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A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Primary Purpose

Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education Intervention
Interview
Discussion
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Roswell Park Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Aim 1 - interview, focus group

Aim 2 - Indigenous SIPin

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sugar sweetened beverage intake
change in consumption of sugar sweetened beverages
Change in body weight

Full Information

First Posted
September 1, 2023
Last Updated
September 12, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT06029517
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
October 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1 - interview, focus group
Arm Type
Other
Arm Description
Participants complete interviews over 60 minutes and attend focus groups over 90 minutes in support of intervention adaptation and refinement
Arm Title
Aim 2 - Indigenous SIPin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education Intervention
Other Intervention Name(s)
Education for Intervention
Intervention Description
Receive Indigneous SIPin intervention
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Complete interviews
Intervention Type
Procedure
Intervention Name(s)
Discussion
Intervention Description
Attend focus groups
Primary Outcome Measure Information:
Title
Change in SSB intake for men affiliated with Native American athletic communities
Description
Will conduct half hour classes with the Native American community members on how to improve wellness and drink less sugary drinks
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Sugar sweetened beverage intake
Description
change in consumption of sugar sweetened beverages
Time Frame
Baseline to 6 months
Title
Change in body weight
Time Frame
baseline to 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodney Haring
Phone
719-845-4920
Email
Rodney.Haring@roswellpark.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Haring
Organizational Affiliation
Roswell Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodney Haring

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

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