A Sugar-Sweetened Beverage Reduction Intervention for Nat... | NCT06029517

Studies
A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

NCT06029517

Sponsor

Roswell Park Cancer Institute

Status

Active, not recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Cardiovascular Disorder
Coronary Artery Disease
Diabetes Mellitus
Obesity-Related Malignant Neoplasm

Interventions

Education Intervention
Interview
Discussion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R56NR019498	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Sep 15, 2025Actual

Completion Date

Sep 15, 2026Estimated

First Submitted Date

Sep 1, 2023

First Submission Date that Met QC Criteria

Sep 1, 2023

First Posted Date

Sep 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2025

Last Update Posted Date

Dec 24, 2025Actual

Name	Class
National Institute of Nursing Research (NINR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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:

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:

AIM 1: Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement.

AIM 2: 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aim 1 - interview, focus group	Other	Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement	Other: Interview Procedure: Discussion
Aim 2 - 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.	Other: Education Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education Intervention	Other	Receive Indigneous SIPin intervention	Aim 2 - Indigenous SIPin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SSB intake for men affiliated with Native American athletic communities	Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks	up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Sugar sweetened beverage intake	change in consumption of sugar sweetened beverages	Baseline to 6 months
Change in body weight		baseline to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodney Haring	Roswell Park	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Roswell Park Comprehensive Cancer Center		Buffalo	New York	14263	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 1, 2026
Reset	Jun 25, 2026

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jul 7, 2023	Nov 25, 2025	ICF_000.pdf

Submission Tracking

Estimated Results First Submitted Date

Jun 1, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 1, 2026			Jun 25, 2026
Jun 29, 2026

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018479	Early Intervention, Educational
D004522	Educational Status
D008722	Methods
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D002662	Child Health Services
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided