Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm
Conditions
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: 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. Participants observe the Indignious SIPin intervention over 6 months and provide qualitative feedback data.
Interventions
OTHEREducation Intervention
Receive Indigneous SIPin intervention
OTHERObservation of Indigenous SIPin Interventon
Observe SIPin intervention
OTHERDiscussion
Attend focus groups
Sponsors
Roswell Park Cancer Institute
National Institute of Nursing Research (NINR)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SSB Intake for Men Affiliated With Native American Athletic Communities | up to 6 months | Change in Sugar Sweet Beverage (SSB) intake per day from baseline to 6 months follow-up for men affiliated with Native American athletic communities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Intake | Baseline to 6 months | Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities |
| Change in Body Weight | baseline to 6 months | Change in body weight between baseline and 6 months follow-up for men affiliated with Native American athletic communities |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRodney Haring
Roswell Park
Participant flow
Recruitment details
A total of 48 men were recruited over seven months from July 2022-February 2023.
Pre-assignment details
Only qualitative data was collected from participants in Aim 1 for the purpose of culturally adapting the intervention. The qualitative data analysis generated themes and codes rather than prespecified quantitative outcome measures or statistical comparisons. Therefore, this group was not included.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.4 year STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized American Indian | 22 Participants |
| Race/Ethnicity, Customized Caucasian/White | 20 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
| SSB intake | 184 kcal per day |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 18 |
| other Total, other adverse events | 0 / 30 | 0 / 18 |
| serious Total, serious adverse events | 0 / 30 | 0 / 18 |
Outcome results
None listed