Clinical trial NCT06029517: A Sugar-Sweetened Beverage Reduction Intervention for Native American Men
Official title: A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cardiovascular Disorder
Coronary Artery Disease
Diabetes Mellitus
Obesity-Related Malignant Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-09-08
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in SSB intake for men affiliated with Native American athletic communities
timeFrame: up to 6 months
Secondary outcomes:
measure: Sugar sweetened beverage intake
timeFrame: Baseline to 6 months
measure: Change in body weight
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park
name: Rodney Haring
role: PRINCIPAL_INVESTIGATOR
References: