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Healthy Eating Interventions for Chronic Disease Management

N/A

Waitlist Available

Led By Elliot B Davidson, MD, FAAFP

Research Sponsored by Akron General 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 from baseline visit (w1) to 16 week visit and at 6 months and 12 months from baseline

Awards & highlights

Study Summary

This trial will test the effects of two different approaches to healthy eating on weight, blood pressure, and blood sugar levels.

Who is the study for?

This trial is for adults over 18 with chronic conditions like pre-diabetes, type 2 diabetes, obesity (BMI of 30 or higher), and high blood pressure. They must be patients at Akron General Center for Family Medicine and not currently in nutrition counseling or a weight loss program. Pregnant individuals, those without internet access, needing English interpretation, or with food allergies cannot participate.Check my eligibility

What is being tested?

The study is testing the impact of medically-tailored meals versus produce boxes with recipes on health outcomes such as body weight, blood pressure, and average blood sugar levels in people with chronic diseases at Cleveland Clinic Akron General.See study design

What are the potential side effects?

Since this trial involves healthy foods and nutrition education rather than medication, side effects are minimal but may include dietary changes discomforts such as bloating or gas initially when adjusting to new eating habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline visit (w1) to 16 week visit and at 6 months and 12 months from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline visit (w1) to 16 week visit and at 6 months and 12 months from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline visit (w1) to 16 week visit and at 6 months and 12 months from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in participants' body weight

Secondary outcome measures

Hypertension: Change in medication dosage

Hypertension: Change in number of medications

Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Produce Box and RecipesExperimental Treatment1 Intervention

Weekly produce box delivered to participants' homes and access to recipes via the internet for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.

Group II: Medically-Tailored Meals (MTM)Experimental Treatment1 Intervention

Medically-tailored meals delivered to participants' homes for 15 weeks AND one medical nutrition therapy session with a dietician + viewership of 2 to 4 nutrition education videos.

Group III: Standard of CareActive Control1 Intervention

Matched controls from the same base population as participants in the intervention arms. Controls will identified from the electronic medical record (EMR).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Akron General Medical CenterLead Sponsor

6 Previous Clinical Trials

208 Total Patients Enrolled

Cleveland Clinic Akron GeneralLead Sponsor

7 Previous Clinical Trials

412 Total Patients Enrolled

The University of AkronOTHER

9 Previous Clinical Trials

815 Total Patients Enrolled

Media Library

Medically-tailored meals Clinical Trial Eligibility Overview. Trial Name: NCT05174078 — N/A

Type 2 Diabetes Research Study Groups: Medically-Tailored Meals (MTM), Produce Box and Recipes, Standard of Care

Type 2 Diabetes Clinical Trial 2023: Medically-tailored meals Highlights & Side Effects. Trial Name: NCT05174078 — N/A

Medically-tailored meals 2023 Treatment Timeline for Medical Study. Trial Name: NCT05174078 — N/A

Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05174078 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to join this research endeavor?

"As indicated in the clinicaltrials.gov listing, this clinical trial is no longer recruiting patients; it started on February 1st 2022 and was last updated September 29th of that same year. Nevertheless, there are over two-thousand nine hundred ninety trials searching for participants at present."

Answered by AI