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Behavioral Intervention

Food & Video-Based Nutrition Education for Type 2 Diabetes

N/A

Waitlist Available

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)

Be older than 18 years old

Must not have

Major communication barriers such as visual or hearing impairment that would compromise the ability to participate in a video visit

Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition [TPN])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major hearing or vision problems that would prevent me from participating in a video call.

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I do not eat by mouth and receive nutrition through a tube or IV.

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I am currently getting medical therapy management.

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I have a severe case of delayed stomach emptying.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 5Eligibility criteria met