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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027629 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Alaska Fairbanks | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and self-efficacy coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald L Chi, DDS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Dentistry | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39489399 | Derived | 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. |
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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 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.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | This arm includes child participants and their caregivers from two communities (intervention community A and intervention community B). The participants in these communities 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. |
| FG001 | Comparison Arm | This arm includes child participants and their caregivers from one community (community C) and 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children and primary caregivers represent the overall number of baseline participants. Households are also considered as a unit of analysis. Multiple caregivers of child participants were enrolled in some households, but only after baseline. Baseline data was only collected for primary caregivers, so the number of households in each arm by proxy represents the number of caregivers with baseline characteristics analyzed.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child participant age | Child participants in the intervention arm at baseline N=143. Child participants in the comparison arm N=58 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | g/day | Baseline to 6 months |
|
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.
Adverse events data were collected in two ways throughout the study from day 3 after baseline to 12-months: (1) participants could self-report adverse events to the community health worker they interacted with during study intervention visits; or (2) study staff probed for adverse events during data collection visits at 1-month, 3-months, 6-months and 12-months. Adverse events data were NOT collected in the comparison arm since that arm were not exposed to the sugar-free Kool-aid.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Children (N=143) and all caregivers enrolled throughout the duration of the study (N=99) from the intervention arm, where sugar free-Kool aid was introduced in community A and community B. Adverse events data were NOT collected in the comparison arm since that arm were not exposed to the sugar-free Kool-aid. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| [child] Upset stomach (possible relation) | Gastrointestinal disorders | Systematic Assessment | Child participants reported experiencing mild side-effects of having an upset stomach that they believe was possibly due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers. |
Allocation was not randomized. Communities were allocated to the intervention arm vs. control arm based on readiness to participate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donald L. Chi | University of Washington | 206-616-4332 | dchi@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 12, 2023 | Mar 27, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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.
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All raw data provided to the statistician will include a participant-level variable indicating the community in which the participant lives.
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Households (primary caregivers) |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
|
| Age, Continuous | Primary caregiver age | Mean | Standard Deviation | years | Households (primary caregivers) |
|
|
| Sex: Female, Male | Child participant sex | Child participants in intervention arm N=143. Child participants in comparison arm N=58 | Count of Participants | Participants | Participants |
|
|
| Sex: Female, Male | Primary caregiver sex | Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27. | Count of Units | Households (primary caregivers) | Households (primary caregivers) |
|
|
| Race/Ethnicity, Customized | Child participant and primary caregiver race. Alaskan native (Yup'ik) race/ethnicity was part of the inclusion criteria for all participants. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Child participants (N=143) and primary caregivers (N=77) region of enrollment. | Number | participants | Participants |
|
|
| Children in the household | The total number of children in each household was measured, including enrolled child participants. | Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled. Multiple children from the same household could be enrolled. | Mean | Standard Deviation | number of children | Households (primary caregivers) |
|
|
| Household size | The number of people living in each household including children and adults was measured at baseline. | Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled. Multiple children from the same household could be enrolled. | Mean | Standard Deviation | people | Households (primary caregivers) |
|
|
| Household income | Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled. | Count of Units | Households (primary caregivers) | Households (primary caregivers) |
|
|
| Money for utilities | Responses to this question from primary caregivers were collected at baseline: "How often does money for household utilities (i.e., water, fuel oil, electricity, etc.) run out before the end of the month?" | Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled. | Count of Units | Households (primary caregivers) | Households (primary caregivers) |
|
|
| Traditional Yup'ik Lifestyle | Responses to this question were collected from primary caregivers at baseline: "How much do you follow the traditional Yup'ik way of life?" | Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled. Multiple children from the same household could be enrolled. | Count of Units | Households (primary caregivers) | Households (primary caregivers) |
|
|
Children from the intervention community A and community B
| OG001 | Comparison Arm | Children from the control community C, who did not receive the intervention. |
|
|
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | g/day | Baseline to 6 months |
|
|
|
|
| 0 |
| 242 |
| 0 |
| 242 |
| 8 |
| 242 |
|
| [child] Upset stomach (probable relation) | Gastrointestinal disorders | Systematic Assessment | Child participants reported experiencing mild side-effects of having an upset stomach that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers. |
|
| [child] Diarrhea (possible relation) | Gastrointestinal disorders | Systematic Assessment | Child participants reported experiencing mild side-effects of having diarrhea that they believe was possibly due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers. |
|
| [child] Diarrhea (probable relation) | Gastrointestinal disorders | Systematic Assessment | Child participants reported experiencing mild side-effects of having diarrhea that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers. |
|
| [caregiver] Diarrhea (probable relation) | Gastrointestinal disorders | Systematic Assessment | Adult participants reported experiencing mild side-effects of having diarrhea that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers. |
|
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| $15,000 to $24,999 |
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| $25,000 to $34,999 |
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| $35,000 to $49,999 |
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| $50,000 to $74,999 |
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| $75,000 to $99,999 |
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| Refused/Did not wish to answer |
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| Sometimes |
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| Most times |
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| Always |
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| Refused/Did not wish to answer |
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| Rarely |
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| Never |
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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). |
| Regression, Linear |
| 0.013 |
The P-value is unadjusted. The threshold for significance is 0.05. |
| Mean Difference (Final Values) |
| -24.7 |
| 2-Sided |
| 95 |
| -44.1 |
| -5.4 |
| Superiority |