Promotion of Healthy Lifestyle Habits in Primary Care Settings

NCT05689762 | Recruiting

• 1 other identifier: PCrorelse
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in waist circumference

  Before ; at 16 weeks; at 12 months

• Change in systolic and diastolic blood pressure

  Before ; at 16 weeks; at 12 months

• Change in HDL-cholesterol level

  Before ; at 16 weeks; at 12 months

• Change in BMI

  Before ; at 16 weeks; at 12months

Study Arms (2)

Health counselling plus E-health platform

EXPERIMENTAL

Receive same information as controls plus health counseling and access to E-health platform

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.

Interventions

Healthy lifestyle counseling and E-health support BEHAVIORAL

Promotion of healthy lifestyle behaviors through counseling and access to E-health platform

Health counselling plus E-health platform

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• overt disease

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, 70182, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 39148346 DERIVED

Study Officials

• Fawzi Kadi, professor

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fawzi Kadi, professor

CONTACT

+4619302160; fawzi.kadi@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 19, 2023
• Study Start: June 22, 2022
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

SE (1)