Dietary BehaviourSWITCHNCT06973408
The SWITCH Dietary and Behavioural Intervention Study
A study testing Behavioral Treatment, Food support and Dietary Advice in people with Dietary Behaviour and Dietary Intakes, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behaviour, Dietary Intakes, Dietary Intervention
- What is being tested?
- Behavioral Treatment, Food support and Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Body mass index 25-35 kg/m2
- Stable dietary patterns at the entry to the study (no specific dieting the last 4 weeks).
- Willingness to adhere to advised diet pattern and to consume provided key foods.
- Medications stable for the previous 14 days of relevant medicines
- Access to a -18⁰ C freezer to store key foods at home.
- Signed informed consent
Who cannot join
- Currently having an infection or other relevant illness.
- Cardiovascular events (myocardial infarction or stroke) during the previous 6 months. To be included, the disease needs to be stable.
- Diagnosis of diabetes (any type).
- Blood Pressure (BP): ≥185/105 mmHg.
- Serum Cholesterol (S-Chol): ≥8 mmol/L.
- Blood Glucose (B-Glucose): fasting value >7 mmol/L.
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- Currently on GLP-1 receptor agonists.
- History of stomach or gastrointestinal diagnoses (inflammatory bowel disease, Crohn's disease, hepatitis, malabsorption, celiac disease etc.).
- IBS- if severe and recent (<0.5year)?
- Previous colostomy, bowel resection, bariatric surgery or other major gastrointestinal surgery.
- Renal or liver failure (creatinine <1.7 mg/dl and alanine aminotransferase/ aspartate aminotransferase > 2 times than normal values (ASAT, ALAT), respectively).
- Anemia or Hemoglobin (Hb): <100 g/L
- Blood donation (or participation in a clinical study with blood sampling) within 30 days prior to inclusion
- Currently on a specific diet.
- A diet incompatible with protocol diets such as strict vegan/vegetarian.
- Food allergies or intolerances to food items included in the intervention.
- High level of regular physical activity at baseline - scale 4 on SG-PALS.
- History of drug or alcohol abuse.
- Not able to understand written or spoken Swedish.
- Any other reason for lack of suitability for participation in the trial, as judged by the principal investor and/ or the clinical investigator.
- Pregnant or lactating or planning to become pregnant during the study period.
- Involved in another potentially interfering research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Center for Lifestyle Interventions, Sahlgrenska University Hospital, Östra
Gothenburg
Mats Börjesson, Professor, +4631-3435398, mats.borjesson@gu.se
About this study
Official title: Switching to a Healthy and Sustainable Diet for Planetary and Human Health
The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. The intervention aims to improve nutritional status, metabolic risk factors, and planetary sustainability.
A total of 300 participants (150 men and 150 women) who meet all inclusion criteria and none of the exclusion criteria will be recruited. The study will be conducted at the Centre for Lifestyle Intervention at Östra Hospital in Gothenburg, led by researchers from Chalmers University of Technology, University of Gothenburg, and Sahlgrenska University Hospital. Participants will be recruited from two different socioeconomic areas in Gothenburg to examine how dietary interventions function in diverse population groups.
Read more
The study follows a twelve-week randomized, controlled, parallel intervention design. Participants will be randomized into three groups, each with 100 individuals:
Optimized lifestyle intervention group - receiving dietary advice, behavioral support, and provision of key foods.
Behavioral support intervention group - receiving dietary advice and behavioral support.
Control group - receiving dietary advice according to the SWITCH diet. The SWITCH diet, developed within the EU project SWITCH, is designed to align with European dietary guidelines and promote sustainable and healthy eating habits. It emphasizes whole grains, vegetables, fruits, legumes, and sustainable seafood while limiting processed foods, added sugars, and salt.
Throughout the study, participants will undergo clinical assessments at baseline, midpoint (week 7), and endpoint (week 13). Key measurements include anthropometric data, blood pressure, blood glucose, blood lipids, and inflammatory markers. Dietary intake and sustainability aspects of food consumption will also be evaluated. Participants in the intervention groups will receive personalized coaching and access to practical resources, such as meal plans, recipes, and visual educational materials.
