Trial Outcomes & Findings for A Sugar-Sweetened Beverage Reduction Intervention for Native American Men (NCT NCT06029517)
NCT ID: NCT06029517
Last Updated: 2026-07-28
Results Overview
Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities
COMPLETED
NA
48 participants
up to 6 months
2026-07-28
Participant Flow
A total of 48 men were recruited over seven months from July 2022-February 2023.
Only qualitative data was collected from participants in Aim 1 for the purpose of culturally adapting the intervention. The qualitative data analysis generated themes and codes rather than prespecified quantitative outcome measures or statistical comparisons. Therefore, this group was not included.
Participant milestones
| Measure |
Arm 1 - Indigenous SIPin
Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.
|
Arm 2 - Indigenous SIPin Feedback Group
Participants observe the Indigenous SIPin Intervention over 6 months. Participants provide qualitative feedback data.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
18
|
|
Overall Study
COMPLETED
|
10
|
18
|
|
Overall Study
NOT COMPLETED
|
20
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Sugar Sweet Beverage (SSB) intake was only measured in Arm 1 participants. Arm 2 participants were not included in the analysis of primary and secondary endpoints because they only provided qualitative feedback data. Endpoint data was not collected for this group.
Baseline characteristics by cohort
| Measure |
Arm 1 - Indigenous SIPin
n=30 Participants
Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.
|
Arm 2 - Indigenous SIPin Feedback Group
n=18 Participants
Participants observe the Indigenous SIPin Intervention over 6 months. Participants provide qualitative feedback data.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.1 year
STANDARD_DEVIATION 9.1 • n=30 Participants
|
27.6 year
STANDARD_DEVIATION 5.1 • n=18 Participants
|
30.4 year
STANDARD_DEVIATION 8.1 • n=48 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=30 Participants
|
18 Participants
n=18 Participants
|
48 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
5 Participants
n=30 Participants
|
15 Participants
n=18 Participants
|
20 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
22 Participants
n=30 Participants
|
3 Participants
n=18 Participants
|
25 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=30 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=48 Participants
|
|
SSB intake
|
184 kcal per day
n=30 Participants • The Sugar Sweet Beverage (SSB) intake was only measured in Arm 1 participants. Arm 2 participants were not included in the analysis of primary and secondary endpoints because they only provided qualitative feedback data. Endpoint data was not collected for this group.
|
—
|
184 kcal per day
n=30 Participants • The Sugar Sweet Beverage (SSB) intake was only measured in Arm 1 participants. Arm 2 participants were not included in the analysis of primary and secondary endpoints because they only provided qualitative feedback data. Endpoint data was not collected for this group.
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: Only patients in Arm 1 are included in the primary analysis. Arm 2 participants are not included because they only provided qualitative feedback data. Endpoint data was not collected for this group.
Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities
Outcome measures
| Measure |
Arm 1 - Indigenous SIPin
n=30 Participants
Participants receive the Indigenous SIPin intervention over 6 months, which includes in-person and/or virtual educational sessions weekly over 30 minutes for 12 weeks and text message communications BIW for 12 weeks and then monthly thereafter up to month 6.
|
|---|---|
|
Change in SSB Intake for Men Affiliated With Native American Athletic Communities
|
0.18 kcal per day
Standard Error 87.31
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: No participants were analyzed for this outcome. Secondary endpoint data on dietary intake were not collected because the required assessments were not feasible within the study's operational time constraints. The endpoints required more assessment time than was available during the pre-intervention period. Many participants had work, family, and community obligations and preferred to prioritize participation in the intervention rather than complete additional research assessments.
Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 6 monthsPopulation: No participants were analyzed for this outcome. Secondary endpoint data on body weight were not collected because the required assessments were not feasible within the study's operational time constraints. The endpoints required more assessment time than was available during the pre-intervention period. Many participants had work, family, and community obligations and preferred to prioritize participation in the intervention rather than complete additional research assessments.
Change in body weight between baseline and 6 months follow-up for men affiliated with Native American athletic communities
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Indigenous SIPin
Arm 2 - Indigenous SIPin Feedback Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place