Trial Outcomes & Findings for Reducing Sugared Fruit Drinks in Alaska Native Children (NCT NCT05219448)

NCT ID: NCT05219448

Last Updated: 2024-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

334 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2024-07-29

Participant Flow

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.

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.

Unit of analysis: Community

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	241 2	93 1
Overall Study Baseline	220 2	85 1
Overall Study 1-month Data Collection	231 2	91 1
Overall Study 3-month Data Collection	234 2	93 1
Overall Study 6-month Data Collection	231 2	93 1
Overall Study 12-month Data Collection	232 2	93 1
Overall Study COMPLETED	232 2	93 1
Overall Study NOT COMPLETED	9 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	9	0

Baseline Characteristics

Child participants in the intervention arm at baseline N=143. Child participants in the comparison arm N=58

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=90 Participants Children from the intervention community A and community B	Comparison Arm n=38 Participants Children from the control community C, who did not receive the intervention.	Comparison Arm Caregivers from the control arm, community C.
Change in Added Sugar Intake Among Children	11.7 g/day Interval 5.7 to 17.7	19.1 g/day Interval 10.2 to 28.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Arm n=23 Participants Children from the intervention community A and community B	Comparison Arm n=24 Participants Children from the control community C, who did not receive the intervention.	Comparison Arm n=19 Participants Caregivers from the control arm, community C.
Change in Added Sugar Intake Among Caregivers	13.6 g/day Interval 1.5 to 25.7	33.3 g/day Interval 20.8 to 45.7	8.5 g/day Interval -6.3 to 23.3

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Arm n=242 participants at risk 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.
Gastrointestinal disorders [child] Upset stomach (possible relation)	0.41% 1/242 • Number of events 1 • 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.
Gastrointestinal disorders [child] Upset stomach (probable relation)	0.83% 2/242 • Number of events 2 • 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.
Gastrointestinal disorders [child] Diarrhea (possible relation)	0.83% 2/242 • Number of events 2 • 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.
Gastrointestinal disorders [child] Diarrhea (probable relation)	0.83% 2/242 • Number of events 3 • 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.
Gastrointestinal disorders [caregiver] Diarrhea (probable relation)	0.41% 1/242 • Number of events 1 • 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.

Additional Information

Dr. Donald L. Chi

University of Washington

Phone: 206-616-4332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention Arm n=77 Households (primary caregivers) 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.	Comparison Arm n=27 Households (primary caregivers) 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.	Total n=104 Households (primary caregivers) Total of all reporting groups
Age, Continuous	37.6 years STANDARD_DEVIATION 11.75 • n=77 Households (primary caregivers)	36.7 years STANDARD_DEVIATION 10.4 • n=27 Households (primary caregivers)	37.3 years STANDARD_DEVIATION 11.3 • n=104 Households (primary caregivers)
Sex: Female, Male Female	64 Households (primary caregivers) n=77 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.	26 Households (primary caregivers) n=27 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.	90 Households (primary caregivers) n=104 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.
Sex: Female, Male Male	13 Households (primary caregivers) n=77 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.	14 Households (primary caregivers) n=104 Households (primary caregivers) • Primary caregivers in intervention arm N=77. Primary caregiver in comparison arm N=27.
Race/Ethnicity, Customized Alaskan Native, Yup'ik	220 Participants n=220 Participants	85 Participants n=85 Participants	305 Participants n=305 Participants
Region of Enrollment United States	220 participants n=220 Participants	85 participants n=85 Participants	201 participants n=305 Participants
Children in the household	3.4 number of children STANDARD_DEVIATION 2.0 • n=77 Households (primary caregivers) • 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.	3.5 number of children STANDARD_DEVIATION 1.3 • n=27 Households (primary caregivers) • 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.	3.4 number of children STANDARD_DEVIATION 1.9 • n=104 Households (primary caregivers) • 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.
Household size	6.4 people STANDARD_DEVIATION 2.6 • n=77 Households (primary caregivers) • 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.	6.1 people STANDARD_DEVIATION 1.7 • n=27 Households (primary caregivers) • 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.	6.2 people STANDARD_DEVIATION 2.6 • n=104 Households (primary caregivers) • 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.
Household income less than $10,000	28 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	6 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	34 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $10,000 to $14,999	12 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	2 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	14 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $15,000 to $24,999	13 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	4 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	17 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $25,000 to $34,999	3 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	4 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	7 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $35,000 to $49,999	0 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $50,000 to $74,999	3 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	4 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	7 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income $75,000 to $99,999	3 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	4 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Household income Refused/Did not wish to answer	15 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	5 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	20 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Never	24 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	8 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	32 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Seldom	9 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	4 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	13 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Sometimes	20 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	12 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	32 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Most times	14 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	15 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Always	6 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	7 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Money for utilities Refused/Did not wish to answer	4 Households (primary caregivers) n=77 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	1 Households (primary caregivers) n=27 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.	5 Households (primary caregivers) n=104 Households (primary caregivers) • Caregivers and children from 77 households in the intervention arm, and 27 households in the control arm were enrolled.
Traditional Yup'ik Lifestyle A lot	53 Households (primary caregivers) n=77 Households (primary caregivers) • 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.	17 Households (primary caregivers) n=27 Households (primary caregivers) • 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.	70 Households (primary caregivers) n=104 Households (primary caregivers) • 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.
Traditional Yup'ik Lifestyle Sometimes	24 Households (primary caregivers) n=77 Households (primary caregivers) • 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.	10 Households (primary caregivers) n=27 Households (primary caregivers) • 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.	34 Households (primary caregivers) n=104 Households (primary caregivers) • 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.
Traditional Yup'ik Lifestyle Rarely	0 Households (primary caregivers) n=77 Households (primary caregivers) • 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.	0 Households (primary caregivers) n=27 Households (primary caregivers) • 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.	0 Households (primary caregivers) n=104 Households (primary caregivers) • 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.
Traditional Yup'ik Lifestyle Never	0 Households (primary caregivers) n=77 Households (primary caregivers) • 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.	0 Households (primary caregivers) n=27 Households (primary caregivers) • 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.	0 Households (primary caregivers) n=104 Households (primary caregivers) • 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.