New treatment option for Dietary Behaviour
Official title The SWITCH Dietary and Behavioural Intervention Study
ClinicalTrials.gov ID: NCT06973408
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.