A digital intervention to support healthy lifestyle behaviours among online help seekers
| ISRCTN | ISRCTN16420548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16420548 |
| Secondary identifying numbers | 20 0883 Pj |
- Submission date
- 25/09/2021
- Registration date
- 05/10/2021
- Last edited
- 23/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Noncommunicable diseases (NCDs), such as heart disease and cancer, are a major public health concern and cause 71% of deaths globally each year. The World Health Organization (WHO) has made it clear that the burden of disease that NCDs cause would be greatly reduced if the prevalence of harmful alcohol consumption, unhealthy diets, physical inactivity, and smoking was reduced. Thus, it is important to find effective and scalable means of helping individuals to improve their lifestyle behaviours to improve health and well-being.
Recent data indicate that 16% of the adult population of Sweden are risky drinkers, 7% are smokers, 36% have an inadequate level of physical activity, and 51% are overweight or obese. Despite one in three cancer cases being preventable by a healthy lifestyle, these rates have not markedly decreased over the past 15 years, with the exception of smoking. More needs to be done to help individuals change their lifestyle to reduce the incidence of cancer and other NCDs. Also, since unhealthy behaviours interact (e.g. excessive alcohol consumption may lead to weight gain), and risks are multiplicative, it is important to support the change of multiple behaviours.
The main aim of this study is to estimate the effects of the components of a new digital intervention targeting multiple lifestyle behaviours (alcohol, diet, physical activity, and smoking) among people in Sweden who are looking for help online.
Who can participate?
Adults in Sweden who have at least one behaviour classified as risky (e.g. heavy drinking, poor diet, low physical activity, smoking)
What does the study involve?
Participation involves answering questionnaires and being given access to a digital intervention on a mobile phone. Participants are randomly allocated to different combinations of modules. The intervention is 4 months with follow-ups at 2 and 4 months.
What are the possible benefits and risks of participating?
The benefits of participating include access to a new intervention designed to help participants change their lifestyle behaviour for the better, which will have positive health consequences. Risks include being disappointed or feeling de-motivated if the support given does not suit one's needs.
Where is the study run from?
Linköping University (Sweden)
When is the study starting and how long is it expected to run for?
May 2020 to March 2024
Who is funding the study?
Swedish Cancer Society (Sweden)
Who is the main contact?
Dr Marcus Bendtsen
marcus.bendtsen@liu.se
Contact information
Scientific
Linköping University
Linköping
58183
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|---|
| Phone | +46 (0)13286975 |
| marcus.bendtsen@liu.se |
Study information
| Study design | Double-blind randomized factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized factorial trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Multiple lifestyle behaviour digital intervention targeting online help seekers: a randomised factorial trial |
| Study objectives | The study aims to: 1. Estimate the effects of a novel digital intervention’s different components on individual lifestyle behaviours Primary: 1.1. Weekly alcohol consumption and number of episodes per month of heavy drinking 1.2. Average daily fruit and vegetable consumption 1.3. Weekly moderate to vigorous physical activity 1.4. Four-week point prevalence of smoking Secondary: 1.5. Health-related quality of life (HRQoL) 1.6. Perceived stress 1.7. Weekly consumption of candy and snacks 1.8. Weekly consumption of sugary drinks 1.9. Body mass index (BMI) 1.10. Number of cigarettes smoked the past week 2. Estimate the degree to which the effects of the components are mediated through perceived importance, confidence, and know-how 3. Detect interactions among lifestyle behaviour change, e.g., those who stop smoking may also reduce their alcohol consumption, and the degree to which this is moderated by the components of the intervention 4. Investigate the perceived usefulness and general opinion of the support received in contrast to factorial allocation 5. Conduct a health economic evaluation of the intervention's components |
| Ethics approval(s) | Approved 15/12/2020, Swedish Ethical Review Authority (Etikprövningsmyndigheten, FE 111 20, 838 82 Frösön, Sweden; +46 (0)10-475 08 00; registrator@etikprovning.se), ref: Dnr 2021-02855 |
| Health condition(s) or problem(s) studied | Lifestyle behaviour change among adults who are seeking help online and who do not follow national guidelines |
