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

Type 2 Diabetes Mellitus Clinical Trial

— SUKALMENA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449120
• Other study ID #: 04.0006.19
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2021
• Source: Basque Culinary Center Fundazioa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

One of the main factors influencing health is nutrition. Therefore, lifestyle and more specifically healthy eating habits, are key elements for the promotion of healthy lifestyle in society. Eating habits are defined as the more or less conscious, collective and repetitive behaviour that leads people to select, consume and use a certain foods or diet, in response to social and/or cultural influences. The acquisition of eating habits occurs since childhood. For this reason, an education in food and gastronomy is necessary to promote healthy eating habits in society. Education programmes so far have focused on nutrition education, i.e. on transferring theoretical knowledge about nutrition. However, currently, it is known that traditional knowledge about nutrition is not sufficient and it is necessary to go deeper into the factors that determine what people eat, and how people eat.

The studies related to the sensory perception of food and the relationship that this perception has with the choice of food, seek to decipher the keys that make different individuals to have certain eating habits based on: personal tastes, the influence of culture, the emotions that make them feel, learning, and so on. Nutritional recommendations will always be simpler to follow when, implicit in them, the tastes and food choices of each individual are found.

From a holistic perspective, individuals should be considered as a human being within a social, cultural and technological environment. In this sense, gastronomy is defined as "the reasoned knowledge of what people eat and how people eat. It is an interdisciplinary area of knowledge that studies and generates physical-chemical, cultural and socioeconomic processes where human beings cultivate, process, distribute and consume good foods and beverages that affect their physical, mental and social well-being". Gastronomy is a vehicle capable of creating social trends and the convergence of this discipline together with nutritional education can be a more effective tool to disseminate messages about what is considered a healthy diet, how to eat a healthy diet, as well as to transfer cooking skills that allow the population to acquire and sustain these eating habits at home.

Briefly, gastronomy plays a fundamental role in covering the nutritional needs of the general population, and at the same time, it satisfies their expectations of flavour. Therefore, gastronomy is considered a decisive channel to favour education of taste, a better nutrition and, in general, for health promotion.

The effect of nutrition on health is not homogeneous in the population. On the one hand, factors such as the type of food and the culinary techniques used have an influence. On the other hand, individual characteristics such as lifestyle, genetic background and wellbeing must be taken into account. In this context, Personalized and Precision Gastronomy based on individuals' eating habits, genetic profile, intestinal microbiota profile, metabolome, epigenome, tastes and preferences, and so on, in order to develop strategies that favour a healthy and tailor-made diets for each individual.

Type 2 diabetes mellitus (T2DM) is one of the most prevalent metabolic diseases worldwide. In the Basque Country, it is estimated that the disease affects 10% of the population. People with diabetes have a high risk of suffering complications related to this illness. In addition, people with T2DM are more prone to develop other diseases such as cardiovascular diseases as well as premature mortality. For this reason, it is necessary to prevent the disease and to try to reduce the risk of developing complications in people who have already been diagnosed with T2DM.

The current increase in DMT2 is associated with an increase in obesity. This multifactorial disease, in turn, has been related to unhealthy lifestyles. Moreover, apart from physical activity, following a healthy diet is a determining factor. Although there is increasing information on nutrition, the desired effect on the prevention of this disease is not being achieved. This may in part be due to a lack of skills to continue a healthy diet.

Attention should also being paid to individual factors that may influence in specific nutritional needs of T2DM. In this sense, personalised gastronomy can facilitate the empowerment of people with diabetes providing them with culinary techniques and skills that allow patients to follow a healthy diet adapted to the conditions of this disease and to personal needs and preferences.

In this context, the HOME COOKING project seeks to carry out a one-month culinary intervention programme with people diagnosed with T2DM, in order to analyse the health effects that the programme can produce, comparing it with the results obtained with a traditional intervention solely based on the training of theoretical recommendations about nutrition.

In conclusion, the main hypothesis of this project lies in the fact that one of the barriers for the population to acquire and maintain healthy eating habits is related, in part, to the fact that they do not have enough culinary skills (food preparation) and do not have sufficient knowledge about nutrition (knowledge about the product). Thus, bearing in mind that several studies have demonstrated the relationship between the trust (empowerment) that provides to have food preparation skills (culinary skills), and knowledge about the quality of the diet in terms of health, the present project suggests that beneficial effects on health can be obtained when nutritionists and public health professionals promote culinary intervention programmes aimed at providing theoretical and practical knowledge.

Therefore, this project is novel since it proposes a paradigm shift promoting the incorporation of culinary training as a complement to nutritional education. Likewise, the project is based on the Mediterranean diet, a diet pattern whose health benefits have been scientifically endorsed. The study is a reference project in this field and its results will be of great relevance to public health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Basque Culinary Center	Donostia-San Sebastian	Guipuzcoa

Sponsors (2)

Lead Sponsor	Collaborator
Basque Culinary Center Fundazioa	University of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Bernardo GL, Jomori MM, Fernandes AC, Colussi CF, Condrasky MD, Proença 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in advanced glycation end products (AGEs) level	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.	Baseline; three months follow-up
Secondary	Changes in hip circumference	At baseline, hip circumference will be measured with a measuring. At 3 months of follow-up , the determination of this measurement will be repeated.	Baseline; three months follow-up
Secondary	Changes in waist circumference	At baseline, waist circumference will be measured with a measuring. At 3 months of follow-up , the determination of this measurement will be repeated.	Baseline; three months follow-up
Secondary	Changes in body mass index (BMI)	BMI will be calculated as body weight (kg) divided by height (m) squared at baseline and at 3 months of follow up.	Baseline; three months follow-up
Secondary	Change in fat mass	At baseline and at 3 months of follow-up, fat mass will be analyzed by bioimpedance.	Baseline; three months follow-up
Secondary	Change in fat free mass	At baseline and at 3 months of follow-up, fat free mass will be analyzed by bioimpedance.	Baseline; three months follow-up
Secondary	Changes in lipid metabolism parameters	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.	Baseline; three months follow-up
Secondary	Change in blood pressure	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.	Baseline; three months follow-up
Secondary	Change in plasma C-reactive protein	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.	Baseline; three months follow-up
Secondary	Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener	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.	Baseline; one month; three months follow-up
Secondary	Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)	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.	Baseline; three months follow-up
Secondary	Change in quality of life measured by Quality of Life Questionnaire	At baseline and at 3 months of follow-up, data about quality of life will be measured by Quality of Life Questionnaire.	Baseline; three months follow-up
Secondary	Change in physical activity level measured by the Minnesota Leisure-Time Physical Activity Questionnaire	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	Baseline; three months follow-up
Secondary	Change in culinary habits measured by Culinary Habits Frequency Questionnaire (CHFC)	At baseline and at 3 months of follow-up, data about culinary habits will be collected by culinary habits frequency questionnaire.	Baseline; three months follow-up