Extending health examination and lifestyle health dialogue in primary care with a digital multiple health behaviour change intervention
| ISRCTN | ISRCTN18001653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18001653 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 09/01/2023
- Registration date
- 11/01/2023
- Last edited
- 21/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Behavioural risk factors, such as harmful alcohol consumption, unhealthy diets, insufficient physical activity, and smoking, contribute to about a third of global disability-adjusted life years and are leading causes of non-communicable diseases (NCDs), including heart disease, lung disease, cancer and diabetes. The World Health Organization has determined that reducing the prevalence of behavioural risk factors should be a priority in many societies to reduce the incidence of NCDs and disability-adjusted life years. It is therefore important to establish effective and scalable means of helping individuals to improve their health behaviours.
Who can participate?
Patients aged 40, 50 and 60 years old who participated in a face-to-face health dialogue at participating primary healthcare units
What does the study involve?
Participants are randomly allocated to either immediate or delayed access to a digital behaviour change intervention. The intervention lasts for 4 months. Questionnaires are sent to all participants throughout the 6-month trial period.
What are the possible benefits and risks of participating?
Improving one's health behaviours prevents disease, and access to the digital intervention is hoped to help individuals change their behaviour. The main risk is that the intervention does not have the desired effects, and can therefore be demotivating for those who were hoping to get help.
Where is the study run from?
Linköping University (Sweden)
When is the study starting and how long is it expected to run for?
January 2021 to March 2026
Who is funding the study?
1. The Swedish Cancer Society (Sweden)
2. The Swedish Research Council for Health, Working Life and Welfare (Sweden)
Who is the main contact?
Dr Marcus Bendtsen
marcus.bendtsen@liu.se
Contact information
Scientific
Linköping university
Linköping
581 83
Sweden
 ORCID ID |
0000-0002-8678-1164 |
|---|---|
| Phone | +46 (0)13 28 10 00 |
| marcus.bendtsen@liu.se |
Study information
| Study design | Parallel-group single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel 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 | A randomized controlled trial of a digital multiple health behaviour change intervention extending health examination and lifestyle health dialogue among primary care patients |
| Study acronym | Coach-PV |
| Study hypothesis | A digital multiple health intervention improves health behaviours (alcohol, physical activity, diet, and smoking) when used as an extension to face-to-face health promotion within primary care, in comparison with no extended intervention. The primary objectives of the study are to: 1. Estimate the effects of a digital multiple health intervention on individual health behaviours: 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 2. Estimate the degree to which the effects of the intervention are mediated through perceived importance, confidence, and know-how. 3. Evaluate the cost versus consequences of extending face-to-face health promotion within primary with a digital health intervention |
| Ethics approval(s) | Approved 11/10/2022, the Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46 (0)104750800; registrator@etikprovning.se), ref: 2022-04776-01 |
| Condition | Improved health behaviours in primary health care patients |
| Intervention | Randomisation will be fully automated and computerised. Block randomisation will be used to allocate participants to the two conditions (random block sizes of 2 and 4). Neither research personnel nor participants will be able to influence allocation. Participants are randomly allocated to either immediate or delayed access to a digital behaviour change intervention. The intervention lasts for 4 months. Questionnaires are sent to all participants throughout the 6-month trial period. The digital intervention, which is called Coach Primary Care, is accessed using a mobile phone. The intervention is designed around social cognitive theories of behaviour change, with a focus on modifying environment, intention, and skills. The intervention’s components 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. The intervention materials can be accessed at participants’ discretion over a 4-month period, and each Sunday afternoon participants will receive a text message with a link and a reminder to access the intervention materials. |
| Intervention type | Behavioural |
| Primary outcome measure | All outcomes are measured using questionnaires at 2, 4, and 6 months post-randomization: 1. Alcohol: Weekly alcohol consumption will be assessed by asking participants the number of standard drinks of alcohol they consumed last week (short-term recall method). The frequency of heavy episodic drinking will be assessed by asking participants how many times they have consumed 4/5 (female/male) or more standard drinks of alcohol on one occasion in the past month. 2. Diet: Average daily consumption of fruit and vegetables will be measured utilising a questionnaire based on the previously published questionnaire by the National Board of Health and Welfare in Sweden, and was further modified to also include portion sizes. The consumption of fruit and vegetables will be measured using two questions concerning the number of portions (100 g) of fruit and vegetables (respectively) the participants ate on average per day during the past week. 3. Physical activity: Weekly moderate to vigorous physical activity (MVPA) will be estimated by summing responses to two questions regarding the number of minutes spent on moderate and vigorous physical activity, respectively, during the past week. 4. Smoking: Four-week point prevalence of smoking abstinence (number of cigarettes in the past 4 weeks) will be asked as a binary question. |
| Secondary outcome measures | All secondary outcomes are measured using questionnaires at 2, 4, and 6 months post-randomization: 1. Perceived stress assessed using the short form perceived stress scale (PSS-4) 2. Weekly consumption of sugary drinks measured by a question regarding the number of units (33 cl) of sugary drinks participants consumed the past week 3. Weekly consumption of candy and snacks measured using a single question regarding number of servings consumed last week 4. Body mass index (BMI) measured by asking participants to report their weight and height 5. Weekly number of cigarettes smoked: Participants who have smoked any cigarette the past four weeks will be asked for the number of cigarettes smoked in the past week 6. Quality of life (QoL) measured using PROMIS Global 10 |
| Overall study start date | 01/01/2021 |
| Overall study end date | 01/03/2026 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | A Bayesian group sequential design will be used, thus no fixed target exists. The researchers has set an upper bound of 2600 participants, but there are target posterior probabilities that will dictate this. Please see study protocol |
| Participant inclusion criteria | Individuals aged 40, 50 and 60 years old, living in the county of Östergötland (in the south-east part of Sweden) will be invited to a health dialogue with a healthcare professional at their primary healthcare clinic. Participants will be recruited from approximately 30 primary healthcare clinics. After completing the health dialogue, all individuals will be given brief verbal information about the Coach Primary Care study. 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 is in Sweden 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 in the past month 3. Fruit and vegetables: Consumed less than 500 grams 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 in the past week |
| Participant exclusion criteria | 1. 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 |
| Recruitment start date | 20/01/2023 |
| Recruitment end date | 01/09/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
58183
Sweden
Sponsor information
University/education
Linköping University
Linköping
58183
Sweden
| Phone | +46 (0)13 281000 |
|---|---|
| infocenter@liu.se | |
| Website | https://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
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an open-access, high-impact, peer-reviewed journal |
| IPD sharing plan | Data will be made available to researchers upon reasonable request, after approval of a research proposal and signing of data transfer agreements, from Marcus Bendtsen (marcus.bendtsen@liu.se), including responses to questionnaires (anonymized) from 2026 onwards. Consent is obtained from all participants. Any request for data must first have been approved by The Swedish Ethical Review Authority. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/01/2023 | No | No | ||
| Statistical Analysis Plan | 13/01/2023 | No | No |
Additional files
Editorial Notes
21/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 20/01/2025 to 01/09/2025.
2. The overall study end date was changed from 01/06/2025 to 01/03/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2026.
13/01/2023: Protocol and statistical analysis plan uploaded (not peer reviewed). The target number of participants was changed from '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' to 'A Bayesian group sequential design will be used, thus no fixed target exists. The researchers has set an upper bound of 2600 participants, but there are target posterior probabilities that will dictate this. Please see study protocol'.
10/01/2023: Trial's existence confirmed by the Swedish Ethical Review Authority.
