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WithdrawnNCT05726409Updated Sep 13, 2023

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

An interventional study of Mobile application in Diabetes Mellitus, Type 2 and Pre Diabetes, sponsored by Boston Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
This study was never started due to lack of access to our proposed patient database.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Pre Diabetes

Keywords

  • Mobile application
  • Meal preparations
  • Recipes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • OtherMobile 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.

06

What researchers measure

Primary outcomes

  1. Frequency of mobile app use

    Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. Satisfaction with the mobile application

    An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline, 12 weeks

  2. 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.

    Time frame: baseline, 12 weeks

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05726409
Collaborators
Boston Medical Center Food Kitchen
Responsible party
Sponsor
First posted
Feb 13, 2023
Start date
Sep 2023 (estimated)
Primary completion
Mar 2024 (estimated)
Completion
Mar 2024 (estimated)
Last update
Sep 13, 2023

Study contacts

Lauren Ciszak, MD
principal investigator · Boston Medical Center, Department of Family Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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