Healthy LifestyleSOFIANCT06698094
Sustainable Office Intervention, Impact of a Sustainable Lifestyle on Diet, Physical Activity and Carbon Footprint
A study testing Sustainable lifestyle and Healthy lifestyle in people with Healthy Lifestyle and Healthy Diet, run by Mälardalen University at 1 site in Sweden.
Trial summary
The main goal of the study, Sustainable Office Intervention (SOFIA), is to promote and ease the adoption of a sustainable lifestyle within an office environment, with the dual goals of enhancing public health and mitigating the adverse effects of climate change. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Healthy Diet
- What is being tested?
- Sustainable lifestyle and Healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2022to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preform office work ≤20 hours/week
Who cannot join
- Allergies excluding large food groups
- Visual or speech disability
- Not owning a smartphone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Sustainable Lifestyle on Dietary Quality, CO2e Emissions and Physical Activity in Office Workers: a Study Protocol for a Cluster Randomized Controlled Trial (SOFIA Project)
The main goal of the study, Sustainable Office Intervention (SOFIA), is to promote and ease the adoption of a sustainable lifestyle within an office environment, with the dual goals of enhancing public health and mitigating the adverse effects of climate change. Specifically, the study aims to assess the effectiveness of promoting sustainable lifestyle choices in the office workplace compared to promoting a conventional healthy lifestyle in regards to diet and physical activity.
Read the detailed description
The participants will be recruited at companies in the Swedish office sector, and after recruitment and baseline assessment, the participants will be randomly assigned to one of two groups Healthy Lifestyle (HL) or Sustainable Lifestyle (SL).
All participants will complete web-based questionnaires including background information about weight, height, diet, physical activity, smoking, education and other relevant background variables at the beginning of the study as well as at the end of the study. Participants will attend separate group-based workshops 6 times during the 8-week intervention period held by trained personnel. During these workshops, participants will be guided by education, food provision, and assistance to identify facilitators and barriers to a healthy or sustainable lifestyle. In addition, adherence to a healthy or sustainable lifestyle will be reinforced using a behavioral support package provided through a digital platform during the intervention period.
We will compare baseline, midpoint, and final (i.e. week 0, 4 and 8) nutrient intake, CO2e, and the dietary sustainability score for the two diets with an ANOVA model. We assume a dropout rate of 10-15% after baseline assessment (based on our previous pilot study from the fall of 2017) Climate Friendly and Ecological Food on Microbiota (CLEAR). Therefore, we will recruit 47 people to each group to have at least 40 at the end of the study. With 40 participants in each group, this analysis has >90% power to detect a 50% reduction in CO2e for the intervention group. To gain further insight into the development of intake of nutrients, CO2e, and the dietary sustainability score during the follow-up, we will use linear mixed models, with individual-specific baseline trajectories. Moreover, we will perform substitution analyses, i.e. scenarios where a number of meals high in CO2e are substituted for meals low in CO2e. Statistical analyses will be done in R-statistics.
- Conditions
- Healthy Lifestyle, Healthy Diet
- Being tested
- Sustainable lifestyle, Healthy lifestyle
- Keywords
- Sustainability, Physical activity, Active transportation, Dietary fiber, Organic food
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainable lifestyleBehavioural
To encourage and nudge a sustainable lifestyle in an office context in order to improve public health and combat climate change.
Healthy lifestyleBehavioural
To encourage and nudge a healthy lifestyle in an office context, the participants in this arm will function as a control group receiving general recommendations based on NNR 2014 nutritional recommendations and WHO physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyle group (HL) | Active comparator | The control group will receive advice about a conventional healthy diet according to the Nordic Nutrition Recommendations (NNR 2014) and international physical activity recommendations from WHO. The participants will get information about the recommended distribution of energy from macronutrients i.e. energy coming from fat, protein, and carbohydrates, as well as general recommendations about the "plate model", i.e. the combination of food on the plate to adhere to the recommended nutrient intake. Additionally, they will receive instructions to increase physical activity to reach 150 to 300 minutes of moderate aerobic activity per week or the equivalent vigorous activity. Receives: Behavioral: Healthy lifestyle |
| Sustainable lifestyle group (SL) | Experimental | The sustainable lifestyle group will receive instructions to increase the consumption of healthy organic plant-based foods that is carbon or environmentally friendly (i.e. fruits, vegetables, legumes, multigrain cereals, or labeled foods) and decrease consumption of beef and dairy products. We expect that the reduction of diet-related CO2e will be 50% as compared to the baseline, while the intake of nutrients such as fiber, vitamin C, and folate will increase. Additionally, they will receive instructions to increase active and emission-free transportation, i.e. walking and biking to and from work and meetings. Receives: Behavioral: Sustainable lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dietary patterns and intake of fruit and vegetable
Assessment of dietary patterns by the food-frequency questionnaire Meal-Q, expressed as servings per day or grams per day of meat, dairy products, fruit and vegetable.