| Intervention | The digital intervention consists of a set of modules that users access using their mobile phones. The modules are intended to be used as a toolbox, allowing users to choose which parts of the intervention to interact with and tailor the support to their needs. Each Sunday afternoon, participants will receive a text message with a link and a reminder to access and engage with the intervention materials. Below, the six modules of the intervention are briefly described, which will also represent the factors in the factorial trial. Each participant recruited to the trial will be randomly allocated by block randomisation with random block sizes of 64 and 128 to one of 64 conditions, each condition representing a combination of available/not-available of the modules. The intervention is 4 months with follow-ups at 1, 2 and 4 months. MODULE 1: SCREENING AND FEEDBACK The first module consists of screening and feedback. When pressing the link in the weekly text message, participants will be asked to respond to a questionnaire regarding their current lifestyle behaviours, after which they are shown feedback on their current behaviour in contrast to national guidelines. They will subsequently be given access to the rest of the modules appropriate for their randomised allocation. Self-monitoring has been shown to be a potentially effective strategy for reducing excessive alcohol consumption and promoting healthy eating and physical activity. MODULE 2: GOAL SETTING AND SELF-REGULATION The second module supports enhanced self-regulatory capacity and skills via goal setting and planning. This includes setting goals for future behaviour (and receiving feedback on previous set goals), preparing for triggers, and accepting ready-made habit challenges. Intervention content designed around goalsetting, action planning, practising behaviour and habit formation has, amongst other planning-related activities, been shown to be important among effective lifestyle interventions. Participants will be reminded of the goals that they have set, including any habit challenges they have accepted, via text message prompts throughout the week. MODULE 3: MOTIVATION AND SELF-EFFICACY The third module aims to increase users’ awareness of their own motivation, prompt commitment, and boost motivation and self-efficacy. This is supported via texts, videos and exercises relating to health, economics and motivation awareness. Digital behaviour change interventions have been shown to have the capacity to increase self-efficacy, however, there is a lack of consensus across reviews with regards to which content works to facilitate this increase. The module will also allow participants to sign up for text messages with motivational content sent to them throughout the week. The content of the messages has been derived from previously developed and evaluated interventions. MODULE 4: SKILLS AND KNOW-HOW The fourth module aims to increase the user’s skills and know-how of how to make lasting behavioural changes. This will include concrete tips on how to initiate and maintain change in everyday life. For instance, participants are given strategies they can employ when going to parties where alcohol is served, or how to introduce vegetables to their breakfast. As with the third module, participants will be able to sign up for text messages with tips sent to them throughout the week – the content of which has also been derived from previously developed and evaluated interventions. MODULE 5: MINDFULNESS The fifth module aims to help participants to build the mental resources needed for behaviour change. A set of mindfulness exercises, including guided meditation, will be available in the module. The exercises are based on previous research and are believed to be important to improve the mental well-being of those who engage with them. MODULE 6: SELF-COMPOSED TEXT MESSAGES The sixth module consists of self-composed text messages sent to participants throughout the week. Participants will be allowed to author up to three messages to themselves and have them sent at specified intervals. For instance, a participant can write a message about their commitment to increase their physical activity and decide to have it sent to them every Monday and Wednesday at 5 pm. This type of activity seems under-studied in the literature more widely but has shown preliminary interesting results in an ongoing trial. