OverweightLI-PAD-EXTENDENCT07605169
Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)
A study testing Individualized physical activity and diet in people with Overweight and Obesity, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Overweight, Obesity, Prediabetic State
- What is being tested?
- Individualized physical activity and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- 11 Aug 2025to 31 Dec 2027
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able and willing to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Lifestyle Intervention
Gothenburg, Västra Götaland County, 416 85
About this study
Official title: Long-term Follow-up of Individualized Lifestyle Intervention Focused on Physical Activity and Diet: Effects on Weight Loss, Dietary Habits, Cardiovascular Health, Motivation, Health-related Quality of Life, and Health Economics (LI-PAD-Extended)
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:
Read more
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
Read the detailed description
Background Overweight and obese adults, especially those with type 2 diabetes, have increased risk of cardiovascular disease (CVD). Lifestyle interventions with physical activity (PA) and diet improve CVD risk factors, but long-term behavior change is challenging. Individualized approaches are recommended, yet rarely implemented for both PA and diet in clinical practice.
Objectives
The study evaluates whether an individualized precision health intervention:
Produces greater weight loss at 6 months (short-term) and 18 months (long-term)
Improves cardiovascular risk factors, metabolic markers, diet, PA behaviors, fitness, and psychosocial outcomes
Is feasible and cost-effective compared to standard lifestyle advice
Study Design
Randomized controlled trial with two arms:
Intervention group: Individualized precision health program
Control group: Standard lifestyle advice
Total participants: 120 (60 per group), aged 45-65 years, BMI 28-34
Exclusion: known coronary artery disease, inability to participate in lifestyle interventions, or language barriers
Intervention (LI-PAD Precision Health):
Step 1: Individual Adaptation
Adjust recommendations for medical conditions, comorbidities, medications, psychosocial factors, preferences, readiness to change, and barriers/facilitators
Step 2: Individualized Advice
PA prescription based on accelerometry, VO₂max, and muscle strength
Dietary guidance based on food intake diaries and measured resting energy expenditure (REE)
Step 3: Support for Goal Achievement
Education and skill training
Behavioral support: health promoters, group sessions, face-to-face and online coaching, apps for diet and PA, nudging
Control Group:
Standard lifestyle advice: healthy diet, ≥300 min/week moderate-intensity aerobic PA, 2 sessions/week strength training
Outcome Measures:
Primary Outcome:
Change in body weight from baseline to 6 months and 18 months
Secondary Outcomes:
BMI, waist and hip circumference
Blood pressure
Blood markers: cardiometabolic (lipids, HbA1c, cholesterol, HDL, LDL; ASAT, ALAT, ALP, GGT, hs-CRP) and dietary intake biomarkers
Cardiorespiratory fitness and muscle strength
Behavioral measures: PA (accelerometry, SGPALS), diet (MiniMeal-Q, REE)
Psychosocial outcomes: health-related quality of life (EQ5D-3L, RAND-36), motivation, self-efficacy
Cost-effectiveness analysis based on BMI and secondary outcomes
Additional Outcomes (Intervention Group):
Feasibility: attendance, compliance, participant evaluation
Barriers and facilitators to behavioral change
GPS tracking of PA and dietary behavior
Assessments:
Baseline, 6-month, and 18-month follow-ups
Anthropometry, REE, blood pressure, blood markers, fitness tests, accelerometry, questionnaires, and dietary logs
Statistical Analysis:
Multilevel mixed models for repeated measures
Linear and logistic regression for continuous and categorical variables
Structural equation modeling and partial least squares regression to explore relationships between intervention components and outcomes
Collaborators:
Sahlgrenska University Hospital/Östra: health promoters, physiotherapists, biomedical analysts
University of Gothenburg: Food and Nutrition, Sport Science, metabolomics, health economics
National and international collaborators with expertise in PA, diet, and cardiovascular health
Summary:
LI-PAD-Extended is an 18-month follow-up evaluating individualized precision health interventions. The study combines objective PA and dietary assessments with behavioral support and cost-effectiveness evaluation. This long-term follow-up allows assessment of sustained effects of precision lifestyle interventions on weight, cardiovascular risk, fitness, psychosocial outcomes, and economic efficiency.
