Healthy LifestylePCrorelseNCT05689762
Promotion of Healthy Lifestyle Habits in Primary Care Settings
A study testing Healthy lifestyle counseling and E-health support in people with Healthy Lifestyle, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Intervention aiming to promote healthy dietary and physical activity behaviors in adults with different socioeconomic status primary care settings Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Healthy lifestyle counseling and E-health support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jun 2022to 10 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age, high metabolic risk- poor lifestyle habits (diet and physical activity)
Who cannot join
- overt disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Örebro University
Örebro, 70182
fawzi Kadi, Phd, 019302160 ext. 0046, fawzi.kadi@oru.se
About this study
Intervention aiming to promote healthy dietary and physical activity behaviors in adults with different socioeconomic status primary care settings
Read the detailed description
The project aims to strengthen primary care's ability to promote healthy eating and physical activity habits among population groups with an elevated risk of disease. Participants will receive health counseling focusing of physical activity and diet and will also have access to a digital platform supporting the adoption of healthy lifestyles. The goals of the project are to (1) implement changes and evaluate their effects on diet quality and physical activity level, (2) evaluate the impact on metabolic risk factors.
- Conditions
- Healthy Lifestyle
- Being tested
- Healthy lifestyle counseling and E-health support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle counseling and E-health supportBehavioural
Promotion of healthy lifestyle behaviors through counseling and access to E-health platform
| Study group | Role | What they receive |
|---|---|---|
| Health counselling plus E-health platform | Experimental | Receive same information as controls plus health counseling and access to E-health platform Receives: Behavioral: Healthy lifestyle counseling and E-health support |
| Control | No intervention | Receive (1) standard care advice based on general health benefits of healthy lifestyle habits (benefits of adherence to national guidelines about physical activity and dietary habits as well as limiting alcohol intake and smoking withdrawal), (2) feedback about current lifestyle habits and health status. Tobacco users and subjects with high alcohol consumption will be referred to specialized care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose level
Blood glucose (mmol/L) assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Measured: Before ; at 16 weeks; at 12 months
Change in plasma triglycerides level
Plasma triglycerides (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Measured: Before ; at 16 weeks; at 12 months
Change in physical activity level
Minutes in moderate to vigorous physical activity
Measured: Before; at 16 weeks; at 12 months
Change in intakes of healthy food items
number of portions of fruits and vegetables
Measured: Before; at 16 weeks; at 12 months
Secondary outcomes (4)
Change in waist circumference
waist circumference (cm) assessed by a steel tape
Measured: Before ; at 16 weeks; at 12 months
Change in systolic and diastolic blood pressure
measured manually with a mercury sphygmomanometer
Measured: Before ; at 16 weeks; at 12 months
Change in HDL-cholesterol level
plasma High density lipoprotein- cholesterol: assessed using chemistry kits from Ortho-Clinical
Measured: Before ; at 16 weeks; at 12 months
Change in BMI
BMI in kg/m2
Measured: Before ; at 16 weeks; at 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start22 Jun 2022
- Primary completion10 Jan 2028 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fawzi Kadi, professor, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689762
- Sponsor's protocol ID
- PCrorelse
- Acronym
- PCrorelse
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2022
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kadi F, Nilsson A. Dynamics of Perceived Barriers to Change Physical Activity and Eating Habits in Adults Before and During a Lifestyle Intervention in a Primary Care Setting: A Mixed Methods Approach. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241273321. doi: 10.1177/21501319241273321.
PubMed 39148346
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Healthy Lifestyle Habits in Primary Care Settings
- ClinicalTrials.gov ID
- NCT05689762
- Acronym / sponsor ID
- PCrorelse / PCrorelse
- Conditions
- Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 10 Jan 2028 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intervention aiming to promote healthy dietary and physical activity behaviors in adults with different socioeconomic status primary care settings
Detailed description
The project aims to strengthen primary care's ability to promote healthy eating and physical activity habits among population groups with an elevated risk of disease. Participants will receive health counseling focusing of physical activity and diet and will also have access to a digital platform supporting the adoption of healthy lifestyles. The goals of the project are to (1) implement changes and evaluate their effects on diet quality and physical activity level, (2) evaluate the impact on metabolic risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health counselling plus E-health platform | Experimental | Behavioral: Healthy lifestyle counseling and E-health supportReceive same information as controls plus health counseling and access to E-health platform |
| Control | No intervention | –Receive (1) standard care advice based on general health benefits of healthy lifestyle habits (benefits of adherence to national guidelines about physical activity and dietary habits as well as limiting alcohol intake and smoking withdrawal), (2) feedback about current lifestyle habits and health status. Tobacco users and subjects with high alcohol consumption will be referred to specialized care. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age, high metabolic risk- poor lifestyle habits (diet and physical activity)
Key exclusion criteria (1 listed)
- overt disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lifestyle counseling and E-health supportPromotion of healthy lifestyle behaviors through counseling and access to E-health platform | Behavioural | Health counselling plus E-health platform |
Primary outcome
Change in blood glucose level
Time frame: Before ; at 16 weeks; at 12 months
Blood glucose (mmol/L) assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in plasma triglycerides level
Time frame: Before ; at 16 weeks; at 12 months
Plasma triglycerides (mmol/L) : assessed using chemistry kits from Ortho-Clinical Diagnostics on a Vitros-5.1 analyzer platform (Clinical Diagnostics, Raritan, NJ, United States)
Change in physical activity level
Time frame: Before; at 16 weeks; at 12 months
Minutes in moderate to vigorous physical activity
Change in intakes of healthy food items
Time frame: Before; at 16 weeks; at 12 months
number of portions of fruits and vegetables
4 secondary outcomes
Change in waist circumference
Time frame: Before ; at 16 weeks; at 12 months
Change in systolic and diastolic blood pressure
Time frame: Before ; at 16 weeks; at 12 months
Change in HDL-cholesterol level
Time frame: Before ; at 16 weeks; at 12 months
Change in BMI
Time frame: Before ; at 16 weeks; at 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 39148346Kadi F, Nilsson A. Dynamics of Perceived Barriers to Change Physical Activity and Eating Habits in Adults Before and During a Lifestyle Intervention in a Primary Care Setting: A Mixed Methods Approach. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241273321. doi: 10.1177/21501319241273321.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fawzi Kadi, professor principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle counseling and E-health support in people with Healthy Lifestyle, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fawzi Kadi, professor (+4619302160, fawzi.kadi@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose level (time frame: Before ; at 16 weeks; at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.