Turtle Island Tales for Childhood Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montana State University

Disqualifiers: Residence outside poverty tracts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on a program called Turtle Island Tales, which aims to help American Indian families prevent childhood obesity by promoting healthy habits and family interaction. The program provides monthly lessons for a year, encouraging behaviors such as eating more fruits and vegetables, reducing sugar intake, increasing physical activity, limiting screen time, improving sleep, and managing emotions. It targets families living in areas with persistent poverty. Families with a caregiver over 18 years old and a child aged 3-8 living in these areas might be well-suited for this trial. As an unphased study, this trial offers families a unique opportunity to actively engage in a program designed to improve health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Turtle Island Tales intervention is safe for families?

Research shows limited information on the safety of Turtle Island Tales for addressing childhood obesity. However, the program promotes healthy habits such as eating more fruits and vegetables, reducing sugar intake, and increasing physical activity. These activities are generally safe and easy for most people.

The trial is marked as "Not Applicable" for the phase, indicating a non-invasive, educational focus. Programs like this typically present no major safety concerns. Turtle Island Tales aims to improve family wellness by emphasizing safe, positive lifestyle changes rather than medical treatments.

In summary, while specific safety data for Turtle Island Tales is lacking, the program's approach suggests it is likely safe for participating families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Turtle Island Tales because it offers a fresh approach to tackling childhood obesity through culturally relevant storytelling and family engagement. Unlike traditional treatments that often focus solely on diet and exercise, this program emphasizes holistic lifestyle changes, including healthy eating habits, increased physical activity, reduced screen time, better sleep, and emotional regulation. By incorporating monthly lessons into family routines, it aims to create lasting behavioral shifts in a fun and engaging way, potentially leading to more sustainable outcomes for children and their families.

What evidence suggests that Turtle Island Tales might be an effective treatment for childhood obesity?

Research has shown that Turtle Island Tales, the program under study in this trial to prevent obesity, is promising in helping American Indian families adopt healthier habits. Studies have found that this program, which combines diet changes and a type of talk therapy, works better than usual treatments for obesity. The program encourages eating more fruits and vegetables, reducing sugar intake, increasing physical activity, limiting screen time, improving sleep, and managing emotions. Early results suggest these activities help families live healthier lives, which can prevent obesity in children. Although specific long-term results are not yet available, this approach aligns well with proven methods for preventing obesity. ^{1 2 3 6 7}

Who Is on the Research Team?

Emily Tomayko, PhD

Principal Investigator

Montana State University

Are You a Good Fit for This Trial?

This trial is for American Indian families living in areas of persistent poverty, focusing on preventing obesity and related cancer risks. It aims to strengthen cultural values around family interaction and holistic wellness.

Inclusion Criteria

Residence in one of identified persistent poverty census tracts

Exclusion Criteria

I do not have children aged 3-8 years living with me.

Residence outside of identified persistent poverty census tracts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly lessons targeting healthy behaviors over the course of one year

12 months

Monthly lessons

Follow-up

Participants are monitored for effectiveness in behavioral outcomes using program evaluation survey data

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Turtle Island Tales

Trial Overview The intervention being studied is Turtle Island Tales, a program designed to promote healthy behaviors within AI families to prevent obesity and reduce the risk of cancer through culturally relevant methods.

How Is the Trial Designed?

Group I: Turtle Island Tales Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Montana State University

Lead Sponsor

Trials

47

Recruited

1,044,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A community-based obesity treatment program for children aged 6-15 years led to significant short-term improvements in weight-related measures, including a decrease in BMI by 0.65 kg/m² and waist circumference by 1.8 cm, among 2,812 participants.

Children who attended at least 75% of the program showed greater benefits in BMI reduction, self-esteem, and healthier dietary choices, highlighting the importance of program adherence for achieving positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational research: are community-based child obesity treatment programs scalable? Hardy, LL., Mihrshahi, S., Gale, J., et al.[2021]

A patient-centered decision tool was developed to help address childhood obesity by identifying common goals between parents and healthcare providers, based on qualitative interviews with 44 parents and focus groups with 81 participants.

The tool, which includes a modified growth chart and sections for discussing patient-centered goals, was found to be acceptable and potentially useful, highlighting the importance of engaging families in obesity interventions for Latino children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a patient-centered outcome for targeting early childhood obesity across multiple stakeholders. Foster, BA., Winkler, P., Weinstein, K., et al.[2022]

A comprehensive educational approach that involves both the child and their family is essential for effectively managing obesity in children, emphasizing the importance of motivational interviewing and parental involvement.

Long-term success in obesity care requires a flexible, step-by-step follow-up plan that allows for ongoing negotiation of goals between caregivers, the child, and their family, ensuring that management strategies are tailored to the child's specific situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PRIMARY CARE INTERVENTIONS FOR PEDIATRIC OVERWEIGHT OR OBESITY]. Jouret, B., Haupp, A.[2018]

A systematic review of 22 studies on weight loss camps for obese children showed that these immersion programs resulted in significantly greater weight loss compared to standard outpatient treatments, with an average of 191% greater reductions in percent-overweight immediately after treatment.

Programs that included cognitive-behavioral therapy (CBT) demonstrated even more impressive results, with a 30% reduction in percent-overweight at follow-up, compared to just 9% for programs without CBT, suggesting that the combination of structured environment and behavioral support is highly effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersion treatment of childhood and adolescent obesity: the first review of a promising intervention. Kelly, KP., Kirschenbaum, DS.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/-8xEJEGSikeqiJE5mk2BZg/project-details/10661441

Delivery of Turtle Island Tales to Promote Family Wellness Our objective is to increase the reach of EBIs for cancer and obesity prevention among AI families who live in persistent poverty areas (PPAs). The proposed ...

2. withpower.com withpower.com/trial/phase-obesity-10-2023-ac179

Turtle Island Tales for Childhood Obesity These programs, which include components such as controlled diet and cognitive-behavioral therapy, have been more effective than standard outpatient treatments.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06298149?locStr=United+States&country=United+States&aggFilters=healthy%3Ay%2Cstatus%3Anot+rec+enr+unk&firstPost=2024-01-01_

Reach Through Equitable Implementation of Turtle Island ... 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 ...

4. reporter.nih.gov reporter.nih.gov/search/kEbGvn8JzEiMLF35wrEWgw/project-details/11093934

RePORT RePORTER - National Institutes of Health (NIH) | Turtle Island Tales is a family-focused, home-based EBI for childhood obesity prevention named to acknowledge Turtle Island as the term for North America ...

5. trial.medpath.com trial.medpath.com/clinical-trial/469e33c9d1c08681/nct06298149-equitable-implementation-turtle-island-tales

Reach Through Equitable Implementation of Turtle Island Tales ... 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 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2211335521000383

Review article Effectiveness of programs aimed at obesity ... This systematic review of programs to prevent obesity among Indigenous children finds a limited impact on anthropometric measurements.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0081924

Childhood Onset Obesity (DBCOND0081924) | DrugBank Online Reach Through Equitable Implementation of Turtle Island Tales, No drug interventions, prevention, Not Available, enrolling_by_invitation. NCT00536536.