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出境医 / 临床实验 / Healthy Foods and Education to Treat Diabetes

Healthy Foods and Education to Treat Diabetes

Study Description
Brief Summary:
The investigators will study a program that delivers weekly community-supported agriculture shares to patients of East Baltimore Medical Center in order to increase access to healthy foods. The investigators will provide adult patients with uncontrolled diabetes with healthy foods including fresh vegetables and shelf-stable pantry items (e.g., canned beans) every week over the course of 6 weeks. The investigators will also collect demographic data and food insecurity status of participants via survey. This program will also conduct weekly cooking and nutrition classes at East Baltimore Medical Center. The investigators will conduct a survey of participants' experiences each time participants pick up a vegetable bag and at the end of the cooking classes. In addition, a focus group of participants will be held to gather qualitative data regarding the vegetable initiative.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Healthy food and Education/Cooking Classes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated to one of 2 groups: a control group or the intervention group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Farm to Clinic Vegetable Initiative at East Baltimore Medical Center
Actual Study Start Date : June 18, 2019
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Healthy food and Education/Cooking Classes
At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, healthy eating attitudes, and demographics. Every week for 6 weeks, participants will pick-up a healthy food bag (e.g. fresh vegetables) for a $3 co-pay and attend an hour-long education classes at East Baltimore Medical Center. All participants will complete a survey at healthy food bag pick-up or an education class. Surveys at bag pick-up will ascertain outcomes like vegetable consumption. Surveys at education classes will ascertain outcomes like healthy eating attitudes. At 6 weeks, all participants will complete a follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again at 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
Behavioral: Healthy food and Education/Cooking Classes
The intervention includes providing weekly seasonal produce and healthy foods to participants in addition to an education/cooking class that will be tailored to Diabetes Mellitus, Type II.

No Intervention: Control Group
At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, cooking habits, food security, healthy eating attitudes, and demographics. As a control group, participants will not partake in the healthy food bag pick-ups or cooking classes therefore they will not fill out those associated surveys. After the 6 weeks of the intervention, control participants will be given the follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again after 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
Outcome Measures
Primary Outcome Measures :
  1. Change in amount of vegetables eaten [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Self-reported number of vegetables eaten per day (e.g. 2 vegetables/day) will be obtained by the survey.

  2. Change in weight (kg) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.

  3. Change in Body mass index (kg/m^2) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR or calculated with height of record.


Secondary Outcome Measures :
  1. Change in Glycosylated Hemoglobin level (percent of mmol/mol) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR.

  2. Change in Blood pressure (mmHg) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin >8%)
  • 18 years age of and over
  • Living within the geographical region of East Baltimore Medical Campus

Exclusion Criteria:

  • Current participation in Five Plus Nuts and Beans Study or other program that provides diet-based food
  • Non-English speaking
  • On hospice or palliative care
  • Acute or chronic psychosis
  • Active substance or alcohol use disorder
  • Another active medical disorder that would preclude participation in weekly food pick-up or classes including: active treatment of cancer, steroid dependent asthma/chronic obstructive pulmonary disease/emphysema, steroid dependent colitis; chronic kidney disease with an estimated glomerular filtration rate less than 30mg/mmol, venous thromboembolic disease with current treatment with vitamin K antagonist, Celiac disease, cirrhosis or steroid dependent arthritis
Contacts and Locations

Locations
Layout table for location information
United States, Maryland
Johns Hopkins Community Physicians at East Baltimore Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Donald RB Miles, MD Johns Hopkins Community Physicians
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE June 18, 2019
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change in amount of vegetables eaten [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Self-reported number of vegetables eaten per day (e.g. 2 vegetables/day) will be obtained by the survey.
  • Change in weight (kg) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from Electronic Medical Record (EMR) or weighed at weekly bag pick-up.
  • Change in Body mass index (kg/m^2) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR or calculated with height of record.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change in Glycosylated Hemoglobin level (percent of mmol/mol) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR.
  • Change in Blood pressure (mmHg) [ Time Frame: Baseline, at 6 weeks, 10 weeks, 18 weeks and 30 weeks ]
    Recorded from EMR.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Foods and Education to Treat Diabetes
Official Title  ICMJE Farm to Clinic Vegetable Initiative at East Baltimore Medical Center
Brief Summary The investigators will study a program that delivers weekly community-supported agriculture shares to patients of East Baltimore Medical Center in order to increase access to healthy foods. The investigators will provide adult patients with uncontrolled diabetes with healthy foods including fresh vegetables and shelf-stable pantry items (e.g., canned beans) every week over the course of 6 weeks. The investigators will also collect demographic data and food insecurity status of participants via survey. This program will also conduct weekly cooking and nutrition classes at East Baltimore Medical Center. The investigators will conduct a survey of participants' experiences each time participants pick up a vegetable bag and at the end of the cooking classes. In addition, a focus group of participants will be held to gather qualitative data regarding the vegetable initiative.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated to one of 2 groups: a control group or the intervention group.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Behavioral: Healthy food and Education/Cooking Classes
The intervention includes providing weekly seasonal produce and healthy foods to participants in addition to an education/cooking class that will be tailored to Diabetes Mellitus, Type II.
Study Arms  ICMJE
  • Experimental: Healthy food and Education/Cooking Classes
    At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, healthy eating attitudes, and demographics. Every week for 6 weeks, participants will pick-up a healthy food bag (e.g. fresh vegetables) for a $3 co-pay and attend an hour-long education classes at East Baltimore Medical Center. All participants will complete a survey at healthy food bag pick-up or an education class. Surveys at bag pick-up will ascertain outcomes like vegetable consumption. Surveys at education classes will ascertain outcomes like healthy eating attitudes. At 6 weeks, all participants will complete a follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again at 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
    Intervention: Behavioral: Healthy food and Education/Cooking Classes
  • No Intervention: Control Group
    At consent, participant will complete the baseline survey. Baseline survey will collect information like vegetable consumption, cooking habits, food security, healthy eating attitudes, and demographics. As a control group, participants will not partake in the healthy food bag pick-ups or cooking classes therefore they will not fill out those associated surveys. After the 6 weeks of the intervention, control participants will be given the follow-up survey equivalent to the baseline survey. The follow-up survey will be completed again after 10 weeks, 18 weeks, and 30 weeks. Participants will also be weighed at each bag pick-up (participants may decline) and relevant health information like blood pressure will be obtained from the EMR from an associated office visit.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
50
Actual Study Completion Date  ICMJE September 26, 2019
Actual Primary Completion Date September 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with uncontrolled diabetes mellitus (defined as a glycosylated hemoglobin >8%)
  • 18 years age of and over
  • Living within the geographical region of East Baltimore Medical Campus

Exclusion Criteria:

  • Current participation in Five Plus Nuts and Beans Study or other program that provides diet-based food
  • Non-English speaking
  • On hospice or palliative care
  • Acute or chronic psychosis
  • Active substance or alcohol use disorder
  • Another active medical disorder that would preclude participation in weekly food pick-up or classes including: active treatment of cancer, steroid dependent asthma/chronic obstructive pulmonary disease/emphysema, steroid dependent colitis; chronic kidney disease with an estimated glomerular filtration rate less than 30mg/mmol, venous thromboembolic disease with current treatment with vitamin K antagonist, Celiac disease, cirrhosis or steroid dependent arthritis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991026
Other Study ID Numbers  ICMJE IRB00164545
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald RB Miles, MD Johns Hopkins Community Physicians
PRS Account Johns Hopkins University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP