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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05726409
• Other study ID #: H-42380
• Status: Withdrawn
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Boston Medical Center Food Kitchen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Satisfaction with the mobile application	An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.	12 weeks
Secondary	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
Secondary	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