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

Primary Purpose

Diabetes Mellitus, Type 2, Pre Diabetes

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile application
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Mobile application, Meal preparations, Recipes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile application user

Arm Description

Each participant will be sent an email with a link to download a mobile application to access the meal planner function.

Outcomes

Primary Outcome Measures

Frequency of mobile app use
Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.
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.
Satisfaction with the mobile application
An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 5, 2023
Last Updated
September 11, 2023
Sponsor
Boston Medical Center
Collaborators
Boston Medical Center Food Kitchen
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1. Study Identification

Unique Protocol Identification Number
NCT05726409
Brief Title
Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes
Official Title
Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
This study was never started due to lack of access to our proposed patient database.
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
Boston Medical Center Food Kitchen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Pre Diabetes
Keywords
Mobile application, Meal preparations, Recipes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application user
Arm Type
Experimental
Arm Description
Each participant will be sent an email with a link to download a mobile application to access the meal planner function.
Intervention Type
Other
Intervention Name(s)
Mobile application
Intervention Description
Participants will use the meal planner function on the mobile application to plan and cook at least 3 meals a week for 12 weeks.
Primary Outcome Measure Information:
Title
Frequency of mobile app use
Description
Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.
Time Frame
12 weeks
Title
Recipe completion rate
Description
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.
Time Frame
12 weeks
Title
Satisfaction with the mobile application
Description
An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in dietary patterns
Description
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.
Time Frame
baseline, 12 weeks
Title
Change in nutrition knowledge
Description
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.
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Ciszak, MD
Organizational Affiliation
Boston Medical Center, Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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