Measured: Baseline, after 4 weeks and after 8 weeks.
Change from baseline in dietary carbon dioxide equivalents
Assessment of dietary Carbon dioxide equivalents (CO₂e) by converting data from Meal-Q to a daily intake of 50 nutrients by linkage to the National Food Composition Table as well as to a database with Life cycle assessment (LCA) data for 65 different food products to calculate greenhouse gas emissions CO₂e per day.
Measured: Baseline, after 4 weeks and after 8 weeks.
Change in physical activity level
Assessment of physical activity by the self-administrated Web-based questionnaire Active-Q, expressed as metabolic equivalent of task value (MET).
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in concentration of urinary pesticide residues in urine
Assessment of sustainable and organic food intake by measuring concentration of pesticide residues. Samples will be collected at two occasions; baseline (reference sample), and at the end (after 8 weeks) in 50ml FALCON polypropylene containers and stored at -80˚C until further analysis according to gold standard methods. The results will be calculated as μg pesticide/g creatinine to adjust for differences in urinary concentration.
Measured: Baseline, and after 8 weeks.
Secondary outcomes (26)
Changes in dietary sustainability score
Assessment of how the participants lifestyle correlate with the dietary sustainability score that we have developed. The score integrates measures of 14 factors related to lifestyle and sustainability, i.e. CO2e values.
Measured: Baseline, after 4 weeks and after 8 weeks
Changes in the anthropometrical assessments (Body Mass Index)
Bodyweight (kg) and height (cm) measured using standardized procedures and equipment, including a stadiometer and bioelectrical impedance analysis. These measurements will be combined to calculate the Body Mass Index (BMI), which is reported in kg/m².
Measured: Baseline, and after 8 weeks.
Stanford healthy Neighborhood Discovery Tool
An app that participants use to document factors that facilitate or hinder the participants from having a healthy or sustainable lifestyle to and from work and at work. The data consist of geo-coded photographs, text and audio narratives, and data on positive or negative attributes of the workplace (portrayed as a happy and sad smiley face in the app).
Measured: Week 6, workshop number 5 of 6.
Experiences related to a healthy and sustainable lifestyle intervention
A web-based questionnaire that includes questions about what the participants think of the diet "likeability" that they have been assigned to and whether they may consider continuing eating according to the instructions after the study ends, and what potential obstacles they may have encountered.
Measured: Week 8, workshop number 6 of 6.
Changes in intake of energy
Assessment of changes in intake of energy in kilojoule/day (kJ/day) when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of energy in kJ by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of protein
Assessment of changes changes in intake of protein in (g/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of protein in kJ by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of fat
Assessment of changes in intake of fat in (kJ/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of fat in kJ by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of carbohydrates
Assessment of changes in intake of carbohydrates in (kJ/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of macronutrients in kJ by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of dietary fiber
Assessment of changes in intake of dietary fiber in (kJ/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of dietary fiber in kJ by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin A
Assessment of changes in intake of vitamin A, measured in Retinol Equivalents per day (RE/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin A in RE by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin D
Assessment of changes in intake of vitamin D, measured in micrograms per day (μg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin D in μg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of thiamin
Assessment of changes in intake of thiamin, measured in milligrams per day (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of thiamin in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of riboflavin
Assessment of changes in intake of riboflavin, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of riboflavin in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of niacin
Assessment of changes in intake of niacin, measured in Niacin Equivalents per day (NE/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of niacin in NE by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin B6
Assessment of changes in intake of vitamin B6, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B6 in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of folate
Assessment of changes in intake of folate, measured in (μg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of folate in μg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin B12
Assessment of changes in intake of vitamin B12, measured in (μg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin B12 in μg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin C
Assessment of changes in intake of vitamin C, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin C in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of calcium
Assessment of changes in intake of vitamin C, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of vitamin C in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of phosphorus
Assessment of changes in intake of phosphorus, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of phosphorus in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of potassium
Assessment of changes in intake of potassium, measured in grams per day (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of potassium in g by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of iron
Assessment of changes in intake of iron, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iron in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of zinc
Assessment of changes in intake of zinc, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of zinc in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of iodine
Assessment of changes in intake of iodine, measured in (μg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of iodine in μg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in potassium
Assessment of changes in intake of selenium, measured in (μg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of selenium in μg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of copper
Assessment of changes in intake of copper, measured in (mg/day), when the participants shifts their diet from baseline to a healthy or sustainable lifestyle, using a validated food frequency questionnaire called Meal-Q. Questionnaire responses will be converted to daily intake of copper in mg by linkage to the National Food Composition Table using the NutriCalc program.
