80 Participants NeededMy employer runs this trial

Fiber mHealth Intervention for Prediabetes

(GO-FAR Trial)

AB
Overseen ByAshlea Braun, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals with prediabetes by combining three elements: education about high-fiber foods, home delivery of these foods, and continuous blood sugar monitoring devices. A mobile phone app called GO-FAR manages these components, simplifying healthier eating. Young adults with prediabetes living near Tulsa who own a smartphone may find this trial suitable. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance prediabetes management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using glucagon-like peptide-1 receptor agonists.

What prior data suggests that this mHealth intervention is safe for prediabetes?

Research has shown that consuming a lot of fiber can help control blood sugar and lower high insulin levels in people with type 2 diabetes. Fiber is generally safe and typically does not cause serious side effects. The GO-FAR trial includes education about fiber, provision of high-fiber foods, and the use of devices to monitor blood sugar, emphasizing a safe and natural dietary approach.

Although mobile health (mHealth) tools for prediabetes have not proven effective for everyone, studies indicate these methods can aid in weight loss. They are generally safe, with no major safety issues reported.

Overall, the GO-FAR trial employs safe methods like fiber and mHealth, which offer known benefits and minimal risks.12345

Why are researchers excited about this trial?

Unlike traditional prediabetes treatments that often rely on medication or standard dietary advice, the GO-FAR intervention stands out with its unique approach. It delivers personalized content about fiber directly to your mobile phone daily, encouraging better dietary habits. Additionally, it includes the use of continuous glucose monitors, allowing for real-time feedback on blood sugar levels, and provides home-delivered high-fiber foods, making it easier to maintain a healthy diet. Researchers are excited because this innovative combination of technology and nutrition could offer a more accessible and engaging way to manage prediabetes.

What evidence suggests that this mHealth intervention is effective for prediabetes?

Studies have shown that a high-fiber diet can help control blood sugar levels, which is crucial for individuals with prediabetes. Research indicates that lifestyle changes, such as dietary improvements, can prevent prediabetes from progressing to type 2 diabetes. This trial will test a fiber-focused intervention using mobile health apps to guide diet. While this approach looks promising, more research is needed to determine its effectiveness specifically for prediabetes. Participants in this trial will receive mobile phone-delivered content about fiber, use continuous glucose monitors, and have high-fiber foods delivered to their homes. Early findings suggest that using devices to monitor blood sugar and receiving dietary advice can help manage blood sugar levels. Combining these methods with home-delivered high-fiber foods might enhance success in managing prediabetes.15678

Who Is on the Research Team?

AB

Ashlea Braun, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for English-speaking young adults (18-39 years old) living near Tulsa who have prediabetes based on blood tests and can use a compatible smartphone.

Inclusion Criteria

* Reside near Tulsa metro area
* Proficient in English
I am between 18 and 39 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline data collection in person to assess insulin resistance using venous blood samples

1 week
1 visit (in-person)

Treatment

Participants undergo a three-month mHealth-based intervention focused on promoting greater fiber intake, including weekly home-delivered high fiber foods and use of continuous glucose monitors

12 weeks
Continuous monitoring (remote)

Post-Intervention Assessment

Participants return for repeat assessment of insulin resistance after the intervention

1 week
1 visit (in-person)

Observation

Participants undergo a one-month observation period using cell phone-based ecological momentary assessments

4 weeks

Follow-up

Participants are monitored for retention and acceptability of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GO-FAR

Trial Overview

The study is testing if an app-based program that provides high-fiber nutrition education, home delivery of high-fiber foods, and continuous glucose monitoring is practical and helpful for people with prediabetes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Fiber-focused interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Citations

NCT07491653 | Fiber mHealth Intervention for Prediabetes

This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber foods, ...

The Use of Mobile Health Interventions for Outcomes among ...

The use of mobile health was not sufficiently proven to be effective for middle-aged and elderly patients with prediabetes.

Efficacy of exercise-based interventions for prediabetes

Our results demonstrated that exercise-based interventions significantly improve all glycaemic control parameters (glycosylated haemoglobin, fasting blood ...

Effectiveness of Smartphone Application‐Based ...

A previous systematic review and meta-analysis, which assessed the effectiveness of app-based interventions in populations with prediabetes, ...

PDM: Prediabetes (2013)

Research Purpose: To test whether counseling from a dietitian and a physiotherapist would result in improvements in diet or aerobic physical activity, ...

Fiber mHealth Intervention for Prediabetes (GO-FAR Trial)

This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber ...

Efficacy of FiberMore, an AI-Based mHealth Intervention to ...

A high intake of dietary fiber has been shown to improve glycemic control and decrease hyperinsulinemia in people living with type 2 diabetes ( ...

Fiber mHealth Intervention for Prediabetes | NCT07491653

This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber ...