NCT03986632

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

June 2, 2019

Last Update Submit

June 12, 2019

Conditions

Keywords

Healthy EatingAlaska NativeTraditional Foods

Outcome Measures

Primary Outcomes (7)

  • Change in age- and sex-specific BMI percentiles and z-scores

    twice annually for 3 years

  • Change in child intake of vegetables and fruit

    24-hour recall in combination with a 2-day food record

    twice annually for 3 years

  • Change in child intake of vegetables and fruit

    Skin carotenoid meter using reflection spectroscopy (veggie-meter)

    twice annually for 3 years

  • Change in child intake of sugar sweetened beverages

    Hair biomarker of sugar using N and C stable isotope ratios

    twice annually for 3 years

  • Change in child intake of sugar sweetened beverages

    24-hour recall in combination with a 2-day food record

    twice annually for 3 years

  • Change in child screen time

    Screen time questionnaire

    twice annually for 3 years

  • Change in child physical activity

    Physical activity questionnaire

    twice annually for 3 years

Secondary Outcomes (3)

  • Change in adult attitudes and beliefs around healthy eating and active lifestyle

    twice annually for 3 years

  • Change in adult BMI

    twice annually for 3 years

  • Change in adult intake of vegetables and fruit

    twice annually for 3 years

Study Arms (2)

Tundra gifts program

EXPERIMENTAL
Behavioral: Tundra Gifts

Comparison

NO INTERVENTION

Interventions

Tundra GiftsBEHAVIORAL

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.

Tundra gifts program

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Bersamin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 14, 2019

Study Start

September 1, 2019

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

June 14, 2019

Record last verified: 2019-06