A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Education Intervention
* Other: Interview
* Procedure: Discussion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aim 1 - interview, focus group<br>Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement | Other: Interview<br>* Complete interviews<br>Procedure: Discussion<br>* Attend focus groups<br>|
| Experimental: Aim 2 - Indigenous SIPin<br>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<br>* Receive Indigneous SIPin intervention<br>* Other names: Education for Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |