Healthy
Conditions
Keywords
Alaska Native, children, sugared fruit drinks, sugar sweetened beverages, oral health, dental
Brief 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).
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.
Interventions
BEHAVIORALEducation and self-efficacy coaching
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.
Sponsors
University of Alaska Fairbanks
National Institute of Dental and Craniofacial Research (NIDCR)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
All raw data provided to the statistician will include a participant-level variable indicating the community in which the participant lives.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Added Sugar Intake Among Children | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Added Sugar Intake Among Caregivers | Baseline to 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by phone and local radio in the communities between 8/26/2022 and 9/16/2022. Participants were screened and enrolled at the community clinics. In the two intervention group communities, 143 children and 81 caregivers were enrolled between 9/6/2022 and 9/13/2022. In the control group community, 58 children and 27 caregivers were enrolled at the community clinic between 9/14/2022 and 9/16/2022. Additional (secondary) caregivers were enrolled at subsequent visits.
Pre-assignment details
Primary caregivers were enrolled and assigned to units (households). Multiple children could be enrolled from the same household. If the primary caregiver enrolled at baseline was not available, additional (secondary) caregivers were enrolled after baseline.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm This arm includes child participants and their caregivers from two communities that will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers.
Education and self-efficacy coaching: 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 will carry the sugar-free water enhancers that are highlighted in the health education. | 220 |
| Intervention Arm This arm includes child participants and their caregivers from two communities that will receive education, behavior change support in the form of self-efficacy coaching, and introduction of sugar-free water enhancers.
Education and self-efficacy coaching: 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 will carry the sugar-free water enhancers that are highlighted in the health education. | 77 |
| Comparison Arm This arm includes child participants and caregivers from one community that 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. | 85 |
| Comparison Arm This arm includes child participants and caregivers from one community that 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. | 27 |
| Total | 409 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 0 |
Baseline characteristics
| Characteristic | Intervention Arm | Comparison Arm | Total |
|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 11.75 | 36.7 years STANDARD_DEVIATION 10.4 | 37.3 years STANDARD_DEVIATION 11.3 |
| Children in the household | 3.4 number of children STANDARD_DEVIATION 2 | 3.5 number of children STANDARD_DEVIATION 1.3 | 3.4 number of children STANDARD_DEVIATION 1.9 |
| Household income $10,000 to $14,999 | 12 Households (primary caregivers) | 2 Households (primary caregivers) | 14 Households (primary caregivers) |
| Household income $15,000 to $24,999 | 13 Households (primary caregivers) | 4 Households (primary caregivers) | 17 Households (primary caregivers) |
| Household income $25,000 to $34,999 | 3 Households (primary caregivers) | 4 Households (primary caregivers) | 7 Households (primary caregivers) |
| Household income $35,000 to $49,999 | 0 Households (primary caregivers) | 1 Households (primary caregivers) | 1 Households (primary caregivers) |
| Household income $50,000 to $74,999 | 3 Households (primary caregivers) | 4 Households (primary caregivers) | 7 Households (primary caregivers) |
| Household income $75,000 to $99,999 | 3 Households (primary caregivers) | 1 Households (primary caregivers) | 4 Households (primary caregivers) |
| Household income less than $10,000 | 28 Households (primary caregivers) | 6 Households (primary caregivers) | 34 Households (primary caregivers) |
| Household income Refused/Did not wish to answer | 15 Households (primary caregivers) | 5 Households (primary caregivers) | 20 Households (primary caregivers) |
| Household size | 6.4 people STANDARD_DEVIATION 2.6 | 6.1 people STANDARD_DEVIATION 1.7 | 6.2 people STANDARD_DEVIATION 2.6 |
| Money for utilities Always | 6 Households (primary caregivers) | 1 Households (primary caregivers) | 7 Households (primary caregivers) |
| Money for utilities Most times | 14 Households (primary caregivers) | 1 Households (primary caregivers) | 15 Households (primary caregivers) |
| Money for utilities Never | 24 Households (primary caregivers) | 8 Households (primary caregivers) | 32 Households (primary caregivers) |
| Money for utilities Refused/Did not wish to answer | 4 Households (primary caregivers) | 1 Households (primary caregivers) | 5 Households (primary caregivers) |
| Money for utilities Seldom | 9 Households (primary caregivers) | 4 Households (primary caregivers) | 13 Households (primary caregivers) |
| Money for utilities Sometimes | 20 Households (primary caregivers) | 12 Households (primary caregivers) | 32 Households (primary caregivers) |
| Race/Ethnicity, Customized Alaskan Native, Yup'ik | 220 Participants | 85 Participants | 305 Participants |
| Region of Enrollment United States | 220 participants | 85 participants | 201 participants |
| Sex: Female, Male Female | 65 Participants | 26 Households (primary caregivers) | 89 Participants |
| Sex: Female, Male Male | 78 Participants | 34 Participants | 14 Households (primary caregivers) |
| Traditional Yup'ik Lifestyle A lot | 53 Households (primary caregivers) | 17 Households (primary caregivers) | 70 Households (primary caregivers) |
| Traditional Yup'ik Lifestyle Never | 0 Households (primary caregivers) | 0 Households (primary caregivers) | 0 Households (primary caregivers) |
| Traditional Yup'ik Lifestyle Rarely | 0 Households (primary caregivers) | 0 Households (primary caregivers) | 0 Households (primary caregivers) |
| Traditional Yup'ik Lifestyle Sometimes | 24 Households (primary caregivers) | 10 Households (primary caregivers) | 34 Households (primary caregivers) |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 242 |
| other Total, other adverse events | 8 / 242 |
| serious Total, serious adverse events | 0 / 242 |
Outcome results
Primary
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.
Time frame: Baseline to 6 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Change in Added Sugar Intake Among Children | 11.7 g/day |
| Comparison Arm | Change in Added Sugar Intake Among Children | 19.1 g/day |
Comparison: Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).p-value: 0.1795% CI: [-3.2, 18]Regression, Linear
Secondary
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.
Time frame: Baseline to 6 months
Population: Analysis measuring change in added sugar intake (grams per day) from baseline to 6-months was conducted with available hair biomarker data for caregivers who had hair specimens collected at both events. Out of 42 caregivers in community A, 35 in community B, and 27 in community C, with hair samples collected at baseline in the intervention arms, 23, 24, and 19 respectively, also had hair samples collected at 6-months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Change in Added Sugar Intake Among Caregivers | 13.6 g/day |
| Comparison Arm | Change in Added Sugar Intake Among Caregivers | 33.3 g/day |
| Comparison Arm | Change in Added Sugar Intake Among Caregivers | 8.5 g/day |
Comparison: Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).p-value: 0.695% CI: [-24.3, 14]Regression, Linear
Comparison: Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).p-value: 0.01395% CI: [-44.1, -5.4]Regression, Linear