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
NCT number | NCT05726409 |
Other study ID # | H-42380 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2023 |
Est. completion date | March 2024 |
Verified date | September 2023 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Boston Medical Center Food Kitchen |
United States,
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 |
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