NCT02548299

Brief Summary

This study is a multi-dimensional therapeutic lifestyle program that offers cooking and nutrition education as well as email-based health coaching to diabetic patients in an underserved Cleveland community. This is an innovative project as it is one of the first focused efforts within this community to improve diabetes control and prevent diabetes progression through cooking and nutrition as well as to systematically measure both clinical and behavioral outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable diabetes

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

September 4, 2015

Last Update Submit

May 6, 2022

Conditions

Keywords

DiabetesCookingNutritionLifestyle Medicine

Outcome Measures

Primary Outcomes (2)

  • Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 8 weeks

    Responses to individual questions will be tracked throughout the intervention in order to evaluate basic cooking skills and knowledge of nutrition that can be used to prepare healthy meals and follow recipes.

    8 weeks

  • Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 6 months

    Responses to individual questions will be tracked throughout the intervention in order to evaluate basic cooking skills and knowledge of nutrition that can be used to prepare healthy meals and follow recipes.

    6 months

Secondary Outcomes (22)

  • Height (centimeters) - Change from Baseline to 8 weeks

    8 weeks

  • Height (centimeters) - Change from Baseline to 6 months

    6 months

  • Weight (kilograms) - Change from Baseline to 8 weeks

    8 weeks

  • Weight (kilograms) - Change from Baseline to 6 months

    6 months

  • Fasting Blood Glucose (mg/dL) - Change from Baseline to 8 weeks

    8 weeks

  • +17 more secondary outcomes

Study Arms (3)

Cooking Lecture

EXPERIMENTAL

Participants in this arm will receive cooking education through lecture/PowerPoint presentation led by our executive chef. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.

Other: Nutrition EducationOther: Cooking LectureOther: e-Coaching

Cooking Demo

EXPERIMENTAL

Participants in this arm will receive cooking education through observation of our executive chef who will explain cooking techniques and healthy food preparation practices as he cooks a healthy recipe(s) for participants to sample. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.

Other: Nutrition EducationOther: Cooking DemoOther: e-Coaching

Hands-on Cooking

EXPERIMENTAL

Participants in this arm will receive cooking education through hands on practical experience with our executive chef in a teaching kitchen. Participants will be able to sample what they prepare. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.

Other: Nutrition EducationOther: Hands-on CookingOther: e-Coaching

Interventions

Nutrition classes will be led by a registered dietician.

Cooking DemoCooking LectureHands-on Cooking
Cooking Lecture
Cooking Demo
Hands-on Cooking
Cooking DemoCooking LectureHands-on Cooking

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Current State of Ohio Medicaid recipient
  • Current diagnosis of diabetes, as reported in the electronic medical record
  • Completed at least one diabetes education visit at STJHC
  • Have daily access to a functional kitchen in home

You may not qualify if:

  • Pregnancy or lactation or plans to be pregnant or lactate during study
  • Current alcoholism or abuse of recreational drugs
  • Self-reported or history of HIV or hepatitis or active tuberculosis
  • Travel plans that do not permit full participation especially during the first 8 study visits
  • Recent unexplained weight loss (10 pounds or more in past 3 months)
  • Any diagnosis that would interfere with or prevent a change in diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Mladen Golubic, MD, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 11, 2022

Record last verified: 2022-05