Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes

Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes: A Pilot Study

Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity including a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established, three-pronged approach places BMC in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population.

For this first exploratory study, 75 enrolled participants will be given a free mobile application with recipes designed to build habits. Participants will cook at least three meals weekly for two months using the app. Self-reported survey data and activity on the app will be collected and used to assess the feasibility of teaching cooking skills through a mobile application.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2; Pre Diabetes
• Intervention / Treatment: Other: Mobile application

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Ciszak, MD; Phone Number: 617-425-2000; Email: ciszakl@ebnhc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
      • Contact: Lauren Ciszak, MD; Phone Number: 617-425-2000; Email: ciszakl@ebnhc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Access to an oven OR microwave, stovetop OR hot plate, and food storage.
• Access to the internet on a smartphone
• Owns a smartphone with iOS Apple Store or Google Play
• Reading proficiency in English
• Has a diagnosis of diabetes or prediabetes(Hb A1C> 5.6)

Exclusion Criteria:

• Inability to provide informed consent
• Taking any medications or has a condition that limits the ability to increase intake of fruits and vegetables (including warfarin and end-stage renal disease)
• Attended a Diabetes Self-Management Education (DSME) at BMC within the past year or plans to attend during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile application user; Each participant will be sent an email with a link to download a mobile application to access the meal planner function.	Other: Mobile application; Participants will use the meal planner function on the mobile application to plan and cook at least 3 meals a week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of mobile app use	Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.	12 weeks
Recipe completion rate	Data will be collected by the mobile app on the rate of recipe completion throughout the 12 week intervention. Higher rates of completion are considered more favorable.	12 weeks
Satisfaction with the mobile application	An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dietary patterns	This outcome will be measured using PrimeScreen, which is a validated brief dietary screening tool developed by the Harvard School of Public Health. It will provide the change in frequency of consumption of fruits, vegetables, lean protein, carbohydrates, fat, and processed foods.	baseline, 12 weeks
Change in nutrition knowledge	Change in nutrition knowledge will be assessed through the adapted Slater Nutrition Knowledge Survey. These questions apply knowledge by asking participants to use their knowledge to make decisions rather than repeating the taught nutrition recommendations.	baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Boston Medical Center Food Kitchen
• Investigators: Principal Investigator: Lauren Ciszak, MD, Boston Medical Center, Department of Family Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 5, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mobile application; Meal preparations; Recipes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: H-42380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No