An interventional study of Education Intervention and Observation of Indigenous SIPin Interventon in Cardiovascular Disorder, Coronary Artery Disease and Diabetes Mellitus, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Prevention
This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice. Increased sugar consumption may lead to an increased risk of chronic diseases, including obesity, diabetes, some types of obesity-related cancers, coronary heart disease, hypertension, and dental decay. A culturally sensitive program may help reduce sugar-sweetened beverage consumption in Native American men
PRIMARY OBJECTIVE:
I. Conduct and analyze qualitative data from focus groups and key informant interviews with Native American community members including Native American leaders and community members to develop Sugar Sweetened Beverage (SSB) intervention for Native American men (SIPsmartER Lacrosse).
OUTLINE:
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 twice a week (BIW) for 12 weeks and then monthly thereafter up to month 6. Participants observe the Indignious SIPin intervention over 6 months and provide qualitative feedback data.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 48 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Education Intervention
Participants observe the Indigenous SIPin Intervention over 6 months. Participants provide qualitative feedback data.
Other: Observation of Indigenous SIPin Interventon · Other: Discussion
Receive Indigneous SIPin intervention
Also known as: Education for Intervention
Observe SIPin intervention
Attend focus groups
Change in SSB Intake for Men Affiliated With Native American Athletic Communities
Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities
Time frame: up to 6 months
Dietary Intake
Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities
Time frame: Baseline to 6 months
Change in Body Weight
Change in body weight between baseline and 6 months follow-up for men affiliated with Native American athletic communities
Time frame: baseline to 6 months
A total of 48 men were recruited over seven months from July 2022-February 2023.
| Milestone | Arm 1 - Indigenous SIPin | Arm 2 - Indigenous SIPin Feedback Group |
|---|---|---|
| Started | 30 | 18 |
| Completed | 10 | 18 |
| Not completed | 20 | 0 |
Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities
| kcal per day | Arm 1 - Indigenous SIPin |
|---|---|
| Change in SSB Intake for Men Affiliated With Native American Athletic Communities | 0.18 ± 87.31 |
Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities
No measurements were reported for this outcome.
Change in body weight between baseline and 6 months follow-up for men affiliated with Native American athletic communities
No measurements were reported for this outcome.
Collected over from enrollment until end of follow-up, up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 - Indigenous SIPin | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Arm 2 - Indigenous SIPin Feedback Group | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(year) | Arm 1 - Indigenous SIPin | Arm 2 - Indigenous SIPin Feedback Group | Total |
|---|---|---|---|
| Mean | 32.1 ± 9.1 | 27.6 ± 5.1 | 30.4 ± 8.1 |
| Sex: Female, Male(Participants) | Arm 1 - Indigenous SIPin | Arm 2 - Indigenous SIPin Feedback Group | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 30 | 18 | 48 |
| Race/Ethnicity, Customized(Participants) | Arm 1 - Indigenous SIPin | Arm 2 - Indigenous SIPin Feedback Group | Total |
|---|---|---|---|
| Caucasian/White | 5 | 15 | 20 |
| American Indian | 22 | 3 | 25 |
| Other | 3 | 0 | 3 |
| SSB intake(kcal per day) | Arm 1 - Indigenous SIPin | Arm 2 - Indigenous SIPin Feedback Group | Total |
|---|---|---|---|
| Median | 184 (76 to 541) | — | 184 (76 to 541) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Roswell Park Cancer Institute