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

NCT04449120 | Completed

• 1 other identifier: 04.0006.19
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Mediterranean diet; Culinary intervention; Cooking classes; Home cooking

Outcome Measures

Primary Outcomes (3)

• Change in fasting glycosylated hemoglobin level

  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.

  Baseline; three months follow-up

• Change in fasting glucose level

  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.

  Baseline; three months follow-up

• Change in fasting insulin level

  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.

  Baseline; three months follow-up

Secondary Outcomes (14)

• Change in advanced glycation end products (AGEs) level

  Baseline; three months follow-up

• Changes in hip circumference

  Baseline; three months follow-up

• Changes in waist circumference

  Baseline; three months follow-up

• Changes in body mass index (BMI)

  Baseline; three months follow-up

• Change in fat mass

  Baseline; three months follow-up

Study Arms (2)

Nutritional education group (NEG)

ACTIVE COMPARATOR

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

Culinary intervention group (CIG)

EXPERIMENTAL

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

Interventions

Mediterranean diet-based culinary intervention BEHAVIORAL

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.

Culinary intervention group (CIG)

Mediterranean diet-based nutritional education intervention BEHAVIORAL

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.

Nutritional education group (NEG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Basque Culinary Center Fundazioa: lead
• University of Navarra: collaborator

Study Sites (1)

Basque Culinary Center

Donostia / San Sebastian, Guipuzcoa, 20009, Spain

Location

Related Publications (5)

• Bernardo GL, Jomori MM, Fernandes AC, Colussi CF, Condrasky MD, Proenca RPDC. Nutrition and Culinary in the Kitchen Program: a randomized controlled intervention to promote cooking skills and healthy eating in university students - study protocol. Nutr J. 2017 Dec 20;16(1):83. doi: 10.1186/s12937-017-0305-y.

  PMID: 29262811 BACKGROUND

• Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. 2018 Feb;50(2):148-172.e1. doi: 10.1016/j.jneb.2017.08.004. Epub 2017 Sep 25.

  PMID: 28958671 BACKGROUND

• Byrne C, Kurmas N, Burant CJ, Utech A, Steiber A, Julius M. Cooking Classes: A Diabetes Self-Management Support Intervention Enhancing Clinical Values. Diabetes Educ. 2017 Dec;43(6):600-607. doi: 10.1177/0145721717737741. Epub 2017 Oct 19.

  PMID: 29047323 BACKGROUND

• Irl B H, Evert A, Fleming A, Gaudiani LM, Guggenmos KJ, Kaufer DI, McGill JB, Verderese CA, Martinez J. Culinary Medicine: Advancing a Framework for Healthier Eating to Improve Chronic Disease Management and Prevention. Clin Ther. 2019 Oct;41(10):2184-2198. doi: 10.1016/j.clinthera.2019.08.009. Epub 2019 Sep 20.

  PMID: 31543284 BACKGROUND

• Polak R, Tirosh A, Livingston B, Pober D, Eubanks JE Jr, Silver JK, Minezaki K, Loten R, Phillips EM. Preventing Type 2 Diabetes with Home Cooking: Current Evidence and Future Potential. Curr Diab Rep. 2018 Sep 14;18(10):99. doi: 10.1007/s11892-018-1061-x.

  PMID: 30218282 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Usune Etxeberria, PhD

  Basque Culinary Center Fundazioa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 26, 2020
• Study Start: June 1, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 30, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)