- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298149
Reach Through Equitable Implementation of Turtle Island Tales
Reach Through Equitable Implementation of Turtle Island Tales in American Indian Communities: Program Effectiveness
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59717
- Montana State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Turtle Island Tales
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
20-item Family Nutrition and Physical Activity Survey
Time Frame: one year
|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food insecurity screener
Time Frame: one year
|
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.
|
one year
|
|
Mental Health screening
Time Frame: one year
|
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.
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Tomayko, PhD, Montana State University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-650-EXEMPT
- 1U54CA280812-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Turtle Island Tales
-
University of Maryland, College ParkCompletedAnxiety | Behavioral InhibitionUnited States
-
Trakya UniversityCompletedSatisfaction | Fear AnxietyTurkey
-
The Second Hospital of TangshanChinese PLA General Hospital; The Second Hospital of QinhuangdaoCompleted
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesityUnited States
-
Ataturk UniversityNot yet recruiting
-
The Second Hospital of TangshanChinese PLA General HospitalCompletedSensory Reconstruction of the Volar Aspect of the Finger | The Heterodigital Neurocutaneous Island FlapChina
-
Gamze AkayAtaturk UniversityCompleted
-
University of Maryland, College ParkCompletedAnxiety | Behavioral InhibitionUnited States
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesityUnited States
-
Sheba Medical CenterWithdrawnImpaired Balance in ElderlyIsrael