- Conditions
- Overweight, Obesity, Prediabetic State
- Being tested
- Individualized physical activity and diet
- Keywords
- Lifestyle intervention, Physical activity, Diet, Precision health, Overweight, Obesity, Weight loss, Cardiometabolic risk, Health-related quality of life, Behavioral support, Cost-effectiveness
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized physical activity and dietBehavioural
Precision health
| Study group | Role | What they receive |
|---|---|---|
| Individualized Lifestyle Program | Experimental | The intervention group will receive (offered) an optimal prescription of physical activity and diet based on medical (comorbidities, risk profile, medications, symptoms) and psycho-social (preferences for physical activities and diet, barriers-facilitators, social support, readiness to change, accelerometry and predicted VO2-max data (Ekblom Bak ergometer test), resting energy expenditure and knowledge and skills (lifestyle education school for achieving knowledge and skills in handling change in diet and physical activity in daily life) and support (health promotors, behavioral change app, food diary app, face-to-face, phone/online coaching, physical activity (aerobic training, strength training) in group and nudging. Receives: Behavioral: Individualized physical activity and diet |
| Standard of care | No intervention | The control group will receive (be offered) usual care defined as written lifestyle advices based on the general recommendations for diet (Nordic Nutrition Recommendations, 2012. Integrating nutrition and physical activity. Copenhagen: Nordic Council of Ministers, 2014) and PA (World Health Organization. World Health Organization guidelines on physical activity and sedentary behavior, 2020), including a healthy and varied diet, aiming at 300 mins/week of medium intensity aerobic PA and strength training two times per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change
Change from baseline in body weight measured using calibrated scales and standardized protocols.
Measured: Baseline, 6 months, 18 months
Secondary outcomes (35)
Change in Body Mass Index (BMI)
Change from baseline in body mass index (BMI) measured using standard protocols.
Measured: Baseline, 6 months, 18 months.
Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure measured using standardized sphygmomanometer protocols.
Measured: Baseline, 6 months, 18 months
Change in Waist Circumference
Change from baseline in waist circumference (cm) measured using standard protocols.
Measured: Baseline, 6 months, 18 months
Change in Hip Circumference
Change from baseline in hip circumference measured using standard protocols.
Measured: Baseline, 6 months, 18 months
Change in Total Cholesterol
Change from baseline in total cholesterol.
Measured: Baseline, 6 months, 18 months
Change in HDL Cholesterol
Change from baseline in high-density lipoprotein (HDL) cholesterol.
Measured: Baseline, 6 months, 18 months
Change in LDL Cholesterol
Change from baseline in low-density lipoprotein (LDL) cholesterol.
Measured: Baseline, 6 months, 18 months
Change in Triglycerides
Change from baseline in triglycerides
Measured: Baseline, 6 months, 18 months
Change in HbA1c
Change from baseline in glycated hemoglobin (HbA1c)
Measured: Baseline, 6 months, 18 months
Change in Aspartate Aminotransferase (ASAT)
Change from baseline in aspartate aminotransferase (ASAT)
Measured: Baseline, 6 months, 18 months
Change in Alanine Aminotransferase (ALAT)
Change from baseline in alanine aminotransferase (ALAT).
Measured: Baseline, 6 months, 18 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Change from baseline in high-sensitivity C-reactive protein (hs-CRP).
Measured: Baseline, 6 months, 18 months
Change in Dietary Biomarkers (Metabolomics)
Change from baseline in dietary biomarkers assessed using metabolomics. Biomarkers reflect intake of selected food groups (e.g., whole grains, dairy products, legumes, and sugars) and are quantified using validated analytical methods and expressed as relative concentrations or standardized scores.
