What side effects are associated with this type of intervention?

Lifestyle interventions for diabetes management, such as those promoted by the EML Program, generally have minimal side effects. Potential issues include hypoglycemia, particularly when combined with glucose-lowering medications, and musculoskeletal injuries from increased physical activity. Significant dietary changes may also cause gastrointestinal discomfort or nutritional deficiencies if not well-balanced.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetes that align with the goals of the Eat, Move, Live (EML) Program, which emphasizes healthy lifestyle practices, physical activity, and healthy eating. Metformin is widely recommended as a first-line therapy for type 2 diabetes due to its efficacy and safety profile. Additionally, GLP-1 agonists such as liraglutide have been approved and shown to improve glycemic control and support weight loss when combined with lifestyle interventions. These treatments complement the EML Program's focus on lifestyle modifications to manage diabetes effectively.

What other types of research exist?

Promising alternatives to the Eat, Move, Live (EML) Program for diabetes patients include: 1) GlycoLeap, a mobile lifestyle management program that includes online lessons and a mobile app to support healthy lifestyle changes and has shown potential effectiveness and feasibility in a study with Type 2 Diabetes patients. 2) ONBOARD, a telehealth-based continuous glucose monitoring adoption intervention for adults with Type 1 Diabetes, which has shown preliminary evidence of feasibility, acceptability, and efficacy in optimizing CGM use and alleviating diabetes distress.

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Behavioral Intervention for Chronic Disease Prevention

N/A

Waitlist Available

Led By Victoria L Seewaldt

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the EML Program, which offers free classes on healthy eating and physical activity to underserved communities. The goal is to help participants make better lifestyle choices and reduce their risk of chronic diseases.

Who is the study for?

The Eat, Move, Live Program is for adults over 18 from underserved communities who can speak and understand English or Spanish. It's designed to help reduce cancer and chronic disease risk by teaching healthy lifestyle habits. Participants must be able to engage in physical activity and agree to group consent.

What is being tested?

This trial tests the EML Program's effectiveness in promoting better nutrition and increasing physical activity. The program includes culturally tailored educational sessions on diet, exercise, food label reading, recipe modification, budget-friendly healthy eating, and chronic disease prevention.

What are the potential side effects?

Since this is a behavioral intervention focusing on education about nutrition and physical activity without medical treatments or drugs involved, there are no direct side effects like those seen with medication. However, changes in diet or exercise might cause discomfort initially.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12

Changes in behavior as measured by questionnaires from baseline to week 12

Changes in biomarkers

+12 more

Side effects data

From 2020 Phase 3 trial • 177 Patients • NCT01817075

13%

Rash maculo-papular

10%

Skin and subcutaneous tissue disorders - Other, specify

Mucositis oral

Sepsis

Skin ulceration

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CHG Cleansing Wipe)

Arm II (Control)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (EML program)Experimental Treatment2 Interventions

Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for diabetes, particularly those similar to the Eat, Move, Live (EML) Program, focus on lifestyle modifications such as healthy eating, increased physical activity, and overall lifestyle improvements. These interventions work by enhancing insulin sensitivity, reducing blood glucose levels, and promoting weight loss. Healthy eating helps regulate blood sugar levels by providing balanced nutrition and avoiding high-glycemic foods. Physical activity increases glucose uptake by muscles, improving insulin sensitivity and aiding in weight management. These mechanisms are crucial for diabetes patients as they help manage blood sugar levels, reduce the risk of complications, and improve overall health and quality of life.

Multicomponent approaches to promoting healthy behaviours in people with Type 2 diabetes: an integrative review.Effectiveness of a self-management support program for type 2 diabetes patients in the first years of illness: Results from a randomized controlled trial.The Rising Cost of Diabetes: Can DiRECT Tip the Scales?