A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Roswell Park Comprehensive Cancer Center

Status: Suspended

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

Treatments: Other: Interview; Other: Education Intervention; Procedure: Discussion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06029517

R56NR019498 (U.S. NIH Grant/Contract)

I 810620

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Aim 1 - interview, focus group

Other group

Description:

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

Treatment:

Procedure: Discussion

Other: Interview

Aim 2 - Indigenous SIPin

Experimental group

Description:

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.

Treatment:

Other: Education Intervention