Measured: Baseline, after 4 weeks and after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start4 Oct 2022
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel cluster randomized trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Environmental Research Institute (IVL)
- Responsible party
- Sponsor
- Investigators
- Katarina Bälter, PhD, Principal investigator, Mälardalen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698094
- Sponsor's protocol ID
- 1-2020/0244
- Acronym
- SOFIA
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Glympi A, Chasioti A, Balter K. Dietary Interventions to Promote Healthy Eating among Office Workers: A Literature Review. Nutrients. 2020 Dec 7;12(12):3754. doi: 10.3390/nu12123754.
PubMed 33297328Balter K. The importance of considering both nutrient quality and climate impact to support sustainable development. Am J Clin Nutr. 2021 Aug 2;114(2):412-413. doi: 10.1093/ajcn/nqab167. No abstract available.
PubMed 34091673Halling Ullberg O, Tillander A, Balter K. A Sustainable Lifestyle Intervention Among Office Workers: Cluster Randomized Pilot and Feasibility Study. JMIR Form Res. 2026 May 7;10:e82061. doi: 10.2196/82061.
PubMed 42096679
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Sustainable Lifestyle on Dietary Quality, CO2e Emissions and Physical Activity in Office Workers: a Study Protocol for a Cluster Randomized Controlled Trial (SOFIA Project)
- ClinicalTrials.gov ID
- NCT06698094
- Acronym / sponsor ID
- SOFIA / 1-2020/0244
- Conditions
- Healthy Lifestyle, Healthy Diet
- Keywords
- Sustainability, Physical activity, Active transportation, Dietary fiber, Organic food
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Collaborators
- Swedish Environmental Research Institute (IVL)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the study, Sustainable Office Intervention (SOFIA), is to promote and ease the adoption of a sustainable lifestyle within an office environment, with the dual goals of enhancing public health and mitigating the adverse effects of climate change. Specifically, the study aims to assess the effectiveness of promoting sustainable lifestyle choices in the office workplace compared to promoting a conventional healthy lifestyle in regards to diet and physical activity.
Detailed description
The participants will be recruited at companies in the Swedish office sector, and after recruitment and baseline assessment, the participants will be randomly assigned to one of two groups Healthy Lifestyle (HL) or Sustainable Lifestyle (SL).
All participants will complete web-based questionnaires including background information about weight, height, diet, physical activity, smoking, education and other relevant background variables at the beginning of the study as well as at the end of the study. Participants will attend separate group-based workshops 6 times during the 8-week intervention period held by trained personnel. During these workshops, participants will be guided by education, food provision, and assistance to identify facilitators and barriers to a healthy or sustainable lifestyle. In addition, adherence to a healthy or sustainable lifestyle will be reinforced using a behavioral support package provided through a digital platform during the intervention period.
We will compare baseline, midpoint, and final (i.e. week 0, 4 and 8) nutrient intake, CO2e, and the dietary sustainability score for the two diets with an ANOVA model. We assume a dropout rate of 10-15% after baseline assessment (based on our previous pilot study from the fall of 2017) Climate Friendly and Ecological Food on Microbiota (CLEAR). Therefore, we will recruit 47 people to each group to have at least 40 at the end of the study. With 40 participants in each group, this analysis has >90% power to detect a 50% reduction in CO2e for the intervention group. To gain further insight into the development of intake of nutrients, CO2e, and the dietary sustainability score during the follow-up, we will use linear mixed models, with individual-specific baseline trajectories. Moreover, we will perform substitution analyses, i.e. scenarios where a number of meals high in CO2e are substituted for meals low in CO2e. Statistical analyses will be done in R-statistics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A two-arm parallel cluster randomized trail
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyle group (HL) | Active comparator | Behavioral: Healthy lifestyleThe control group will receive advice about a conventional healthy diet according to the Nordic Nutrition Recommendations (NNR 2014) and international physical activity recommendations from WHO. The participants will get information about the recommended distribution of energy from macronutrients i.e. energy coming from fat, protein, and carbohydrates, as well as general recommendations about the "plate model", i.e. the combination of food on the plate to adhere to the recommended nutrient intake. Additionally, they will receive instructions to increase physical activity to reach 150 to 300 minutes of moderate aerobic activity per week or the equivalent vigorous activity. |
| Sustainable lifestyle group (SL) | Experimental | Behavioral: Sustainable lifestyleThe sustainable lifestyle group will receive instructions to increase the consumption of healthy organic plant-based foods that is carbon or environmentally friendly (i.e. fruits, vegetables, legumes, multigrain cereals, or labeled foods) and decrease consumption of beef and dairy products. We expect that the reduction of diet-related CO2e will be 50% as compared to the baseline, while the intake of nutrients such as fiber, vitamin C, and folate will increase. Additionally, they will receive instructions to increase active and emission-free transportation, i.e. walking and biking to and from work and meetings. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Preform office work ≤20 hours/week
Key exclusion criteria (3 listed)
- Allergies excluding large food groups
- Visual or speech disability
- Not owning a smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustainable lifestyleTo encourage and nudge a sustainable lifestyle in an office context in order to improve public health and combat climate change. | Behavioural | Sustainable lifestyle group (SL) |
| Healthy lifestyleTo encourage and nudge a healthy lifestyle in an office context, the participants in this arm will function as a control group receiving general recommendations based on NNR 2014 nutritional recommendations and WHO physical activity recommendations. | Behavioural | Healthy lifestyle group (HL) |
Primary outcome
Change in dietary patterns and intake of fruit and vegetable
Time frame: Baseline, after 4 weeks and after 8 weeks.