The primary outcome of the study is the difference in cardiometabolic risk factors (e.g., blood lipids, blood pressure, glucose, insulin resistance markers) between the intervention groups. Secondary outcomes include changes in dietary intake, nutritional status markers, inflammatory markers, and sustainability measures (e.g., CO₂ emissions, land use, biodiversity impact). Additionally, exploratory analyses will investigate associations between diet, lifestyle changes, gut microbiota, and metabolic responses.
This study aims to generate valuable insights into the effectiveness of different dietary intervention strategies in real-life Nordic conditions. The results will contribute to the development of evidence-based recommendations for sustainable and health-promoting dietary patterns.
- Conditions
- Dietary Behaviour, Dietary Intakes, Dietary Intervention, Metabolic Diseases, Blood Lipid Profiles, Blood Glucose Metabolism
- Being tested
- Behavioral Treatment, Food support, Dietary Advice
- Keywords
- Cardiometabolic health, Lifestyle intervention, Dietary adherence, Sustainable diet, Nordic diet, Metabolic risk factors, Randomized controlled trial, nevironmental impact of diet
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
Also called Behavioural support
Behavioral support is designed to help participants adhere to the dietary recommendations through personalized coaching and motivational strategies. Participants engage in weekly or bi-weekly coaching sessions, either online or in person, where they receive guidance on overcoming challenges and maintaining dietary changes. The coaching incorporates evidence-based behavior change techniques, such as goal setting, self-monitoring, feedback on performance, problem-solving, and stimulus control. To further support behavior change, participants receive practical tools, including visual aids, educational videos, and structured meal planning resources. The overall goal of behavioral support is to encourage sustainable dietary habits by providing continuous encouragement and individualized strategies.
Food supportBehavioural
Food support, which is provided exclusively to participants in the Optimized Lifestyle Intervention Group, ensures that they have access to key foods required to meet dietary targets. These foods include whole grains such as whole grain bread, oats, and pasta; vegetables in both fresh and frozen forms; fruits and berries, including apples, pears, and frozen berries; legumes such as lentils, beans, and chickpeas; and seafood, including fatty fish, lean fish, and mussels. To facilitate adherence, participants also receive recipes and meal plans that incorporate these foods. Some fresh food items are made available at supermarkets near participants' residences to improve accessibility and convenience. Food support aims to reduce barriers to dietary change by ensuring that participants have the necessary ingredients to follow the SWITCH diet effectively.
Dietary AdviceBehavioural
Dietary advice consists of a simple document outlining the SWITCH diet, which is based on European and Nordic dietary guidelines. Participants receive this information in written form without any additional guidance, counseling, or support. The SWITCH diet emphasizes increased consumption of whole grains, vegetables, fruits, legumes, and seafood while limiting processed foods, added sugars, and excessive salt.
| Study group | Role | What they receive |
|---|---|---|
| Optimized lifestyle intervention group | Experimental | Receiving dietary advice, behavioral support, and provision of key foods. Receives: Behavioral: Behavioral Treatment; Behavioral: Food support; Behavioral: Dietary Advice |
| Behavioral support intervention group | Active comparator | Receiving dietary advice and behavioral support Receives: Behavioral: Behavioral Treatment; Behavioral: Dietary Advice |
| Control group | Other | Receiving dietary advice according to the SWITCH diet. Receives: Behavioral: Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Changes in fasting LDL cholesterol
Measured: After 6 and 12 weeks of intervention
HDL cholesterol
Changes in fasting HDL cholesterol
Measured: After 6 and 12 weeks of intervention
non-HDL cholesterol
Changes in fasting nonHDL cholesterol
Measured: After 6 and 12 weeks of intervention
Total cholesterol
Changes in fasting total cholesterol
Measured: After 6 and 12 weeks of intervention
Triglyceride
Changes in fasting triglycerides
Measured: After 6 and 12 weeks of intervention
Blood pressure
Change in systolic and/or diastolic blood pressure
Measured: After 6 and 12 weeks of intervention
Blood glucose
Changes in fasting blood glucose levels
Measured: After 6 and 12 weeks of intervention
Insulin
Changes in c-peptid in fasting samples
Measured: After 6 and 12 weeks of intervention
Secondary outcomes (4)
Intake of key food groups and key nutrients
Intake of eg. whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids.
