Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorVastra Gotaland Region
About this trial
The goal of this clinical trial is to learn if an individualized lifestyle intervention works to improve weight, diet, physical activity, cardiovascular health, health-related quality of life, and cost-effectiveness in overweight and obese adults aged 45-65 years.
The main questions it aims to answer are:
Does the intervention lead to sustained weight loss after 18 months?
Does the intervention improve cardiovascular risk factors, metabolic markers, and health-related quality of life compared to general written advice?
Is the intervention cost-effective?
Researchers will compare the individualized lifestyle intervention to a control group that receives general written advice on physical activity and diet to see if the intervention provides greater long-term health and economic benefits.
Participants will:
Attend counseling sessions with a health promoter Take part in supervised aerobic and resistance training with a physiotherapist Use swimming facilities and participate in the Lifestyle School Access a digital health coach and the online Lifestyle Tool Complete measurements of body weight, diet, physical activity, and cardiovascular health markers (waist-to-hip ratio, blood pressure, blood lipids, fasting glucose, HbA1c, CRP, and liver enzymes) Complete assessments of resting energy expenditure, aerobic fitness, muscle strength, motivation, and health-related quality of life Provide blood samples at baseline, 6 months, and 18 months for dietary biomarker analysis Contribute data for health economic evaluation to assess cost-effectiveness
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 45-65 years at baseline of the original LI-PAD study
Body mass index (BMI) ≥28 and ≤34
Completed the original LI-PAD study
Able and willing to attend follow-up assessments and provide necessary data
Disqualifiers
Known coronary artery disease (clinical symptoms or earlier event)
Inability to understand the language used in the study
Inability to complete follow-up assessments at 18 months
Severe illness or medical condition that, in the investigator's opinion, precludes participation in follow-up assessments
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized physical activity and diet
BehavioralPrecision health
Treatment groups
103 Participants
are divided into 2 treatment groupsGroup A: Individualized Lifestyle ProgramExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Body Weight Change
Change from baseline in body weight measured using calibrated scales and standardized protocols.
Time frame
Baseline, 6 months, 18 monthsSecondary outcomes
1
Change in Body Mass Index (BMI)
Change from baseline in body mass index (BMI) measured using standard protocols.
Time frame
Baseline, 6 months, 18 months.2
Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure measured using standardized sphygmomanometer protocols.
Time frame
Baseline, 6 months, 18 months3
Change in Waist Circumference
Change from baseline in waist circumference (cm) measured using standard protocols.
Time frame
Baseline, 6 months, 18 months4
Change in Hip Circumference
Change from baseline in hip circumference measured using standard protocols.
Time frame
Baseline, 6 months, 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator
Chalmers University of Technology
Collaborator
Source ClinicalTrials.gov