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HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus (SUKALMENA)

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ClinicalTrials.gov Identifier: NCT04449120
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
University of Navarra
Information provided by (Responsible Party):
Basque Culinary Center Fundazioa

Brief Summary:

Currently, one of the health challenges in the field of public health is to improve the quality of life of people with metabolic diseases, using new strategies that allow to promote healthy eating habits.

Within the new strategies that may encourage population improving eating habits, "HOMECOOKING" is proposed as a transforming tool for health, involving culinary skills and knowledge in nutrition. It is suggested as a new paradigm in nutritional education.

This project will cover the "HOMECOOKING: cooking and eating at home", as an innovative strategy, aiming to improve the quality of the diet of people with type II diabetes mellitus through an intervention based on cooking workshops. At these sessions, participants will learn easy cooking techniques and tools, in order to acquire culinary competences and to be empowered to prepare healthy dishes.

The effect of this intervention programme on the health of the participants will be evaluated through the measurement of biochemical parameters related to the disease (glycosylated haemoglobin, insulin, glucose, among others). In addition, specific compounds known as advanced glycation end products (AGEs) will be measured. The formation of these compounds is associated with the type of food consumed and the culinary techniques that are applied.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Mediterranean diet-based culinary intervention Behavioral: Mediterranean diet-based nutritional education intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This study uses a randomized controlled trial design with one-month intervention program and three months of follow-up in order to test the effects of a culinary intervention program to improve cooking and healthy eating behaviour in type 2 diabetic patients.

The culinary intervention program will be given over a one-month period, one day a week for four weeks. Participants in the control group (CG) will receive dietary training based on Mediterranean diet at the baseline visit and a leaflet explaining this dietary pattern. The participants assigned to the culinary intervention program will receive the same nutritional recommendations and four online cooking classes.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus (SUKALMENA)
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nutritional education group (NEG)

Participants in the nutritional education group will be given a leaflet with written nutrition educational information to follow a Mediterranean diet. Participants will be encouraged to adhere to this diet for one-month. Three visits will be scheduled for participants assigned to this group:

(1) before randomization (T1); (2) after randomization and before the program´s beginning (T2); and (3) after three months of follow-up period. In all time-points, questionnaires will be registered and at T2 and T3 blood samples will be collected. Volunteers will be contacted by phone after 1 month and 6 months of the end of the intervention to collect information about food and culinary habits.

Behavioral: Mediterranean diet-based nutritional education intervention
The patients in the nutritional intervention group will receive dietary advice on how to follow a Mediterranean diet. The dietary recommendations will be given at the beginning of the study by nutritionists using comprehensive written material.

Experimental: Culinary intervention group (CIG)

Participants assigned to the culinary intervention group received the written nutrition educational information as well as four online cooking classes (one cooking class per week) during the one-month intervention period. Three visits will be scheduled for participants assigned to this group:

(1) before randomization (T1); (2) after randomization and before the program´s beginning (T2); and (3) after three months of follow-up period. In all time-points, questionnaires will be registered and at T2 and T3 blood samples will be collected.

Participants will attend 4 culinary workshops between visit 2 and 3. Volunteers will be contacted by phone after 1 month and 6 months of the end of the intervention to collect information about food and culinary habits.

Behavioral: Mediterranean diet-based culinary intervention
The culinary intervention was developed integrating four culinary workshops that were given every week, once per week, during one-month intervention. The duration of each culinary workshop was 3,5 h, thus, the program provided a total of 14h of practice in cooking activities. The courses took place in a well-equipped kitchen from the Basque Culinary Center. Each culinary workshop was divided in two differentiated parts in order to work on the specific objectives established for each day. All cooking classes began with a theoretical introductory part that aimed to explain the main take-home messages from the workshop. Subsequently, every class was characterized by a hands-on part that included the demonstration and practical preparation of different elaborations based on the use specific cooking techniques and healthy ingredients. At the end of the session, participants were encouraged to taste the prepared meals, to share their preferences and their view about the cooking experience.




Primary Outcome Measures :
  1. Change in fasting glycosylated hemoglobin level [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of hemoglobin A1c. At 3 months of follow-up, the determination of this parameter will be repeated.

  2. Change in fasting glucose level [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of fasting glucose levels. At 3 months of follow-up, the determination of this parameter will be repeated.

  3. Change in fasting insulin level [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of fasting insulin levels. At 3 months of follow-up, the determination of this parameter will be repeated.


Secondary Outcome Measures :
  1. Change in advanced glycation end products (AGEs) level [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of advanced glycation end products levels. At 3 months of follow-up, this determination will be repeated.

  2. Changes in hip circumference [ Time Frame: Baseline; three months follow-up ]
    At baseline, hip circumference will be measured with a measuring. At 3 months of follow-up , the determination of this measurement will be repeated.

