Type 2 Diabetes MellitusSUKALMENANCT04449120
HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus
A study testing Mediterranean diet-based culinary intervention and Mediterranean diet-based nutritional education intervention in people with Type 2 Diabetes Mellitus, run by Basque Culinary Center Fundazioa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Mediterranean diet-based culinary intervention and Mediterranean diet-based nutritional education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus (SUKALMENA)
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.
Read more
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Mediterranean diet-based culinary intervention, Mediterranean diet-based nutritional education intervention
- Keywords
- Mediterranean diet, Culinary intervention, Cooking classes, Home cooking
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet-based culinary interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mediterranean diet-based culinary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; three months follow-up
Secondary outcomes (14)
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
Change in fat mass
At baseline and at 3 months of follow-up, fat mass will be analyzed by bioimpedance.
Measured: Baseline; three months follow-up
Change in fat free mass
At baseline and at 3 months of follow-up, fat free mass will be analyzed by bioimpedance.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; one month; three months follow-up
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.
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
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
Measured: Baseline; three months follow-up
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.
Measured: Baseline; three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jun 2020
- Primary completion15 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Culinary Center Fundazioa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Usune Etxeberria, PhD, Principal investigator, Basque Culinary Center Fundazioa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449120
- Sponsor's protocol ID
- 04.0006.19
- Acronym
- SUKALMENA
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29262811Reicks 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.
PubMed 28958671Byrne 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.
PubMed 29047323Irl 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.
PubMed 31543284Polak 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.
PubMed 30218282
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOME COOKING: Health Empowerment Strategy in People With Type II Diabetes Mellitus (SUKALMENA)
- ClinicalTrials.gov ID
- NCT04449120
- Acronym / sponsor ID
- SUKALMENA / 04.0006.19
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Mediterranean diet, Culinary intervention, Cooking classes, Home cooking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Basque Culinary Center FundazioaUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutritional education group (NEG) | Active comparator | Behavioral: Mediterranean diet-based nutritional education interventionParticipants 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. |
| Culinary intervention group (CIG) | Experimental | Behavioral: Mediterranean diet-based culinary interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet-based culinary interventionThe 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. | Behavioural | Culinary intervention group (CIG) |
| Mediterranean diet-based nutritional education interventionThe 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. | Behavioural | Nutritional education group (NEG) |
Primary outcome
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.
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.
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.
14 secondary outcomes
Change in advanced glycation end products (AGEs) level
Time frame: Baseline; three months follow-up
Changes in hip circumference
Time frame: Baseline; three months follow-up
Changes in waist circumference
Time frame: Baseline; three months follow-up
Changes in body mass index (BMI)
Time frame: Baseline; three months follow-up
Change in fat mass
Time frame: Baseline; three months follow-up
Change in fat free mass
Time frame: Baseline; three months follow-up
Changes in lipid metabolism parameters
Time frame: Baseline; three months follow-up
Change in blood pressure
Time frame: Baseline; three months follow-up
Change in plasma C-reactive protein
Time frame: Baseline; three months follow-up
Change in adherence to the Mediterranean Diet measured by Mediterranean Diet Adherence Screener
Time frame: Baseline; one month; three months follow-up
Change in dietary intake measured by validated Food Frequency Questionnaire (FFQ)
Time frame: Baseline; three months follow-up
Change in quality of life measured by Quality of Life Questionnaire
Time frame: Baseline; three months follow-up
Change in physical activity level measured by the Minnesota Leisure-Time Physical Activity Questionnaire
Time frame: Baseline; three months follow-up
Change in culinary habits measured by Culinary Habits Frequency Questionnaire (CHFC)
Time frame: Baseline; three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Background: PubMed 29262811Bernardo 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.
- Background: PubMed 28958671Reicks 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.
- Background: PubMed 29047323Byrne 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.
- Background: PubMed 31543284Irl 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.
- Background: PubMed 30218282Polak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usune Etxeberria, PhD principal investigator
Basque Culinary Center Fundazioa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet-based culinary intervention and Mediterranean diet-based nutritional education intervention in people with Type 2 Diabetes Mellitus, run by Basque Culinary Center Fundazioa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting glycosylated hemoglobin level (time frame: Baseline; three months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449120, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.