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A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT06029517
Collaborator
National Institute of Nursing Research (NINR) (NIH)
100
Enrollment
1
Location
2
Arms
33.5
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Education Intervention
  • Other: Interview
  • Procedure: Discussion
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men
Actual Study Start Date :
Jan 8, 2021
Anticipated Primary Completion Date :
Oct 25, 2023
Anticipated Study Completion Date :
Oct 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Aim 1 - interview, focus group

Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement

Other: Interview
Complete interviews

Procedure: Discussion
Attend focus groups
Experimental: Aim 2 - Indigenous SIPin

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
Receive Indigneous SIPin intervention
Other Names:
  • Education for Intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Sugar sweetened beverage intake [Baseline to 6 months]

      change in consumption of sugar sweetened beverages

    2. Change in body weight [baseline to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Comprehensive Cancer Center Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute
    • National Institute of Nursing Research (NINR)

    Investigators

    • Principal Investigator: Rodney Haring, Roswell Park

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT06029517
    Other Study ID Numbers:
    • I 810620
    • R56NR019498
    First Posted:
    Sep 8, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Coronary Artery Disease
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Sep 14, 2023