NCT05726409

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

February 5, 2023

Last Update Submit

September 11, 2023

Conditions

Diabetes Mellitus, Type 2Pre Diabetes

Keywords

Mobile applicationMeal preparationsRecipes

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Satisfaction with the mobile application

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

    12 weeks

Secondary Outcomes (2)

  • Change in dietary patterns

    baseline, 12 weeks

  • Change in nutrition knowledge

    baseline, 12 weeks

Study Arms (1)

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.

Other: Mobile application

Interventions

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.

Mobile application user

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Lauren Ciszak, MD

    Boston Medical Center, Department of Family Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 13, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)