Assessment of dietary patterns by the food-frequency questionnaire Meal-Q, expressed as servings per day or grams per day of meat, dairy products, fruit and vegetable.
Change from baseline in dietary carbon dioxide equivalents
Time frame: Baseline, after 4 weeks and after 8 weeks.
Assessment of dietary Carbon dioxide equivalents (CO₂e) by converting data from Meal-Q to a daily intake of 50 nutrients by linkage to the National Food Composition Table as well as to a database with Life cycle assessment (LCA) data for 65 different food products to calculate greenhouse gas emissions CO₂e per day.
Change in physical activity level
Time frame: Baseline, after 4 weeks and after 8 weeks.
Assessment of physical activity by the self-administrated Web-based questionnaire Active-Q, expressed as metabolic equivalent of task value (MET).
Changes in concentration of urinary pesticide residues in urine
Time frame: Baseline, and after 8 weeks.
Assessment of sustainable and organic food intake by measuring concentration of pesticide residues. Samples will be collected at two occasions; baseline (reference sample), and at the end (after 8 weeks) in 50ml FALCON polypropylene containers and stored at -80˚C until further analysis according to gold standard methods. The results will be calculated as μg pesticide/g creatinine to adjust for differences in urinary concentration.
26 secondary outcomes
Changes in dietary sustainability score
Time frame: Baseline, after 4 weeks and after 8 weeks
Changes in the anthropometrical assessments (Body Mass Index)
Time frame: Baseline, and after 8 weeks.
Stanford healthy Neighborhood Discovery Tool
Time frame: Week 6, workshop number 5 of 6.
Experiences related to a healthy and sustainable lifestyle intervention
Time frame: Week 8, workshop number 6 of 6.
Changes in intake of energy
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of protein
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of fat
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of carbohydrates
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of dietary fiber
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin A
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin D
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of thiamin
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of riboflavin
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of niacin
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin B6
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of folate
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin B12
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of vitamin C
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of calcium
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of phosphorus
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of potassium
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of iron
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of zinc
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of iodine
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in potassium
Time frame: Baseline, after 4 weeks and after 8 weeks.
Changes in intake of copper
Time frame: Baseline, after 4 weeks and after 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 33297328Glympi A, Chasioti A, Balter K. Dietary Interventions to Promote Healthy Eating among Office Workers: A Literature Review. Nutrients. 2020 Dec 7;12(12):3754. doi: 10.3390/nu12123754.
- Background: PubMed 34091673Balter K. The importance of considering both nutrient quality and climate impact to support sustainable development. Am J Clin Nutr. 2021 Aug 2;114(2):412-413. doi: 10.1093/ajcn/nqab167. No abstract available.
- Derived from this study: PubMed 42096679Halling Ullberg O, Tillander A, Balter K. A Sustainable Lifestyle Intervention Among Office Workers: Cluster Randomized Pilot and Feasibility Study. JMIR Form Res. 2026 May 7;10:e82061. doi: 10.2196/82061.
- Official swedish project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Bälter, PhD principal investigator
Mälardalen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainable lifestyle and Healthy lifestyle in people with Healthy Lifestyle and Healthy Diet, run by Mälardalen University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary patterns and intake of fruit and vegetable (time frame: Baseline, after 4 weeks and after 8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698094, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.