Status:
RECRUITING
The SWITCH Dietary and Behavioural Intervention Study
Lead Sponsor:
Chalmers University of Technology
Collaborating Sponsors:
Göteborg University
Vastra Gotaland Region
Conditions:
Dietary Behaviour
Dietary Intakes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06973408
Start Date
March 3 2025
End Date
November 30 2026
Last Update
May 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Lifestyle Interventions, Sahlgrenska University Hospital, Östra
Gothenburg, Sweden