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Alcohol: 1.1. Weekly alcohol consumption, assessed by asking participants the number of standard drinks of alcohol they consumed last week (short term recall method) at baseline, 2- and 4-months post-randomisation 1.2. Frequency of heavy episodic drinking,e assessed by asking participants how many times they have consumed more than four/five (female/male) standard drinks of alcohol on one occasion the past month at baseline, 2- and 4-months post-randomisation 2. Weekly consumption of fruit and vegetables, assessed by asking two questions regarding how many portions (100 g) of fruit and vegetables (respectively) participants consumed on average per day during the past week at baseline, 2- and 4-months post-randomisation 3. Weekly moderate to vigorous physical activity (MVPA), assessed by summing responses to two questions regarding the number of minutes spent on physical activity the past week ( moderate and vigorous respectively) at baseline, 2- and 4-months post-randomisation 4. Four-week point prevalence of smoking abstinence (no cigarettes the past week), asked as a binary question at baseline, 2- and 4-months post-randomisation |
| Secondary outcome measures | Secondary: 1. Weekly consumption of candy and snacks, assessed by means of questionnaires published by the National Board of Health and Welfare in Sweden, modified to also include portion sizes at 2- and 4-months post-randomisation 2. Consumption of sugary drinks, assessed by asking participants how many units (33 cl) of sugary drinks they consumed the past week at 2- and 4-months post-randomisation 3. Body mass index (BMI), measured by asking participants to report their height and weight at 2- and 4-months post-randomisation 4. Number of cigarettes smoked the past week: participants who have smoked any cigarette the past 4 weeks will be asked for the number of cigarettes smoked the past week at baseline, 2- and 4-months post-randomisation 5. Perceived stress assessed using the short form perceived stress scale (PSS-4) at baseline, 2- and 4-months post-randomisation 6. Quality of Life (QoL) assessed using PROMIS Global 10 v1.2 at 2-months and 4-months post-randomisation Mediators: 1. Importance of change, assessed on a scale from 1 to 10 at baseline, 1-, 2- and 4-months post-randomisation 2. Confidence in one’s ability to change, assessed on a scale from 1 to 10 at baseline, 1-, 2- and 4-months post-randomisation 3. Knowledge of how to change, assessed on a scale from 1 to 10 at baseline, 1-, 2- and 4-months post-randomisation |
| Overall study start date | 01/05/2020 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | A Bayesian group sequential design will be used, thus no fixed target exists. The researchers expect between 1500-2500 participants, but there are target posterior probabilities that will dictate this. |
| Total final enrolment | 5420 |
| Key inclusion criteria | Individuals will be included in the trial if they fulfil at least one of five conditions: 1. Weekly alcohol consumption: Consumed 10/15 (female/male) or more standard drinks of alcohol the past week. A standard drink of alcohol in Sweden is defined as 12 g of pure alcohol 2. Heavy episodic drinking: Consumed 4/5 (female/male) or more standard drinks of alcohol on a single occasion at least once the past month 3. Fruit and vegetables: Consumed less than 500 g of fruit and vegetables on average per day the past week 4. Moderate to vigorous physical activity: Spent less than 150 minutes on moderate to vigorous physical activity the past week 5. Smoking: Having smoked at least one cigarette the past week |
| Key exclusion criteria | 1. Individuals will be explicitly excluded if they do not fulfil any of the criteria or if they are less than 18 years of age 2. The trial information and intervention will be entirely in Swedish and delivered to participants’ mobile phones, thus not comprehending Swedish well enough to sign up or not having access to a mobile phone will implicitly exclude individuals |
| Date of first enrolment | 31/10/2021 |
| Date of final enrolment | 19/10/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
S-58183
Sweden
Sponsor information
University/education
Linköping University
Linköping
S-58183
Sweden
| Phone | +46 (0)13-28 10 00 |
|---|---|
| infocenter@liu.se | |
| Website | https://www.liu.se |
"ROR" |
https://ror.org/05ynxx418 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. A protocol, including a statistical analysis plan, will be registered on the Open Science Framework prior to trial commencement 2. The protocol (with a statistical analysis plan) is also planned to be published in a peer-reviewed journal before enrollment has ended 3. Planned publications in open access peer-reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available in order to comply with GDPR. Data will be held at Linköping University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/07/2022 | 27/07/2022 | Yes | No |
Editorial Notes
23/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2023 to 19/10/2023.
2. The overall end date was changed from 31/03/2024 to 01/03/2024.
3. The total final enrolment was added.
27/07/2022: Publication reference added.
04/10/2021: Trial's existence confirmed by the Swedish Ethical Review Authority.
