Health TrialsbyHealthPanel

APP-MNT: App-Enhanced Medical Nutrition Therapy on Glycemic Outcomes and Quality of Life

ConditionDiabetes (Insulin-requiring, Type 1 or Type 2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWeill Medical College of Cornell University

About this trial

The purpose of the study is to see if using a diabetes app along with nutrition counseling from a registered dietitian nutritionist can help improve blood sugars and cholesterol levels, quality of life, physical activity, and food and beverage choices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18-75 years of age.

Documentation of a T1D or T2D diagnosis.

A1C of 6.5 or greater.

Access to a compatible smartphone.

Disqualifiers

Heart failure.

Advanced kidney disease.

Severe cognitive or psychological disabilities.

Depression.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Undermyfork Care App

    Device

    \- Intervention Group Participants assigned to the intervention group will be encouraged to use the app as frequently as they prefer (with minimum of 2 x week) for 6 months. Information that will be tracked includes food intake by photos and/or text, physical activity, glucose levels, and insulin dosing if applicable. Additional patient-generated health data to include in the app will be based on the participant's diabetes treatment plan and determined in collaboration with the RDN. The RDN will review each participants data from the Undermyfork Care as needed between visits (e.g. patient initiated question) and will message or call the participant to encourage engagement if data input is lacking. At each follow up visit, the RDN will review the participants data through Undermyfork Care to help make informed treatment recommendations and troubleshooting the use of the app if needed.

  • Usual Care

    Other intervention

    Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: MNT Usual Care (Control)Other 1 intervention
Group B: App-Enhanced MNTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in A1C at 6 Months

Time frame
Baseline-6 Months
2

Change from Baseline in Time in Range as measured by continuous glucose monitoring at 6 Months

Time frame
Baseline-6 Months
3

Change from Baseline in Diabetes Quality of Life at 6 Months as measured by the Diabetes Quality of Life Brief Clinical Inventory (DQOL-B)

The Diabetes Quality of Life Brief Clinical Inventory (DQOL-B) measures diabetes quality of life. Total scores range from 13-65, with lower scores indicating better quality of life (less impact/worry, higher satisfaction), whereas higher scores reflect higher distress/dissatisfaction.

Time frame
Baseline-6 Months
4

Change from Baseline in Diabetes Quality of Life subscale Impact at 6 Months as measured by DQoL-B subscale Impact

The Diabetes Quality of Life Brief Clinical Inventory (DQoL-B) subscale Impact measures diabetes quality of life. Total scores range from 4-20, with lower scores indicating less impact, whereas higher scores reflect more impact.

Time frame
Baseline-6 Months

Secondary outcomes

1

Change from Baseline in Physical Activity at 6 Months as measured by the Godin Leisure-Time Exercise Questionnaire

This is brief self-administered validated questionnaire measuring the number of times one engages in strenuous, moderate, and mild exercise in periods of 15-minute increment within a week. A Godin score of \>24 units= active, 14-23 units= moderately active, and \<14 units= sedentary

Time frame
Baseline-6 Months
2

Change from Baseline in Body Weight at 6 Months

Time frame
Baseline-6 Months
3

Change from Baseline in Dietary Fiber Intake at 6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, with more dietary fiber intake indicating more closely aligning with diabetes nutrition recommendation.

Time frame
Baseline-6 Months
4

Change from Baseline in Daily Average Energy Intake at 6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, for Daily Average Energy Intake for change from baseline to 6 months.

Time frame
Baseline-6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

West Chester University of Pennsylvania

Collaborator

Academy of Nutrition and Dietetics

Collaborator

Source ClinicalTrials.gov
Apply now