Clinical trial NCT06698094: Sustainable Office Intervention, Impact of a Sustainable Lifestyle on Diet, Physical Activity and Carbon Footprint
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Lifestyle
Healthy Diet
Keywords: Sustainability
Physical activity
Active transportation
Dietary fiber
Organic food
Lead sponsor: Mälardalen University
Sponsor class: OTHER
Collaborators: name: Swedish Environmental Research Institute (IVL)
First posted: 2024-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel cluster randomized trail
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

- Preform office work ≤20 hours/week

Exclusion Criteria:

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

Primary outcomes:
measure: Change in dietary patterns and intake of fruit and vegetable
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Change from baseline in dietary carbon dioxide equivalents
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Change in physical activity level
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in concentration of urinary pesticide residues in urine
timeFrame: Baseline, and after 8 weeks.
Secondary outcomes:
measure: Changes in dietary sustainability score
timeFrame: Baseline, after 4 weeks and after 8 weeks
measure: Changes in the anthropometrical assessments (Body Mass Index)
timeFrame: Baseline, and after 8 weeks.
measure: Stanford healthy Neighborhood Discovery Tool
timeFrame: Week 6, workshop number 5 of 6.
measure: Experiences related to a healthy and sustainable lifestyle intervention
timeFrame: Week 8, workshop number 6 of 6.
measure: Changes in intake of energy
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of protein
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of fat
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of carbohydrates
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of dietary fiber
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of vitamin A
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of vitamin D
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of thiamin
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of riboflavin
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of niacin
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of vitamin B6
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of folate
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of vitamin B12
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of vitamin C
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of calcium
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of phosphorus
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of potassium
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of iron
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of zinc
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of iodine
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in potassium
timeFrame: Baseline, after 4 weeks and after 8 weeks.
measure: Changes in intake of copper
timeFrame: Baseline, after 4 weeks and after 8 weeks.
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Mälardalen University
state: Västmanland
Study officials:
affiliation: Mälardalen University
name: Katarina Bälter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.