Promotion of Healthy Lifestyle Habits in a Primary Care Setting

March 8, 2024 updated by: Örebro University, Sweden
Intervention aiming to promote healthy dietary and physical activity behaviors in adults with low socio-economic position in a primary health care setting

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Örebro, Sweden, 70182
        • Recruiting
        • Örebro University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: Standard care
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
Time Frame: Before ; at 16 weeks; at 24 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)
Before ; at 16 weeks; at 24 months
Change in plasma triglycerides level
Time Frame: Before ; at 16 weeks; at 24 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)
Before ; at 16 weeks; at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: Before ; at 16 weeks; at 24 months
waist circumference (cm) assessed by a steel tape
Before ; at 16 weeks; at 24 months
Change in systolic and diastolic blood pressure
Time Frame: Before ; at 16 weeks; at 24 months
measured manually with a mercury sphygmomanometer
Before ; at 16 weeks; at 24 months
Change in HDL-cholesterol level
Time Frame: Before ; at 16 weeks; at 24 months
plasma High density lipoprotein- cholesterol: assessed using chemistry kits from Ortho-Clinical
Before ; at 16 weeks; at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

December 31, 2026

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)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Varberga

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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