Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

Childhood Obesity Clinical Trial

Official title:

Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03986632
• Other study ID #: 2018-69001-27544
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: June 2019
• Source: University of Alaska Fairbanks
• Contact: Andrea Bersamin, PhD
• Phone: (907)474-6129
• Email: abersamin[@]alaska.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.

Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Tundra Gifts
Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Alaska Fairbanks	Alaska Native Tribal Health Consortium, Grand Valley State University, Pacific Institute for Research and Evaluation, State of Alaska Department of Health and Social Services, University of Alaska Anchorage

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in age- and sex-specific BMI percentiles and z-scores		twice annually for 3 years
Primary	Change in child intake of vegetables and fruit	24-hour recall in combination with a 2-day food record	twice annually for 3 years
Primary	Change in child intake of vegetables and fruit	Skin carotenoid meter using reflection spectroscopy (veggie-meter)	twice annually for 3 years
Primary	Change in child intake of sugar sweetened beverages	Hair biomarker of sugar using N and C stable isotope ratios	twice annually for 3 years
Primary	Change in child intake of sugar sweetened beverages	24-hour recall in combination with a 2-day food record	twice annually for 3 years
Primary	Change in child screen time	Screen time questionnaire	twice annually for 3 years
Primary	Change in child physical activity	Physical activity questionnaire	twice annually for 3 years
Secondary	Change in adult attitudes and beliefs around healthy eating and active lifestyle	Attitudes and beliefs questionnaire	twice annually for 3 years
Secondary	Change in adult BMI		twice annually for 3 years
Secondary	Change in adult intake of vegetables and fruit	skin carotenoid meter using reflection spectroscopy (veggie-meter)	twice annually for 3 years