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

September 11, 2023 updated by: Boston Medical Center

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 weeks
Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.
12 weeks
Recipe completion rate
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: baseline, 12 weeks
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
Time Frame: baseline, 12 weeks
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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