Measured: Baseline, 6 months, 18 months
Change in Cardiorespiratory Fitness (VO₂max)
Change from baseline in cardiorespiratory fitness (VO₂max) (mL/kg/min) assessed using the Ekblom-Bak cycle test.
Measured: Baseline, 6 months, 18 months
Change in Muscle Strength (Handgrip Strength)
Change from baseline in muscle strength (kg) assessed by handgrip strength using a Jamar hand dynamometer.
Measured: Baseline, 6 months, 18 months
Change in Mean Daily Physical Activity Counts as Assessed by Accelerometry
Change from baseline in physical activity assessed using accelerometry, summarized as mean daily activity counts at 6 and 18 months.
Measured: Baseline, 6 months, 18 months
Change in Self-Reported Physical Activity (Saltin-Grimby Physical Activity Level Scale, SGPALS)
Change from baseline in physical activity assessed using the Saltin-Grimby Physical Activity Level Scale (SGPALS).
Measured: Baseline, 6 months, 18 months
Change in Resting Energy Expenditure (REE)
Change from baseline in resting energy expenditure (REE) (kcal/day).
Measured: Baseline, 6 months, 18 months
Change in Dietary Intake (MiniMeal-Q questionnaire)
Change from baseline in dietary intake assessed using the MiniMeal-Q questionnaire.
Measured: Baseline, 6 months, 18 months
Change in Health-Related Quality of Life (EQ-5D-3L)
Change from baseline in health-related quality of life assessed using the EQ-5D-3L index.
Measured: Baseline, 6 months, 18 months
Motivation for Lifestyle Change
Motivation assessed at 18 months using a standardized questionnaire. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Self-Efficacy
Self-efficacy assessed at 18 months using a standardized questionnaire. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio, ICER)
Incremental cost-effectiveness ratio (ICER) comparing individualized lifestyle intervention to standard advice, expressed as cost per quality-adjusted life year (QALY) gained.
Measured: 18 months
Motivation for Maintaining Lifestyle Change
Motivation for maintaining lifestyle change, assessed at 18 months using a single-item question rated on a scale from 0 (not at all important) to 10 (extremely important). Higher scores indicate greater motivation. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Autonomous Motivation for Weight Management
Autonomous motivation for weight management, assessed at 18 months using a study-specific multi-item questionnaire. Items reflecting intrinsic motivation are rated on a 5-point Likert scale (1 = not at all true to 5 = completely true) and aggregated into a mean score. Higher scores indicate greater autonomous motivation. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Controlled Motivation for Weight Management
Controlled motivation for weight management, assessed at 18 months using a study-specific multi-item questionnaire. Items reflecting external and introjected regulation are rated on a 5-point Likert scale (1 = not at all true to 5 = completely true) and aggregated into a mean score. Higher scores indicate greater controlled motivation. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Importance of Individualization in Lifestyle Intervention
Participant-reported perceived importance of individualized components of the lifestyle intervention for maintaining weight stability or weight loss, assessed at 18 months using a study-specific single-item question rated on a 5-point Likert scale (1 = not at all to 5 = completely). Higher scores indicate greater perceived importance. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Appropriateness of Study Duration
Participant-reported perception of study duration in relation to achieving sustainable lifestyle change, assessed at 18 months using a single-item categorical question with response options: "too short," "somewhat short," "appropriate," "somewhat long," and "too long." The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Importance of Lifestyle Intervention Components
Participant-reported perceived importance of different components of the lifestyle intervention (e.g., counseling sessions, mobile application, gym access, supervised exercise, and educational sessions) for maintaining weight stability or weight loss. Each component is rated on a 5-point Likert scale (1 = not at all to 5 = completely). Items are aggregated into a mean score based on available responses. Higher scores indicate greater perceived importance of the intervention components. Participants who did not engage in a specific component are excluded from that item in the score calculation.
