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Completed

NCT Number: NCT06029517

A Sugar-Sweetened Beverage Reduction Intervention for Native American Men

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

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Key information

Conditions

Cardiovascular Disorder Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Obesity-Related Malignant Neoplasm Vascular Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education Intervention

Other

Receive Indigneous SIPin intervention

Other names: Education for Intervention

Observation of Indigenous SIPin Interventon

Other

Observe SIPin intervention

Discussion

Other

Attend focus groups

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Dietary Intake

    Time frame: Baseline to 6 months

    Change in dietary intake per day between baseline and 6 months follow-up for men affiliated with Native American athletic communities

  2. Change in Body Weight

    Time frame: baseline to 6 months

    Change in body weight between baseline and 6 months follow-up for men affiliated with Native American athletic communities

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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