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Extending health examination and lifestyle health dialogue in primary care with a digital multiple health behaviour change intervention

A randomized controlled trial of a digital multiple health behaviour change intervention extending health examination and lifestyle health dialogue among primary care patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18001653
Enrollment
2600
Registered
2023-01-11
Start date
2023-01-20
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improved health behaviours in primary health care patients Other

Interventions

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

Sponsors

Linköping University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026