A dietary and behavioral intervention to improve health and sustainability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a comprehensive lifestyle intervention that includes dietary advice, behavioral support, and provision of key foods. It aims to improve nutritional status, metabolic risk factors, and promote planetary sustainability among participants. A total of 300 individuals will be recruited from diverse socioeconomic backgrounds in Gothenburg and will undergo a twelve-week randomized, controlled intervention. The study will compare the optimized intervention against standard dietary advice and behavioral support alone.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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.

Where it's running

• Center for Lifestyle Interventions, Sahlgrenska University Hospital, Östra
  Gothenburg, Sweden Recruiting

Study contacts

• Study coordinator: Rikard Landberg, Professor
• Email: rikard.landberg@chalmers.se
• Phone: +46723509386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.