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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06029517
Other study ID # I 810620
Secondary ID R56NR019498
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2022
Est. completion date July 20, 2024

Study information

Verified date December 2023
Source Roswell Park Cancer Institute
Contact Rodney Haring
Phone 719-845-4920
Email Rodney.Haring@roswellpark.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 20, 2024
Est. primary completion date July 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education Intervention
Receive Indigneous SIPin intervention
Interview
Complete interviews
Procedure:
Discussion
Attend focus groups

Locations

Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Sugar sweetened beverage intake change in consumption of sugar sweetened beverages Baseline to 6 months
Secondary Change in body weight baseline to 6 months
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