Measured: 18 months
Perceived Psychological Capabilities for Lifestyle Change
Psychological capabilities for lifestyle change, assessed at 18 months using a study-specific multi-item questionnaire. Items related to self-efficacy, stress management, behavioral awareness, and ability to initiate and maintain behavior change are rated on a 5-point Likert scale (1 = not at all to 5 = completely) and aggregated into a mean score. Higher scores indicate greater perceived capability for lifestyle change. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Importance of Behavioral Strategies for Weight Management
Participant-reported importance of behavioral strategies for weight management, assessed at 18 months using a study-specific multi-item questionnaire. Items related to dietary awareness, meal planning, portion control, weight monitoring, and self-monitoring behaviors are rated on a 5-point Likert scale (1 = not at all important to 5 = very important) and aggregated into a mean score. Higher scores indicate greater perceived importance of behavioral strategies. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Positive Social Support for Weight Management
Perceived positive social support for weight management, assessed at 18 months using a study-specific multi-item questionnaire. Items related to emotional and practical support from close contacts and external support services are rated on a 5-point Likert scale (1 = not at all to 5 = completely) and aggregated into a mean score. Higher scores indicate greater perceived positive social support. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Negative Social Influence on Weight Management
Perceived negative social influence on weight management, assessed at 18 months using a study-specific multi-item questionnaire. Items related to negative comments and social norms are rated on a 5-point Likert scale (1 = not at all to 5 = completely) and aggregated into a mean score. Higher scores indicate greater negative social influence. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Environmental Support for Healthy Lifestyle
Perceived environmental support for maintaining a healthy lifestyle, assessed at 18 months using a study-specific multi-item questionnaire. Items related to home environment, workplace environment, and commuting environment in relation to physical activity and healthy eating are rated on a 5-point Likert scale (1 = not at all to 5 = completely) and aggregated into a mean score. Higher scores indicate greater perceived environmental support for healthy lifestyle behaviors. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Perceived Financial Support for Healthy Lifestyle
Perceived financial support for maintaining a healthy lifestyle, assessed at 18 months using a study-specific multi-item questionnaire. Items related to financial ability to engage in physical activity and maintain a healthy diet are rated on a 5-point Likert scale (1 = not at all to 5 = completely) and aggregated into a mean score. Higher scores indicate greater perceived financial support for healthy lifestyle behaviors. The assessment reflects the preceding 12 months (i.e., the period between the 6-month and 18-month follow-up).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start11 Aug 2025
- Primary completion25 May 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Model description
- Participants are randomly assigned to either the individualized lifestyle intervention group or the control group receiving standard lifestyle advice. Both groups are followed simultaneously over 18 months to compare outcomes on weight, cardiometabolic risk factors, physical activity, diet, fitness, quality of life, and cost-effectiveness.
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University, Chalmers University of Technology
- Responsible party
- Sponsor
- Investigators
- Mats Börjesson, Professor, Principal investigator, University of Gothenburg, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605169
- Sponsor's protocol ID
- LI-PAD EXTENDED
- Other IDs
- 285373
- Acronym
- LI-PAD-EXTENDE
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Data from LI-PAD-Extended will be used solely for analysis by the study team.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Individualized Lifestyle Intervention Focused on Physical Activity and Diet: Effects on Weight Loss, Dietary Habits, Cardiovascular Health, Motivation, Health-related Quality of Life, and Health Economics (LI-PAD-Extended)
- ClinicalTrials.gov ID
- NCT07605169
- Acronym / sponsor ID
- LI-PAD-EXTENDE / LI-PAD EXTENDED
- Conditions
- Overweight, Obesity, Prediabetic State
- Keywords
- Lifestyle intervention, Physical activity, Diet, Precision health, Overweight, Obesity, Weight loss, Cardiometabolic risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University, Chalmers University of Technology
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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.
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
Detailed description
Background Overweight and obese adults, especially those with type 2 diabetes, have increased risk of cardiovascular disease (CVD). Lifestyle interventions with physical activity (PA) and diet improve CVD risk factors, but long-term behavior change is challenging. Individualized approaches are recommended, yet rarely implemented for both PA and diet in clinical practice.