Measured: After 6 and 12 weeks of intervention
Nutritional status markers
Eg. fatty acids, vitamin D, iron, selenium, iodine, zink, folate and B12
Measured: After 6 and 12 weeks of intervention
Planetary sustainability measurements
Carbon footprint, cropland use, new input of N and phosphorus (P), blue water use, pesticide use, biodiversity impact, land use and ammonia emissions
Measured: After 6 and 12 weeks of intervention
Inflammatory markers
IL-6 and CRP
Measured: After 6 and 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start3 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary BehaviourStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Vastra Gotaland Region
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973408
- Sponsor's protocol ID
- SWITCH
- Acronym
- SWITCH
- Status last verified
- May 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching to a Healthy and Sustainable Diet for Planetary and Human Health
- ClinicalTrials.gov ID
- NCT06973408
- Acronym / sponsor ID
- SWITCH / SWITCH
- Conditions
- Dietary Behaviour, Dietary Intakes, Dietary Intervention, Metabolic Diseases, Blood Lipid Profiles, Blood Glucose Metabolism
- Keywords
- Cardiometabolic health, Lifestyle intervention, Dietary adherence, Sustainable diet, Nordic diet, Metabolic risk factors, Randomized controlled trial, nevironmental impact of diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Göteborg University, Vastra Gotaland Region
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 May 2025 (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.
The overall objective of this study is to evaluate the effectiveness of an optimized lifestyle intervention based on dietary advice, behavioral support, and provision of key foods compared to dietary advice with behavioral support or dietary advice alone. The intervention aims to improve nutritional status, metabolic risk factors, and planetary sustainability.
A total of 300 participants (150 men and 150 women) who meet all inclusion criteria and none of the exclusion criteria will be recruited. The study will be conducted at the Centre for Lifestyle Intervention at Östra Hospital in Gothenburg, led by researchers from Chalmers University of Technology, University of Gothenburg, and Sahlgrenska University Hospital. Participants will be recruited from two different socioeconomic areas in Gothenburg to examine how dietary interventions function in diverse population groups.
The study follows a twelve-week randomized, controlled, parallel intervention design. Participants will be randomized into three groups, each with 100 individuals:
Optimized lifestyle intervention group - receiving dietary advice, behavioral support, and provision of key foods.
Behavioral support intervention group - receiving dietary advice and behavioral support.
Control group - receiving dietary advice according to the SWITCH diet. The SWITCH diet, developed within the EU project SWITCH, is designed to align with European dietary guidelines and promote sustainable and healthy eating habits. It emphasizes whole grains, vegetables, fruits, legumes, and sustainable seafood while limiting processed foods, added sugars, and salt.
Throughout the study, participants will undergo clinical assessments at baseline, midpoint (week 7), and endpoint (week 13). Key measurements include anthropometric data, blood pressure, blood glucose, blood lipids, and inflammatory markers. Dietary intake and sustainability aspects of food consumption will also be evaluated. Participants in the intervention groups will receive personalized coaching and access to practical resources, such as meal plans, recipes, and visual educational materials.
The primary outcome of the study is the difference in cardiometabolic risk factors (e.g., blood lipids, blood pressure, glucose, insulin resistance markers) between the intervention groups. Secondary outcomes include changes in dietary intake, nutritional status markers, inflammatory markers, and sustainability measures (e.g., CO₂ emissions, land use, biodiversity impact). Additionally, exploratory analyses will investigate associations between diet, lifestyle changes, gut microbiota, and metabolic responses.
This study aims to generate valuable insights into the effectiveness of different dietary intervention strategies in real-life Nordic conditions. The results will contribute to the development of evidence-based recommendations for sustainable and health-promoting dietary patterns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimized lifestyle intervention group | Experimental | Behavioral: Behavioral Treatment, Behavioral: Food support, Behavioral: Dietary AdviceReceiving dietary advice, behavioral support, and provision of key foods. |
| Behavioral support intervention group | Active comparator | Behavioral: Behavioral Treatment, Behavioral: Dietary AdviceReceiving dietary advice and behavioral support |
| Control group | Other | Behavioral: Dietary AdviceReceiving dietary advice according to the SWITCH diet. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years
- Body mass index 25-35 kg/m2
- Stable dietary patterns at the entry to the study (no specific dieting the last 4 weeks).
