A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029517
• Other study ID #: I 810620
• Secondary ID: R56NR019498
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: July 20, 2024

Study information

• Verified date: December 2023
• Source: Roswell Park Cancer Institute
• Contact: Rodney Haring
• Phone: 719-845-4920
• Email: Rodney.Haring[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Education Intervention
Receive Indigneous SIPin intervention
• Interview
Complete interviews

Procedure:
• Discussion
Attend focus groups

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sugar sweetened beverage intake	change in consumption of sugar sweetened beverages	Baseline to 6 months
Secondary	Change in body weight		baseline to 6 months