A Sugar-Sweetened Beverage Reduction Intervention for Native American Men
- Conditions
- Coronary Artery DiseaseDiabetes MellitusCardiovascular DisorderObesity-Related Malignant Neoplasm
- Interventions
- Other: Education InterventionOther: InterviewProcedure: Discussion
- Registration Number
- NCT06029517
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aim 2 - Indigenous SIPin Education Intervention 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. Aim 1 - interview, focus group Interview Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement Aim 1 - interview, focus group Discussion Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement
- Primary Outcome Measures
Name Time Method Change in SSB intake for men affiliated with Native American athletic communities up to 6 months Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks
- Secondary Outcome Measures
Name Time Method Sugar sweetened beverage intake Baseline to 6 months change in consumption of sugar sweetened beverages
Change in body weight baseline to 6 months
Trial Locations
- Locations (1)
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States