Childhood ObesityNCT03986632
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
A study testing Tundra Gifts in people with Childhood Obesity, run by University of Alaska Fairbanks.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Tundra Gifts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Childhood Obesity
- Being tested
- Tundra Gifts
- Keywords
- Healthy Eating, Alaska Native, Traditional Foods
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tundra GiftsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tundra gifts program | Experimental | Not described Receives: Behavioral: Tundra Gifts |
| Comparison | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in age- and sex-specific BMI percentiles and z-scores
Measured: twice annually for 3 years
Change in child intake of vegetables and fruit
24-hour recall in combination with a 2-day food record
Measured: twice annually for 3 years
Change in child intake of vegetables and fruit
Skin carotenoid meter using reflection spectroscopy (veggie-meter)
Measured: twice annually for 3 years
Change in child intake of sugar sweetened beverages
Hair biomarker of sugar using N and C stable isotope ratios
Measured: twice annually for 3 years
Change in child intake of sugar sweetened beverages
24-hour recall in combination with a 2-day food record
Measured: twice annually for 3 years
Change in child screen time
Screen time questionnaire
Measured: twice annually for 3 years
Change in child physical activity
Physical activity questionnaire
Measured: twice annually for 3 years
Secondary outcomes (3)
Change in adult attitudes and beliefs around healthy eating and active lifestyle
Attitudes and beliefs questionnaire
Measured: twice annually for 3 years
Change in adult BMI
Measured: twice annually for 3 years
Change in adult intake of vegetables and fruit
skin carotenoid meter using reflection spectroscopy (veggie-meter)
Measured: twice annually for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alaska Fairbanks
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium
- Responsible party
- Principal investigator, Andrea Bersamin, University of Alaska Fairbanks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986632
- Sponsor's protocol ID
- 2018-69001-27544
- Other IDs
- 2018
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
- ClinicalTrials.gov ID
- NCT03986632
- Acronym / sponsor ID
- 2018-69001-27544
- Conditions
- Childhood Obesity
- Keywords
- Healthy Eating, Alaska Native, Traditional Foods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Alaska FairbanksUniversity, hospital or other
- Collaborators
- Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tundra gifts program | Experimental | Behavioral: Tundra Gifts |
| Comparison | No intervention | – |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tundra GiftsTundra 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. | Behavioural | Tundra gifts program |
Primary outcome
Change in age- and sex-specific BMI percentiles and z-scores
Time frame: twice annually for 3 years
Change in child intake of vegetables and fruit
Time frame: twice annually for 3 years
24-hour recall in combination with a 2-day food record
Change in child intake of vegetables and fruit
Time frame: twice annually for 3 years
Skin carotenoid meter using reflection spectroscopy (veggie-meter)
Change in child intake of sugar sweetened beverages
Time frame: twice annually for 3 years
Hair biomarker of sugar using N and C stable isotope ratios
Change in child intake of sugar sweetened beverages
Time frame: twice annually for 3 years
24-hour recall in combination with a 2-day food record
Change in child screen time
Time frame: twice annually for 3 years
Screen time questionnaire
Change in child physical activity
Time frame: twice annually for 3 years
Physical activity questionnaire
3 secondary outcomes
Change in adult attitudes and beliefs around healthy eating and active lifestyle
Time frame: twice annually for 3 years
Change in adult BMI
Time frame: twice annually for 3 years
Change in adult intake of vegetables and fruit
Time frame: twice annually for 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tundra Gifts in people with Childhood Obesity, run by University of Alaska Fairbanks.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Bersamin, PhD ((907)474-6129, abersamin@alaska.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in age- and sex-specific BMI percentiles and z-scores (time frame: twice annually for 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2019.