A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

NCT06029517 | Active Not Recruiting

• 2 other identifiers: I 810620R56NR019498
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Sugar sweetened beverage intake

  Baseline to 6 months

• Change in body weight

  baseline to 6 months

Study Arms (2)

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

Education Intervention OTHER

Receive Indigneous SIPin intervention

Also known as: Education for Intervention

Aim 2 - Indigenous SIPin

Interview OTHER

Complete interviews

Aim 1 - interview, focus group

Discussion PROCEDURE

Attend focus groups

Aim 1 - interview, focus group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Diabetes Mellitus

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rodney Haring

  Roswell Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: July 20, 2022
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)