Objectives
The study evaluates whether an individualized precision health intervention:
Produces greater weight loss at 6 months (short-term) and 18 months (long-term)
Improves cardiovascular risk factors, metabolic markers, diet, PA behaviors, fitness, and psychosocial outcomes
Is feasible and cost-effective compared to standard lifestyle advice
Study Design
Randomized controlled trial with two arms:
Intervention group: Individualized precision health program
Control group: Standard lifestyle advice
Total participants: 120 (60 per group), aged 45-65 years, BMI 28-34
Exclusion: known coronary artery disease, inability to participate in lifestyle interventions, or language barriers
Intervention (LI-PAD Precision Health):
Step 1: Individual Adaptation
Adjust recommendations for medical conditions, comorbidities, medications, psychosocial factors, preferences, readiness to change, and barriers/facilitators
Step 2: Individualized Advice
PA prescription based on accelerometry, VO₂max, and muscle strength
Dietary guidance based on food intake diaries and measured resting energy expenditure (REE)
Step 3: Support for Goal Achievement
Education and skill training
Behavioral support: health promoters, group sessions, face-to-face and online coaching, apps for diet and PA, nudging
Control Group:
Standard lifestyle advice: healthy diet, ≥300 min/week moderate-intensity aerobic PA, 2 sessions/week strength training
Outcome Measures:
Primary Outcome:
Change in body weight from baseline to 6 months and 18 months
Secondary Outcomes:
BMI, waist and hip circumference
Blood pressure
Blood markers: cardiometabolic (lipids, HbA1c, cholesterol, HDL, LDL; ASAT, ALAT, ALP, GGT, hs-CRP) and dietary intake biomarkers
Cardiorespiratory fitness and muscle strength
Behavioral measures: PA (accelerometry, SGPALS), diet (MiniMeal-Q, REE)
Psychosocial outcomes: health-related quality of life (EQ5D-3L, RAND-36), motivation, self-efficacy
Cost-effectiveness analysis based on BMI and secondary outcomes
Additional Outcomes (Intervention Group):
Feasibility: attendance, compliance, participant evaluation
Barriers and facilitators to behavioral change
GPS tracking of PA and dietary behavior
Assessments:
Baseline, 6-month, and 18-month follow-ups
Anthropometry, REE, blood pressure, blood markers, fitness tests, accelerometry, questionnaires, and dietary logs
Statistical Analysis:
Multilevel mixed models for repeated measures
Linear and logistic regression for continuous and categorical variables
Structural equation modeling and partial least squares regression to explore relationships between intervention components and outcomes
Collaborators:
Sahlgrenska University Hospital/Östra: health promoters, physiotherapists, biomedical analysts
University of Gothenburg: Food and Nutrition, Sport Science, metabolomics, health economics
National and international collaborators with expertise in PA, diet, and cardiovascular health
Summary:
LI-PAD-Extended is an 18-month follow-up evaluating individualized precision health interventions. The study combines objective PA and dietary assessments with behavioral support and cost-effectiveness evaluation. This long-term follow-up allows assessment of sustained effects of precision lifestyle interventions on weight, cardiovascular risk, fitness, psychosocial outcomes, and economic efficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the individualized lifestyle intervention group or the control group receiving standard lifestyle advice. Both groups are followed simultaneously over 18 months to compare outcomes on weight, cardiometabolic risk factors, physical activity, diet, fitness, quality of life, and cost-effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Individualized Lifestyle Program | Experimental | Behavioral: Individualized physical activity and dietThe intervention group will receive (offered) an optimal prescription of physical activity and diet based on medical (comorbidities, risk profile, medications, symptoms) and psycho-social (preferences for physical activities and diet, barriers-facilitators, social support, readiness to change, accelerometry and predicted VO2-max data (Ekblom Bak ergometer test), resting energy expenditure and knowledge and skills (lifestyle education school for achieving knowledge and skills in handling change in diet and physical activity in daily life) and support (health promotors, behavioral change app, food diary app, face-to-face, phone/online coaching, physical activity (aerobic training, strength training) in group and nudging. |
| Standard of care | No intervention | –The control group will receive (be offered) usual care defined as written lifestyle advices based on the general recommendations for diet (Nordic Nutrition Recommendations, 2012. Integrating nutrition and physical activity. Copenhagen: Nordic Council of Ministers, 2014) and PA (World Health Organization. World Health Organization guidelines on physical activity and sedentary behavior, 2020), including a healthy and varied diet, aiming at 300 mins/week of medium intensity aerobic PA and strength training two times per week. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Individualized physical activity and dietPrecision health | Behavioural | Individualized Lifestyle Program |
Primary outcome
Body Weight Change
Time frame: Baseline, 6 months, 18 months
Change from baseline in body weight measured using calibrated scales and standardized protocols.
