Cardiovascular DisorderNCT06029517
A Sugar-Sweetened Beverage Reduction Intervention for Native American Men
A study testing Education Intervention, Observation of Indigenous SIPin Interventon and Discussion in people with Cardiovascular Disorder and Coronary Artery Disease, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Education Intervention, Observation of Indigenous SIPin Interventon and Discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years or older
- Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
- Participants only must own a smart device in order to receive study text messages
- At least 18 years or older
- Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
- Participants only must own a smart device in order to receive study text messages
Who cannot join
- Research conducted on tribal lands require tribal government approval. Since we do not currently have tribal government approval, our project will not be occurring on tribal lands
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
About this study
Official title: A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men
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
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm
- Being tested
- Education Intervention, Observation of Indigenous SIPin Interventon, Discussion
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionOther
Also called Education for Intervention
Receive Indigneous SIPin intervention
Observation of Indigenous SIPin InterventonOther
Observe SIPin intervention
DiscussionOther
Attend focus groups
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Indigenous SIPin | Experimental | 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. Receives: Other: Education Intervention |
| Arm 2 - Indigenous SIPin Feedback group | Other | Participants observe the Indigenous SIPin Intervention over 6 months. Participants provide qualitative feedback data. Receives: Other: Observation of Indigenous SIPin Interventon; Other: Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (2)
Dietary Intake
Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities
Measured: 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
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Jul 2022
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DisorderStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Rodney Haring, Principal investigator, Roswell Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029517
- Sponsor's protocol ID
- I 810620
- Other IDs
- R56NR019498
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2023
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men
- ClinicalTrials.gov ID
- NCT06029517
- Acronym / sponsor ID
- I 810620
- Conditions
- Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Indigenous SIPin | Experimental | Other: Education InterventionParticipants 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 | Other | Other: Observation of Indigenous SIPin Interventon, Other: DiscussionParticipants observe the Indigenous SIPin Intervention over 6 months. Participants provide qualitative feedback data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years or older
- Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
- Participants only must own a smart device in order to receive study text messages
- At least 18 years or older
- Research conducted on tribal lands require tribal government approval. Our project will not be occurring on tribal lands. The project will be working with Native organizations off-territory
Key exclusion criteria (1 listed)
- Research conducted on tribal lands require tribal government approval. Since we do not currently have tribal government approval, our project will not be occurring on tribal lands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education InterventionAlso: Education for InterventionReceive Indigneous SIPin intervention | Other | Arm 1 - Indigenous SIPin |
| Observation of Indigenous SIPin InterventonObserve SIPin intervention | Other | Arm 2 - Indigenous SIPin Feedback group |
| DiscussionAttend focus groups | Other | Arm 2 - Indigenous SIPin Feedback group |
Primary outcome
Change in SSB Intake for Men Affiliated With Native American Athletic Communities
Time frame: up to 6 months
Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities
2 secondary outcomes
Dietary Intake
Time frame: Baseline to 6 months
Change in Body Weight
Time frame: baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney Haring principal investigator
Roswell Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention, Observation of Indigenous SIPin Interventon and Discussion in people with Cardiovascular Disorder and Coronary Artery Disease, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SSB Intake for Men Affiliated With Native American Athletic Communities (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.