Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Göteborg University | OTHER |
| Vastra Gotaland Region | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized lifestyle intervention group | Experimental | Receiving dietary advice, behavioral support, and provision of key foods. |
|
| Behavioral support intervention group | Active Comparator | Receiving dietary advice and behavioral support |
|
| Control group | Other | Receiving dietary advice according to the SWITCH diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | Changes in fasting LDL cholesterol | After 6 and 12 weeks of intervention |
| HDL cholesterol | Changes in fasting HDL cholesterol | After 6 and 12 weeks of intervention |
| non-HDL cholesterol | Changes in fasting nonHDL cholesterol | After 6 and 12 weeks of intervention |
| Total cholesterol | Changes in fasting total cholesterol | After 6 and 12 weeks of intervention |
| Triglyceride | Changes in fasting triglycerides | After 6 and 12 weeks of intervention |
| Blood pressure | Change in systolic and/or diastolic blood pressure | After 6 and 12 weeks of intervention |
| Blood glucose | Changes in fasting blood glucose levels | After 6 and 12 weeks of intervention |
| Insulin | Changes in c-peptid in fasting samples | After 6 and 12 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 and 12 weeks of intervention |
| Nutritional status markers |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between dietary changes and gut microbiota | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and gut microbiota | After 6 and 12 weeks of intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rikard Landberg, Professor | Contact | +46723509386 | rikard.landberg@chalmers.se | |
| Malin Barman, Docent | Contact | +46317722393 | malin.barman@chalmers.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Lifestyle Interventions, Sahlgrenska University Hospital, Östra | Recruiting | Gothenburg | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Food support | Behavioral | 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 Advice | Behavioral | 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. |
|
Eg. fatty acids, vitamin D, iron, selenium, iodine, zink, folate and B12 |
| 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 | After 6 and 12 weeks of intervention |
| Inflammatory markers | IL-6 and CRP | After 6 and 12 weeks of intervention |
| Correlation between dietary changes and plasma- and urinary metabolomes |
Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and plasma and urinary metabolomes |
| After 6 and 12 weeks of intervention |
| Correlation between lifestyle changes and plasma- and urinary metabolomes | Exploratory associations between lifestyle changes and plasma- and urinary metabolomes | After 6 and 12 weeks of intervention |
| Correlation between lifestyle changes and gut microbiota | Exploratory associations between lifestyle changes and gut microbiota | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and HDL | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and HDL | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and non-HDL | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and non-HDL | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and total cholesterol | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and total cholesterol | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and triglycerides | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and triglycerides | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and blood pressure | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and systolic and diastolic blood pressure | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and blood glucose | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and and blood glucose | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and blood glucose | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and blood glucose | After 6 and 12 weeks of intervention |
| Correlation between changes in dietary intakes and insulin | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and insulin | After 6 and 12 weeks of intervention |
| Correlations between changes in dietary intakes and behavioral outcomes | Correlation between changes in dietary intakes (whole grains, marine foods, legumes, fruits and vegetables, red and processed meats, dairy foods, sugar, starch, protein, dietary fibre, micronutrients and minerals, fatty acids) and behavioral outcomes | After 6 and 12 weeks of intervention |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |