A dietary and behavioral intervention to improve health and sustainability
Switching to a Healthy and Sustainable Diet for Planetary and Human Health
NA · Chalmers University of Technology · NCT06973408
This study is testing a new lifestyle program that combines diet tips and support to see if it can help people improve their health and the environment better than regular diet advice alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chalmers University of Technology (other) |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06973408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI between 25-35 who are willing to adhere to dietary changes.
Not a fit: Patients with recent cardiovascular events, diabetes, or severe gastrointestinal issues may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance dietary habits and metabolic health for participants, leading to improved overall health outcomes.
How similar studies have performed: Previous studies have shown that lifestyle interventions can effectively improve dietary behaviors and metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gothenburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dietary Behaviour, Dietary Intakes, Dietary Intervention, Metabolic Diseases, Blood Lipid Profiles, Blood Glucose Metabolism, Diet, Healthy, Cardiometabolic health