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Obesity, ChildhoodNCT06298149

Reach Through Equitable Implementation of Turtle Island Tales

A study testing Turtle Island Tales in people with Obesity, Childhood and Obesity, run by Montana State University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood, Obesity, Cancer
What is being tested?
Turtle Island Tales
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Nov 2023to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Montana State University

    Bozeman, Montana, 59717

Other trials in United States

About this study

Official title: Reach Through Equitable Implementation of Turtle Island Tales in American Indian Communities: Program Effectiveness

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.

Read the 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.

Being tested
Turtle Island Tales
Medical subject headings
Pediatric Obesity, Obesity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Turtle Island TalesBehavioural

    All participating families 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.

Study groups in NCT06298149
Study groupRoleWhat they receive
Turtle Island TalesExperimentalAll participating families 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.
Receives: Behavioral: Turtle Island Tales

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 20-item Family Nutrition and Physical Activity Survey

    Pre- and post-evaluation of effectiveness in behavioral outcomes including family-level questions targeting diet, physical activity, screen time, and sleep. The total score is used as the summary score, with a higher score indicating a more positive family home environment relative to health behaviors.

    Measured: one year

Secondary outcomes (2)

  1. Food insecurity screener

    United States Department of Agriculture Household Food Insecurity 2-item screener: 1) "We worried whether our food would run out before we got money to buy more" and 2) "The food we bought just didn't last and we didn't have money to get more." An affirmative response ("Often True" or "Sometimes True") on either item is considered positive for food insecurity.

    Measured: one year

  2. Mental Health screening

    Two items from the validated Short Form-12 survey: 1) In the last month, how often have you felt that you were unable to control the important things in your life? and 2) In the last month, how often have you felt confident about your ability to handle your personal problems? Scores are summed, with a higher score being associated with more positive mental health status.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start1 Nov 2023
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06298149
Sponsor's protocol ID
2023-650-EXEMPT
Other IDs
1U54CA280812-01
Status last verified
Oct 2025
First submitted
13 Dec 2023
Last updated
15 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28064525

  • 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.

    PubMed 34222765

  • 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.

    PubMed 27913907

  • 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.

    PubMed 27211525

  • 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.

    PubMed 31453428

  • Tomayko EJ, Estabrooks PA, Warne TM, Merle JL, Adams AK. Documenting two decades of longitudinal changes to a community-engaged obesity prevention intervention for Native American families to facilitate scale-up. Transl Behav Med. 2026 Jan 7;16(1):ibag056. doi: 10.1093/tbm/ibag056.

    PubMed 42663129

Questions about this trial

What is this clinical trial studying?

A study testing Turtle Island Tales in people with Obesity, Childhood and Obesity, run by Montana State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

20-item Family Nutrition and Physical Activity Survey (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06298149, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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