HealthyNCT05219448

Reducing Sugared Fruit Drinks in Alaska Native Children

A study testing Education and self-efficacy coaching in people with Healthy, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study in Alaska will test whether providing sugar-free alternatives to sugared fruit drinks and introducing education and social support will help families and children to reduce the amount of sugared fruit drinks consumed (measured through the primary outcome of added sugar intake). Read more about this study

Who is it for?: Ages 1 year to 11 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Education and self-efficacy coaching
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 334 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2022to 13 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Child must be older than age 1 year but less than age 12 years at time of enrollment. Multiple children from the same family are eligible;
Child must live in one of the study communities at baseline;
Child's parent or primary caregiver must of Yup'ik descent, be age 18 years or older, and willing to provide written consent to study procedures;
Child participant(s) ages 8 to 11 years must be willing to provide written assent to study procedures;
Willing to comply with all study procedures and be available for the duration of the study.

Who cannot join

Severe medical condition that would prevent the child from completing the study procedures;
Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free water enhancers) as defined by parent report of any known allergies;
Sulfa drug allergy (potential hypersensitivity to acesulfame potassium);
Member of the same household as the Community Health Worker who will be delivering the intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington School of Dentistry
Seattle, Washington, 98195

Other trials in United States

About this study

Read the detailed description

Alaska Native children consume an average of 50 teaspoons of sugar per day and most of this added sugar is from fruit drinks like Tang and Kool-Aid. The goal of this community-based behavioral trial is to reduce added sugar intake in Alaska Native children. In Communities A and B, a total of 136 children ages 1-11 years will be recruited for a 6-month culturally-adapted, 5-session intervention consisting of video-based health education and self-efficacy coaching delivered in person by an indigenous Community Health Worker. There will be 4 brief "check-ins" to provide social support. Local stores have been recruited to carry sugar-free fruit drinks. In Community C, 56 children will be recruited to a no treatment control group. Outcomes will be measured at baseline, 1, 3, 6, and 12 months.

Conditions: Healthy
Being tested: Education and self-efficacy coaching
Keywords: Alaska Native, children, sugared fruit drinks, sugar sweetened beverages, oral health, dental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Education and self-efficacy coachingBehavioural
Children and their caregiver(s) in the intervention communities will receive a culturally-adapted, 5-session program consisting of video-based health education and self-efficacy coaching delivered by an indigenous Community Health Worker. Families will be introduced to sugar-free water enhancers that are commercially available and come in the same flavors as regular Tang and Kool-Aid. The sessions will include conversations on related topics, interactive hands-on activities, and homework assignments. Additionally, four brief "check-ins" will keep families engaged. Local stores in the intervention communities only will carry the sugar-free water enhancers that are highlighted in the health education.

Study groups in NCT05219448
Study group	Role	What they receive
Education and self-efficacy coaching	Experimental	This arm will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers. Receives: Behavioral: Education and self-efficacy coaching
Comparison	No intervention	This arm will have the outcomes assessed but will not receive relevant parts of the intervention (education, behavior change support, and introduction of sugar-free water enhancers) until the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Added Sugar Intake Among Children
Added sugar intake among children will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair using coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day.
Measured: Baseline to 6 months

Secondary outcomes (1)

Change in Added Sugar Intake Among Caregivers
Added sugar intake among caregivers will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair, based on coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day.
Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 202213 Mar 2024

First posted2 Feb 2022
Study start6 Sep 2022
Primary completion28 Mar 2023
Study completion13 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Model description: There are 2 arms in the study. In Communities A and B, a total of 136 children (and at least one primary caregiver for each child) will be recruited for the intervention and outcomes measured over 12 months. In Community C, 56 children (and at least one primary caregiver for each child) will be recruited to a control group where outcomes are measured over 12 months but the intervention is not delivered until the study data collection period is over.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05219448
Sponsor's protocol ID: STUDY00009185
Other IDs: U01DE027629
Status last verified: Jul 2024
First submitted: 7 Jan 2022
Last updated: 29 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chi DL, Lewis FM, Weinstein P, Mancl L, Milgrom P, Edwards T, Coldwell S, O'Brien D, Bersamin A, Hopkins S, Orr E, Rivera P, Lenaker D, Sylvetsky A, Gittelsohn J, Walter P, Randall CL, Wiseman D, Dock A, Ko A, Orack J, Nemawarkar D, Panchal S, Soper J, Hill CM, Kerr D, Nguyen DP, Chen CY, MacLachlan E. Healthy Drinks, Healthy Teeth - Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta. Contemp Clin Trials. 2024 Dec;147:107734. doi: 10.1016/j.cct.2024.107734. Epub 2024 Nov 1.
PubMed 39489399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Sugared Fruit Drinks in Alaska Native Children
ClinicalTrials.gov ID: NCT05219448
Acronym / sponsor ID: STUDY00009185
Conditions: Healthy
Keywords: Alaska Native, children, sugared fruit drinks, sugar sweetened beverages, oral health, dental
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: University of Alaska Fairbanks, National Institute of Dental and Craniofacial Research (NIDCR)
Study start: 6 Sep 2022 (actual)
Primary completion: 28 Mar 2023 (actual)
Study completion: 13 Mar 2024 (actual)
First posted: 2 Feb 2022 (actual)
Results: Posted 29 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: There are 2 arms in the study. In Communities A and B, a total of 136 children (and at least one primary caregiver for each child) will be recruited for the intervention and outcomes measured over 12 months. In Community C, 56 children (and at least one primary caregiver for each child) will be recruited to a control group where outcomes are measured over 12 months but the intervention is not delivered until the study data collection period is over.

