 17;5(Suppl 4):32-39. doi: 10.1093/cdn/nzaa110. eCollection 2021 Jun.
citation: Berns RM, Tomayko EJ, Cronin KA, Prince RJ, Parker T, Adams AK. Development of a Culturally Informed Child Safety Curriculum for American Indian Families. J Prim Prev. 2017 Apr;38(1-2):195-205. doi: 10.1007/s10935-016-0459-y.
citation: Tomayko EJ, Prince RJ, Cronin KA, Adams AK. The Healthy Children, Strong Families intervention promotes improvements in nutrition, activity and body weight in American Indian families with young children. Public Health Nutr. 2016 Oct;19(15):2850-9. doi: 10.1017/S1368980016001014. Epub 2016 May 23.
citation: Tomayko EJ, Prince RJ, Cronin KA, Kim K, Parker T, Adams AK. The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children. Curr Dev Nutr. 2018 Nov 16;3(Suppl 2):53-62. doi: 10.1093/cdn/nzy087. eCollection 2019 Aug.