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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in dietary patterns and intake of fruit and vegetable
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be recruited without knowledge of differences between the two arms, and cluster randomized based on there working space (office) with allocation concealment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preform office work ≤20 hours/week
排除标准
- •Allergies excluding large food groups
- •Visual or speech disability
- •Not owning a smartphone.
结局指标
主要结局
Change in dietary patterns and intake of fruit and vegetable
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Changes in intake of protein(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of fat(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of carbohydrates(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of dietary fiber(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of vitamin A(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of vitamin D(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of thiamin(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of riboflavin(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of niacin(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of vitamin B6(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of folate(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of vitamin B12(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of vitamin C(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of calcium(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of phosphorus(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of potassium(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of iron(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of zinc(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of iodine(Baseline, after 4 weeks and after 8 weeks.)
- Changes in potassium(Baseline, after 4 weeks and after 8 weeks.)
- Changes in intake of copper(Baseline, after 4 weeks and after 8 weeks.)