Promotion of Healthy Lifestyle Habits in Primary Care Settings (PCrorelse)

Intervention aiming to promote healthy dietary and physical activity behaviors in adults with different socioeconomic status primary care settings

Study Overview

• Status: Recruiting
• Conditions: Healthy Lifestyle
• Intervention / Treatment: Behavioral: Healthy lifestyle counseling and E-health support

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fawzi Kadi, professor; Phone Number: +4619302160; Email: fawzi.kadi@oru.se

Study Locations

• Sweden
  • Örebro, Sweden, 70182
    • Recruiting
    • Örebro University
    • Contact: fawzi Kadi, Phd; Phone Number: 0046 019302160; Email: fawzi.kadi@oru.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age, high metabolic risk- poor lifestyle habits (diet and physical activity)

Exclusion Criteria:

• overt disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health counselling plus E-health platform; Receive same information as controls plus health counseling and access to E-health platform	Behavioral: Healthy lifestyle counseling and E-health support; Promotion of healthy lifestyle behaviors through counseling and access to E-health platform
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Before ; at 16 weeks; at 12 months
Change in physical activity level	Minutes in moderate to vigorous physical activity	Before; at 16 weeks; at 12 months
Change in intakes of healthy food items	number of portions of fruits and vegetables	Before; at 16 weeks; at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference	waist circumference (cm) assessed by a steel tape	Before ; at 16 weeks; at 12 months
Change in systolic and diastolic blood pressure	measured manually with a mercury sphygmomanometer	Before ; at 16 weeks; at 12 months
Change in HDL-cholesterol level	plasma High density lipoprotein- cholesterol: assessed using chemistry kits from Ortho-Clinical	Before ; at 16 weeks; at 12 months
Change in BMI	BMI in kg/m2	Before ; at 16 weeks; at 12months

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Investigators: Principal Investigator: Fawzi Kadi, professor, Örebro University, Sweden

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PCrorelse

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No