Arm	Type	Receives
Education and self-efficacy coaching	Experimental	Behavioral: Education and self-efficacy coachingThis arm will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers.
Comparison	No intervention	–This arm will have the outcomes assessed but will not receive relevant parts of the intervention (education, behavior change support, and introduction of sugar-free water enhancers) until the end of the study.

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Child must be older than age 1 year but less than age 12 years at time of enrollment. Multiple children from the same family are eligible;
Child must live in one of the study communities at baseline;
Child's parent or primary caregiver must of Yup'ik descent, be age 18 years or older, and willing to provide written consent to study procedures;
Child participant(s) ages 8 to 11 years must be willing to provide written assent to study procedures;
Willing to comply with all study procedures and be available for the duration of the study.

Key exclusion criteria (4 listed)

Severe medical condition that would prevent the child from completing the study procedures;
Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free water enhancers) as defined by parent report of any known allergies;
Sulfa drug allergy (potential hypersensitivity to acesulfame potassium);
Member of the same household as the Community Health Worker who will be delivering the intervention.

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
Education and self-efficacy coachingChildren and their caregiver(s) in the intervention communities will receive a culturally-adapted, 5-session program consisting of video-based health education and self-efficacy coaching delivered by an indigenous Community Health Worker. Families will be introduced to sugar-free water enhancers that are commercially available and come in the same flavors as regular Tang and Kool-Aid. The sessions will include conversations on related topics, interactive hands-on activities, and homework assignments. Additionally, four brief "check-ins" will keep families engaged. Local stores in the intervention communities only will carry the sugar-free water enhancers that are highlighted in the health education.	Behavioural	Education and self-efficacy coaching

Primary outcome

Change in Added Sugar Intake Among Children
Time frame: Baseline to 6 months
Added sugar intake among children will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair using coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day.

1 secondary outcome

Change in Added Sugar Intake Among Caregivers
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 29 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	241	232
Comparison Arm	93	93

Primary outcome: Change in Added Sugar Intake Among Children

Time frame: Baseline to 6 months. Mean (95% Confidence Interval). Unit: g/day

Measure	Intervention Arm n = 90	Comparison Arm n = 38
Value	11.7 (5.7 to 17.7)	19.1 (10.2 to 28.0)

Intervention Arm vs Comparison Arm: Mean Difference (Final Values): 7.4 (95% CI -3.2 to 18.0), p = 0.17, Regression, Linear

Population analysed: Analysis measuring change in added sugar intake (grams per day) from baseline to 6-months was conducted with available hair biomarker data for children who had hair specimens collected at both events. Out of 143 children with hair samples collected at baseline in the intervention arm, 90 also had hair samples collected at 6-months. Out of 58 children with hair samples collected at baseline in the comparison arm, 38 also had hair samples collected at 6-months.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from day 3 after baseline (after the sugar-free Kool-aid was introduced), up to the final data collection visit at 12-months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	0 of 242 (0%)	8 of 242 (3.3%)	0 of 242

Limitations and caveats (from the sponsor): Allocation was not randomized. Communities were allocated to the intervention arm vs. control arm based on readiness to participate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39489399Chi DL, Lewis FM, Weinstein P, Mancl L, Milgrom P, Edwards T, Coldwell S, O'Brien D, Bersamin A, Hopkins S, Orr E, Rivera P, Lenaker D, Sylvetsky A, Gittelsohn J, Walter P, Randall CL, Wiseman D, Dock A, Ko A, Orack J, Nemawarkar D, Panchal S, Soper J, Hill CM, Kerr D, Nguyen DP, Chen CY, MacLachlan E. Healthy Drinks, Healthy Teeth - Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta. Contemp Clin Trials. 2024 Dec;147:107734. doi: 10.1016/j.cct.2024.107734. Epub 2024 Nov 1.
Individual participant dataSharing planned: No

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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.

Donald L Chi, DDS, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education and self-efficacy coaching in people with Healthy, run by University of Washington at 1 site in United States.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Added Sugar Intake Among Children (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219448, which also lists 1 linked publication.

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 29 Jul 2024.