- Willingness to adhere to advised diet pattern and to consume provided key foods.
- Medications stable for the previous 14 days of relevant medicines
Key exclusion criteria (22 listed)
- Currently having an infection or other relevant illness.
- Cardiovascular events (myocardial infarction or stroke) during the previous 6 months. To be included, the disease needs to be stable.
- Diagnosis of diabetes (any type).
- Blood Pressure (BP): ≥185/105 mmHg.
- Serum Cholesterol (S-Chol): ≥8 mmol/L.
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 |
|---|---|---|
| Behavioral TreatmentAlso: Behavioural supportBehavioral support is designed to help participants adhere to the dietary recommendations through personalized coaching and motivational strategies. Participants engage in weekly or bi-weekly coaching sessions, either online or in person, where they receive guidance on overcoming challenges and maintaining dietary changes. The coaching incorporates evidence-based behavior change techniques, such as goal setting, self-monitoring, feedback on performance, problem-solving, and stimulus control. To further support behavior change, participants receive practical tools, including visual aids, educational videos, and structured meal planning resources. The overall goal of behavioral support is to encourage sustainable dietary habits by providing continuous encouragement and individualized strategies. | Behavioural | Behavioral support intervention group, Optimized lifestyle intervention group |
| Food supportFood support, which is provided exclusively to participants in the Optimized Lifestyle Intervention Group, ensures that they have access to key foods required to meet dietary targets. These foods include whole grains such as whole grain bread, oats, and pasta; vegetables in both fresh and frozen forms; fruits and berries, including apples, pears, and frozen berries; legumes such as lentils, beans, and chickpeas; and seafood, including fatty fish, lean fish, and mussels. To facilitate adherence, participants also receive recipes and meal plans that incorporate these foods. Some fresh food items are made available at supermarkets near participants' residences to improve accessibility and convenience. Food support aims to reduce barriers to dietary change by ensuring that participants have the necessary ingredients to follow the SWITCH diet effectively. | Behavioural | Optimized lifestyle intervention group |
| Dietary AdviceDietary advice consists of a simple document outlining the SWITCH diet, which is based on European and Nordic dietary guidelines. Participants receive this information in written form without any additional guidance, counseling, or support. The SWITCH diet emphasizes increased consumption of whole grains, vegetables, fruits, legumes, and seafood while limiting processed foods, added sugars, and excessive salt. | Behavioural | Behavioral support intervention group, Control group, Optimized lifestyle intervention group |
Primary outcome
LDL cholesterol
Time frame: After 6 and 12 weeks of intervention
Changes in fasting LDL cholesterol
HDL cholesterol
Time frame: After 6 and 12 weeks of intervention
Changes in fasting HDL cholesterol
non-HDL cholesterol
Time frame: After 6 and 12 weeks of intervention
Changes in fasting nonHDL cholesterol
Total cholesterol
Time frame: After 6 and 12 weeks of intervention
Changes in fasting total cholesterol
Triglyceride
Time frame: After 6 and 12 weeks of intervention
Changes in fasting triglycerides
Blood pressure
Time frame: After 6 and 12 weeks of intervention
Change in systolic and/or diastolic blood pressure
Blood glucose
Time frame: After 6 and 12 weeks of intervention
Changes in fasting blood glucose levels
Insulin
Time frame: After 6 and 12 weeks of intervention
Changes in c-peptid in fasting samples
4 secondary outcomes
Intake of key food groups and key nutrients
Time frame: After 6 and 12 weeks of intervention
Nutritional status markers
Time frame: After 6 and 12 weeks of intervention
Planetary sustainability measurements
Time frame: After 6 and 12 weeks of intervention
Inflammatory markers
Time frame: After 6 and 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment, Food support and Dietary Advice in people with Dietary Behaviour and Dietary Intakes, run by Chalmers University of Technology at 1 site in Sweden.
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 7 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikard Landberg, Professor (+46723509386, rikard.landberg@chalmers.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol (time frame: After 6 and 12 weeks of intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.