← Back to Search

Behavioral Intervention

Food & Video-Based Nutrition Education for Type 2 Diabetes

N/A
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have type 2 diabetes mellitus (DM)
Are 18 years or older of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will compare how well two different methods - medically tailored meals and medical nutrition therapy via telehealth - help patients with poorly controlled type 2 diabetes. The goal is to see if these interventions can improve outcomes by impacting self-care behaviors and diet self-efficacy.

Who is the study for?
This trial is for adults over 18 with poorly controlled type 2 diabetes (HbA1c >8%), who speak English, have a device for video visits, can store and reheat food, live in the MANNA service area, and are not pregnant or breastfeeding. Excluded are those with life expectancy under one year, severe dietary restrictions or psychiatric conditions that affect participation.Check my eligibility
What is being tested?
Project MiNT tests if medically tailored meals and telehealth nutrition therapy improve diabetes control. Participants will be randomly assigned to receive these interventions or standard care to see which helps more with self-care behaviors and diet efficacy.See study design
What are the potential side effects?
There may not be direct side effects from the interventions as they involve receiving specialized meals and nutritional education rather than medication. However, changes in diet could potentially cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes.
Select...
I am 18 years old or older.
Select...
I have access to an email account.
Select...
I have type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in diabetes quality of life for patients with poorly controlled type 2 diabetes mellitus as measured by Diabetes Quality of Life (DQoL) instrument
Change in diabetes self-efficacy for patients with poorly controlled type 2 diabetes mellitus as measured by The Diabetes Self Efficacy Scale
Body Weight Changes
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meals (MTM)Experimental Treatment1 Intervention
Participants in this arm will receive MTM for 12 weeks. Meals will be prepared and delivered by MANNA, a non-profit organization that has provided MTM for patients with chronic illnesses in Philadelphia and Southern New Jersey since 1990. MANNA will deliver 21 complete meals to the patient's home each week, providing 45-60 grams of carbohydrates per meal for optimal glucose control based on ADA guidelines and 100% of overall nutritional requirements based on USDA guidelines. In addition, children and any senior dependents for whom the participant is the primary caregiver will receive meals for the entire 12 weeks for no additional cost, as this is standard of care of MANNA services. MANNA registered dieticians will cater the program to meet the specific needs (e.g., dietary restrictions, cultural preferences). Investigators will provide information on community resources in the area, including food resources, for all patients.
Group II: MTM + tele-Medical Nutrition Therapy (MNT)Experimental Treatment2 Interventions
Patients in this arm will receive MTM services as well as tele-MNT over 12 months. The tele-MNT intervention will be delivered by a registered dietician within the Jefferson endocrine clinic, with assistance by other endocrine dieticians and fellows. In the first months, video visits focus on supporting individuals who are not selecting, preparing or purchasing their own meals. As the end of MTM services approaches, the intervention shifts to focus on the transition from MTM to self-directed eating. Based on Academy of Nutrition and Dietetics recommendations, each participant's MNT will include the following core features: nutrition assessment, intervention, care coordination, monitoring and evaluation. The following will also be addressed: nutrition prescriptions, nutrient intake, energy intake, glycemic index and load, alcohol consumption and physical activity. The schedule includes individual visits in the first 6 months and monthly group session in months 7-12.
Group III: Usual CareActive Control1 Intervention
Patients in this arm will receive usual services offered at Jefferson for patients with DM, which includes regular visits with a diabetes provider (primary care or endocrine), standard ADA information pamphlets and referral to 1) diabetes education classes and 2) nutrition counseling by dieticians and nurse practitioners. During routine office visits, providers reinforce messages about self-management and provide lists of local and national resources related to nutrition and diabetes self-management (e.g., diabetes.org). The standard of care at Jefferson for patients with DM is to begin with a single group MNT visit lasting from 60-90 minutes. Each participant's need for additional sessions and general time-frame for follow-up is individually determined following the group session, based on patient preference. Historically, only about 2% of the Jefferson population engages in these services, thus minimizing dilution of the effect of the tele-MNT.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
443 Previous Clinical Trials
144,900 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,803,499 Total Patients Enrolled
West Chester University of PennsylvaniaOTHER
5 Previous Clinical Trials
824 Total Patients Enrolled

Media Library

Medically Tailored Meals (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04264572 — N/A
Type 2 Diabetes Research Study Groups: Medically Tailored Meals (MTM), MTM + tele-Medical Nutrition Therapy (MNT), Usual Care
Type 2 Diabetes Clinical Trial 2023: Medically Tailored Meals Highlights & Side Effects. Trial Name: NCT04264572 — N/A
Medically Tailored Meals (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04264572 — N/A

Frequently Asked Questions

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

What is the scale of this experiment regarding participant numbers?

"Affirmative. Per the info on clinicaltrials.gov, this medical research is currently enrolling participants. It was first posted to their website in January 2021, with its most current update occurring May 3rd of this year. This experiment requires 600 individuals from a single clinic site."

Answered by AI

Is there an ongoing recruitment process for this medical experiment?

"Affirmative. Clinicaltrials.gov reports that this clinical trial, first announced on January 21st 2020 , is actively searching for participants. The study requires 600 patients from one location to complete the enrollment process."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m interested in what your doing. Because I want to keep my A1C down.
PatientReceived 2+ prior treatments
~44 spots leftby Jul 2024