35 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, 6 months, 18 months.
Change in Systolic Blood Pressure
Time frame: Baseline, 6 months, 18 months
Change in Waist Circumference
Time frame: Baseline, 6 months, 18 months
Change in Hip Circumference
Time frame: Baseline, 6 months, 18 months
Change in Total Cholesterol
Time frame: Baseline, 6 months, 18 months
Change in HDL Cholesterol
Time frame: Baseline, 6 months, 18 months
Change in LDL Cholesterol
Time frame: Baseline, 6 months, 18 months
Change in Triglycerides
Time frame: Baseline, 6 months, 18 months
Change in HbA1c
Time frame: Baseline, 6 months, 18 months
Change in Aspartate Aminotransferase (ASAT)
Time frame: Baseline, 6 months, 18 months
Change in Alanine Aminotransferase (ALAT)
Time frame: Baseline, 6 months, 18 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, 6 months, 18 months
Change in Dietary Biomarkers (Metabolomics)
Time frame: Baseline, 6 months, 18 months
Change in Cardiorespiratory Fitness (VO₂max)
Time frame: Baseline, 6 months, 18 months
Change in Muscle Strength (Handgrip Strength)
Time frame: Baseline, 6 months, 18 months
Change in Mean Daily Physical Activity Counts as Assessed by Accelerometry
Time frame: Baseline, 6 months, 18 months
Change in Self-Reported Physical Activity (Saltin-Grimby Physical Activity Level Scale, SGPALS)
Time frame: Baseline, 6 months, 18 months
Change in Resting Energy Expenditure (REE)
Time frame: Baseline, 6 months, 18 months
Change in Dietary Intake (MiniMeal-Q questionnaire)
Time frame: Baseline, 6 months, 18 months
Change in Health-Related Quality of Life (EQ-5D-3L)
Time frame: Baseline, 6 months, 18 months
Motivation for Lifestyle Change
Time frame: 18 months
Perceived Self-Efficacy
Time frame: 18 months
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio, ICER)
Time frame: 18 months
Motivation for Maintaining Lifestyle Change
Time frame: 18 months
Perceived Autonomous Motivation for Weight Management
Time frame: 18 months
Perceived Controlled Motivation for Weight Management
Time frame: 18 months
Perceived Importance of Individualization in Lifestyle Intervention
Time frame: 18 months
Perceived Appropriateness of Study Duration
Time frame: 18 months
Perceived Importance of Lifestyle Intervention Components
Time frame: 18 months
Perceived Psychological Capabilities for Lifestyle Change
Time frame: 18 months
Importance of Behavioral Strategies for Weight Management
Time frame: 18 months
Perceived Positive Social Support for Weight Management
Time frame: 18 months
Perceived Negative Social Influence on Weight Management
Time frame: 18 months
Perceived Environmental Support for Healthy Lifestyle
Time frame: 18 months
Perceived Financial Support for Healthy Lifestyle
Time frame: 18 months
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 28 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Data from LI-PAD-Extended will be used solely for analysis by the study team.
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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. This study is not recruiting at the moment.
Mats Börjesson, Professor principal investigator
University of Gothenburg, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized physical activity and diet in people with Overweight and Obesity, run by Vastra Gotaland Region 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Change (time frame: Baseline, 6 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.