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

Sponsor

Boston Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05726409

Collaborator

Boston Medical Center Food Kitchen (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Pre Diabetes	Other: Mobile application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in dietary patterns [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.
Change in nutrition knowledge [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.