Diabetes Mellitus, Type 2NCT05726409
Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes
A study testing Mobile application in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre Diabetes
- What is being tested?
- Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Being tested
- Mobile application
- Keywords
- Mobile application, Meal preparations, Recipes
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
Participants will use the meal planner function on the mobile application to plan and cook at least 3 meals a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application user | Experimental | Each participant will be sent an email with a link to download a mobile application to access the meal planner function. Receives: Other: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of mobile app use
Data will be collected by the mobile app on the frequency of use throughout the 12 week intervention.
Measured: 12 weeks
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.
Measured: 12 weeks
Satisfaction with the mobile application
An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: baseline, 12 weeks
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.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: This study was never started due to lack of access to our proposed patient database.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center Food Kitchen
- Responsible party
- Sponsor
- Investigators
- Lauren Ciszak, MD, Principal investigator, Boston Medical Center, Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726409
- Sponsor's protocol ID
- H-42380
- Status last verified
- Sep 2023
- First submitted
- 5 Feb 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT05726409
- Acronym / sponsor ID
- H-42380
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Keywords
- Mobile application, Meal preparations, Recipes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never started due to lack of access to our proposed patient database.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center Food Kitchen
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application user | Experimental | Other: Mobile applicationEach participant will be sent an email with a link to download a mobile application to access the meal planner function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationParticipants will use the meal planner function on the mobile application to plan and cook at least 3 meals a week for 12 weeks. | Other | Mobile application user |
Primary outcome
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.
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.
Satisfaction with the mobile application
Time frame: 12 weeks
An investigator developed satisfaction questionnaire will be used to assess satisfaction with the mobile application.
2 secondary outcomes
Change in dietary patterns
Time frame: baseline, 12 weeks
Change in nutrition knowledge
Time frame: baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Ciszak, MD principal investigator
Boston Medical Center, Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of mobile app use (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.