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临床试验/NCT06029517
NCT06029517已完成不适用

A Novel Sugar-Sweetened Beverage Reduction Intervention for Native American Men

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change in SSB intake for men affiliated with Native American athletic communities

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in SSB intake for men affiliated with Native American athletic communities

时间窗: 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

Change in SSB Intake for Men Affiliated With Native American Athletic Communities

时间窗: 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

次要结局

  • Change in body weight(baseline to 6 months)
  • Sugar sweetened beverage intake(Baseline to 6 months)
  • Dietary Intake(Baseline to 6 months)
  • Change in Body Weight(baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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