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Behavioural Intervention

Sugar-Sweetened Beverage Reduction Program for Diabetes

N/A

Recruiting

Led By Rodney Haring

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial develops an educational program to reduce sugary drink consumption in Native American men, which can help reduce risk of chronic diseases like obesity, diabetes, and heart disease.

Who is the study for?

This trial is for Native American men aged 18 or older who are not living on tribal lands but are involved with Native organizations off-territory. They must own a smart device to receive study text messages.

What is being tested?

The Indigenous SIPin program, which includes interviews, educational interventions, and discussions aimed at reducing sugar-sweetened beverage intake among participants to lower the risk of chronic diseases like diabetes and heart disease.

What are the potential side effects?

Since this intervention involves education and lifestyle changes rather than medication, there are no direct medical side effects. However, participants may experience challenges in adjusting their diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Sugar sweetened beverage intake

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Aim 2 - Indigenous SIPinExperimental Treatment1 Intervention

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.

Group II: Aim 1 - interview, focus groupExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Discussion

2021

N/A

~180

0 / 1Eligibility criteria met