  3. Changes in waist circumference [ Time Frame: Baseline; three months follow-up ]
    At baseline, waist circumference will be measured with a measuring. At 3 months of follow-up , the determination of this measurement will be repeated.

  4. Changes in body mass index (BMI) [ Time Frame: Baseline; three months follow-up ]
    BMI will be calculated as body weight (kg) divided by height (m) squared at baseline and at 3 months of follow up.

  5. Change in fat mass [ Time Frame: Baseline; three months follow-up ]
    At baseline and at 3 months of follow-up, fat mass will be analyzed by bioimpedance.

  6. Change in fat free mass [ Time Frame: Baseline; three months follow-up ]
    At baseline and at 3 months of follow-up, fat free mass will be analyzed by bioimpedance.

  7. Changes in lipid metabolism parameters [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of in fasting total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides levels. At 3 months of follow-up, the determination of these parameters will be repeated.

  8. Change in blood pressure [ Time Frame: Baseline; three months follow-up ]

    At baseline systolic blood pressure and diastolic blood pressure will be reported in mmHg.

    At 3 months of follow-up, the determination of systolic and diastolic blood pressure will be repeated.


  9. Change in plasma C-reactive protein [ Time Frame: Baseline; three months follow-up ]
    At baseline blood samples will be collected for determination of C-reactive protein. At 3 months of follow-up, the determination of this parameter will be repeated.

  10. Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener [ Time Frame: Baseline; one month; three months follow-up ]
    At baseline data about adherence to the Mediterranean Diet will be collected by a 14-point Mediterranean Diet Adherence Screener (MEDAS). At 1 and 3 months of follow-up these data will be also collected.

  11. Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ) [ Time Frame: Baseline; three months follow-up ]
    At baseline data about dietary intake will be collected by using a Food Frequency Questionnaire (FFQ). At 3 months of follow-up, these data will be also collected.

  12. Change in quality of life measured by Quality of Life Questionnaire [ Time Frame: Baseline; three months follow-up ]
    At baseline and at 3 months of follow-up, data about quality of life will be measured by Quality of Life Questionnaire.

  13. Change in physical activity level measured by the Minnesota Leisure-Time Physical Activity Questionnaire [ Time Frame: Baseline; three months follow-up ]
    At baseline and at 3 months of follow-up, data about physical activity level will be collected by the Minnesota Leisure-Time Physical Activity Questionnaire

  14. Change in culinary habits measured by Culinary Habits Frequency Questionnaire (CHFC) [ Time Frame: Baseline; three months follow-up ]
    At baseline and at 3 months of follow-up, data about culinary habits will be collected by culinary habits frequency questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 Diabetes Mellitus without treatment with insulin, sulfonylureas and glinides.
  • Overweight or obesity (BMI between 25 and 40 kg/m2).
  • Stable treatment with oral antidiabetics, other than sulfonylureas or glinides, at least for 3 months.

Exclusion Criteria:

  • Treatment with insulin, sulfonylureas or glinides
  • Glycosylated hemoglobin (HbA1c) concentration greater than 10%
  • Weight loss exceeding 5 kg in the past three months
  • Pregnant or breastfeeding women
  • Serious medical condition that impedes from conducting the dietary intervention or that limits the survival to less than one year
  • Consumption of illegal drugs, chronic alcoholism or alcohol total consumption above 80 g/day
  • Participation in other clinical trial with drugs or nutritional intervention during the previous year to inclusion
  • Major difficulties or inconveniences in changing dietary habits and following the Mediterranean Diet (allergies, intolerances)
  • Difficulties for regular home cooking and/or eating out more than 2 days per week
  • Current diagnosis of an eating disorder, schizophrenia, other psychotic disorder or bipolar disorder
  • Hospitalization for any mental illness in the previous year
  • History of bariatric surgery or extensive bowel resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04449120


Contacts
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Contact: Lucía Gayoso, PhD 683512569 lgayoso@bculinary.com
Contact: Usune Etxeberria, PhD 682395326 uetxeberria@bculinary.com

Locations
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Spain
Basque Culinary Center Recruiting
Donostia-San Sebastian, Guipuzcoa, Spain, 20009
Contact: Lucia Gayoso       lgayoso@bculinary.com   
Sponsors and Collaborators
Basque Culinary Center Fundazioa
University of Navarra
Investigators
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Principal Investigator: Usune Etxeberria, PhD Basque Culinary Center Fundazioa
Publications:
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Responsible Party: Basque Culinary Center Fundazioa
ClinicalTrials.gov Identifier: NCT04449120    
Other Study ID Numbers: 04.0006.19
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Basque Culinary Center Fundazioa:
Mediterranean diet
Culinary intervention
Cooking classes
Home cooking
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases