NCT06698094

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 4, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4.2 years

First QC Date

August 8, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

SustainabilityPhysical activityActive transportationDietary fiberOrganic food

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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.

    Baseline, and after 8 weeks.

Secondary Outcomes (26)

  • Changes in dietary sustainability score

    Baseline, after 4 weeks and after 8 weeks

  • Changes in the anthropometrical assessments (Body Mass Index)

    Baseline, and after 8 weeks.

  • Stanford healthy Neighborhood Discovery Tool

    Week 6, workshop number 5 of 6.

  • Experiences related to a healthy and sustainable lifestyle intervention

    Week 8, workshop number 6 of 6.

  • Changes in intake of energy

    Baseline, after 4 weeks and after 8 weeks.

  • +21 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Sustainable lifestyle

Interventions

To encourage and nudge a sustainable lifestyle in an office context in order to improve public health and combat climate change.

Sustainable lifestyle group (SL)

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.

Healthy lifestyle group (HL)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Preform office work ≤20 hours/week

You may not qualify if:

  • Allergies excluding large food groups
  • Visual or speech disability
  • Not owning a smartphone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mälardalen University

Västerås, Västmanland County, 72221, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 33297328BACKGROUND
  • Balter 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.

    PMID: 34091673BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Katarina Bälter, PhD

    Mälardalen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be recruited without knowledge of differences between the two arms, and cluster randomized based on there working space (office) with allocation concealment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two-arm parallel cluster randomized trail
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

November 20, 2024

Study Start

October 4, 2022

Primary Completion (Estimated)

December 24, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations