Effect of a Nine-Month Web- and App-Based Workplace Intervention to Promote Healthy Lifestyle and Weight Loss for Employees in the Social Welfare and Health Care Sector: A Randomized Controlled Trial

Background General health promoting campaigns are often not targeted at the people who need them the most. Web- and app-based tools are a new way to reach, motivate, and help people with poor health status. Objective The aim of our study was to test a Web- and mobile app-based tool (“SoSu-life”) on employees in the social welfare and health care sector in Denmark. Methods A randomized controlled trial was carried out as a workplace intervention. The tool was designed to help users make healthy lifestyle changes such as losing weight, exercise more, and quit smoking. A team competition between the participating workplaces took place during the first 16 weeks of the intervention. Twenty nursing homes for elderly people in 6 municipalities in Denmark participated in the study. The employees at the nursing homes were randomized either 1:1 or 2:1 on a municipality level to use the SoSu-life tool or to serve as a control group with no intervention. All participants underwent baseline measurements including body weight, waist circumference, body fat percentage, blood pressure, and blood cholesterol level and they filled in a questionnaire covering various aspects of health. The participants were measured again after 16 and 38 weeks. Results A total of 566 (SoSu-life: n=355, control: n=211) participants were included in the study. At 16 weeks there were 369 participants still in the study (SoSu-life: n=227, control: n=142) and 269 participants completed the 38 week intervention (SoSu-life: n=152, control: n=117). At 38 weeks, the SoSu-life group had a larger decrease in body weight (−1.01 kg, P=.03), body fat percentage (−0.8%, P=.03), and waist circumference (−1.8 cm, P=.007) compared with the control group. Conclusions The SoSu-life Web- and app-based tool had a modest yet beneficial effect on body weight and body fat percentage in the health care sector staff. Trial Registration Clinicaltrials.gov NCT02438059; http://clinicaltrials.gov/ct2/show/NCT02438059 (Archived by WebCite at http://www.webcitation.org/6i6y4p2AS)

at the navel to the nearest 0.5 mm with measuring tape. Further, hip circumference was measured horizontally at the widest point between the hip and the buttocks to the nearest 0.5 cm with a measuring tape. Blood pressure was measured with a digital blood pressure device (KIWEX, Automatic Blood Pressure Monitor, Model UA-787 Plus, A&D Medical Japan, Tokyo). Throughout all the measurements, the participants were barefooted, if possible, and wore underwear. Participants were encouraged to fast approximately three hours before the examination, although consumption of water, coffee, or tea was allowed. Time for the last meal was noted if the last meal or drink was consumed less than 360 minutes prior to the examination.

Blood samples
Blood samples were collected using a finger prick test (BIO Microcrotainer, contact-activated Lancet). Glucose was measured with HemoCue Glucose 201 RT, and total cholesterol was measured with Accutrend Plus, COBAS GCTLmmol/L. The glucose levels are not included in the analyses because the manufacturer informed us of a possible error in the micro-cuvettes used for the sampling and analyses glucose in the blood.

Details on the weight loss part of the SoSu-life tool
The weight loss tool is based on a unit system where a specific amount of food is equal to a specific amount of units, based on amounts of calories and nutritional composition. Based on the users' height and weight the daily energy level is calculated and a suggested amount of unit per day is being suggested for weight loss. The user register his or her diet intake and daily exercise and the program gives feedback on the energy balance of the day with a green code for proper energy balance and a red code for too high energy intake.
The SoSu-life tool food registration feature is designed to support healthy eating and/or a weight loss pledge. This feature, called the Unit System was developed by the University of Copenhagen. On the basis of body weight, gender, age, and the specified desired weight loss entered by the study participant while taking the pledge, the program calculates an estimated daily maximum energy intake. The system contains a full food database, where each item is defined by energy units of 250 KJ/unit. An energy unit was added to the daily energy balance as food and drinks, but these units were also subtracted by the amount of physical activity reported. Furthermore, the units had a colour that specified the dominating macronutrient in the foodstuff. The program recommended a certain distribution of colours to obtain the healthiest and most saturating diet. This system allowed the participant to eat the food they prefer during weight loss. Physical activity was registered by registering time and type of activity, and the amount of energy expended was then calculated in units of 250 kJ.

Description of the SoSu-life intervention
The following description of the SoSu-life intervention is a description of the items according to the TIDieR checklist that have not already been described or not been fully described in the main paper. The intervention was developed in 2011 before a TIDieR checklist and guide was available (2014). Therefore it is not possible to answer all items fully but the following description is our best attempt.

Brief name
SoSu-life, a web and app-based workplace health promotion tool to help weight loss and well-being for social and health care workers.

Why. Rationale, theory, or goal of the elements essential to the intervention
By assisting the social and health care workers engage in a health promotion project where group interactions play a very important part they can support each other in creating healthy habit changes both during and outside of working hours. Furthermore, they are provided with a digital tool that can help assist the individual user to achieve weight loss, eat healthier, improve fitness, get a stronger body, quit smoking or decrease number of cigarettes.
A simple model of the idea behind the SoSu-life tool.
The different features and their purpose in the SoSu-life tool are listed below.
The social features -Team competition: When the user solves the challenges given by the program and their colleagues, points are awarded to the team (work) in the competition against all other participating nursing homes. General use of the program is also rewarded with points. During the first 16 weeks of the intervention it was possible to win a prize once a month. After the first 16 weeks the nursing homes that collected the most points won the main prize.
-Weekly assignments: These are weekly tasks to be solved together with colleagues or individually. All participants must solve the same task.
-Colleague Challenges: These are challenges sent from colleague to colleague. The challenges the participants could receive was depending on their own personal pledge.
-Groups: Establishing groups to cultivate communities of interest with colleagues and other users.
-Forums: Free debate on all topics with all users of the program.
The individual features to help support the pledge -Diet: Calorie calculator.
-Smoking cessation: Tool to help cut down on cigarettes or quit smoking.
-Well-being: Tool to enter today's mood.
-My habits: Tool to get inspired to try out new habits.
-SMS help: Tool to receive personal SMS messages with reminders of new habits or other self-selected topics.
-Quick input key: Easy input of daily meals, consumption of fruits and vegetables, water consumption and daily exercise.
-My Status: Statistics on weight development, smoking patterns and well-being.
-Weight and cm: Tool to enter body weight and waist circumference. -Articles: Knowledge, tips and tricks regarding food, exercise, smoking and well-being.

What (materials): Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers.
The intervention group were given access to the SoSu-life website and app (and provided free of charge with a smart phone if the participant did not already own one. The smart phone was blocked, so that it could only access and use the SoSu-life APP). The features are described in item 2 and in the manuscript.
The participants were given a 10-15 minutes personal introduction to the SoSu-life tool from a project team member.
Participants were also provided with a paper pamphlet with a description of the main features of the web and app.
Before signing an informed consent the participant were also given an information folder on the research project.

What (procedures): Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities
The participants received a weekly text message with information on the weekly group assignment and two weekly text messages with tips and tricks depending on the participants' pledge. In the message program in the SoSu-life tool, the participants received information on how to be successful with the use of the tool and updates on how the intervention was progressing. Every month they received an email with a newsletter about who had won the monthly competition and the relevant score in the team competition.
Participant could send a message to counselors regarding use of the program or questions or help regarding how to achieve the goal in their pledge.
The participant could also call a hotline during working hours with questions regarding the tool.

Who provided: For each category of intervention provider (for example, psychologist, nursing assistant), describe their expertise, background and any specific training given
The health examinations were performed by personal from the research group. They were all trained in how to measure all the clinical measures according to standard operating procedures developed for the study. The counsellors answering text questions from the users had a dietitian, smoking cessation consultant or sport trainer background.

How: Describe the modes of delivery (such as face to face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group
See item 3 and 4.

Where: Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features
The study was conducted in six municipalities in Denmark from August 2011 -July 2012. In each municipality two to four nursing homes were randomized to either the SoSu-life tool (called SoSu-life group) or to a control group. The randomization of the participating nursing homes was conducted continually over time within each municipality.
Those municipalities with an even number of nursing homes were randomized in a 1:1 ratio, and municipalities with an odd number of nursing homes in a 2:1 ratio. Twelve of a total of 20 nursing homes were randomized to SoSu-life, and 8 were randomized to control. The randomization was performed in a simple blinded way (simple paper draw) by two of the study investigators and/or in a collaboration between investigators and staff at an initial meeting with local staff in each municipality. Each draw was observed by independent witnesses to observe that it was performed in a fair and unbiased way. The study was divided into two distinct periods for the SoSu-life group: an initial 16 week period including a team competition, and a subsequent 22 week period without a competition. Participants chose a pledge for each period the (Figure 1).

Figure 1. Overview of the SoSu-life study
Participants were recruited August -September 2012 when an information meeting was held at each nursing home during work hours, after which each of the interested employees completed the informed consent form. Eligibility criteria for participation were that the employees had to work under conditions in accordance with a FOA-negotiated agreement.

When and how much: Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose
The participants had access to the tool for nine month. Also see item 4.

Tailoring: If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how
Specific features in the SoSu-life tool was personalized according to pledge: "Colleagues challenges", received text messages, "my habits" and messages in the inbox,

Modifications: If the intervention was modified during the course of the study, describe the changes (what, why, when, and how)
There were no modifications of the intervention during the study period.

How well (planned): If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them
The team competition with the monthly prizes and the main prize after 16 weeks was designed to keep participants motivated to use the SoSu-life tool. The monthly prizes were delivered to the wining nursing home by staff from the project team.

12: How well (actual): If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned
The SoSu-life tool worked as planned during the whole intervention period. 52 % of the participant who initially signed up for the study dropped out. The point system incorporated in the tool was an indication on whether or not the participants used the tool. Figure 1 shows how many point that on average were earned during the intervention period.

Days Average earned points
The figure shows that the use of the tool declined during the intervention period especially after the first 16 weeks (around day 112). Multi-level mixed effect linier regression with municipality as a random effect c Sub-group defined by having weight loss pledge 1 and 2.