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Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended) (LI-PAD-EXTENDE)

19 maggio 2026 aggiornato da: Vastra Gotaland Region

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:

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

103

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svezia
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Svezia, 416 85
        • Reclutamento
        • Centre for Lifestyle Intervention
        • Contatto:
          • Carina U Persson, study coordinator, research leader, Associate Professor
          • Numero di telefono: +46 706 14 25 60
          • Email: carina.persson@vgregion.se

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Standard di sicurezza
Il gruppo di controllo riceverà (gli verranno offerte) le cure abituali definite come consigli scritti sullo stile di vita basati sulle raccomandazioni generali per la dieta (Nordic Nutrition Recommendations, 2012). Integrare alimentazione e attività fisica. Copenaghen: Consiglio nordico dei ministri, 2014) e PA (Organizzazione mondiale della sanità. Linee guida dell’Organizzazione Mondiale della Sanità sull’attività fisica e il comportamento sedentario, 2020), inclusa una dieta sana e variata, che mira a 300 minuti a settimana di PA aerobica di media intensità e allenamento di forza due volte a settimana.
Sperimentale: Individualized Lifestyle Program
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.
Comportamentale: Attività fisica e dieta individualizzata
Salute di precisione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body Weight Change
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in body weight measured using calibrated scales and standardized protocols.
Baseline, 6 months, 18 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Mass Index (BMI)
Lasso di tempo: Baseline, 6 months, 18 months.
Change from baseline in body mass index (BMI) measured using standard protocols.
Baseline, 6 months, 18 months.
Change in Systolic Blood Pressure
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in systolic blood pressure measured using standardized sphygmomanometer protocols.
Baseline, 6 months, 18 months
Change in Waist Circumference
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in waist circumference (cm) measured using standard protocols.
Baseline, 6 months, 18 months
Change in Hip Circumference
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in hip circumference measured using standard protocols.
Baseline, 6 months, 18 months
Change in Total Cholesterol
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in total cholesterol.
Baseline, 6 months, 18 months
Change in HDL Cholesterol
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in high-density lipoprotein (HDL) cholesterol.
Baseline, 6 months, 18 months
Change in LDL Cholesterol
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in low-density lipoprotein (LDL) cholesterol.
Baseline, 6 months, 18 months
Change in Triglycerides
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in triglycerides
Baseline, 6 months, 18 months
Change in HbA1c
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in glycated hemoglobin (HbA1c)
Baseline, 6 months, 18 months
Change in Aspartate Aminotransferase (ASAT)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in aspartate aminotransferase (ASAT)
Baseline, 6 months, 18 months
Change in Alanine Aminotransferase (ALAT)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in alanine aminotransferase (ALAT).
Baseline, 6 months, 18 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in high-sensitivity C-reactive protein (hs-CRP).
Baseline, 6 months, 18 months
Change in Dietary Biomarkers (Metabolomics)
Lasso di tempo: Baseline, 6 months, 18 months
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.
Baseline, 6 months, 18 months
Change in Cardiorespiratory Fitness (VO₂max)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in cardiorespiratory fitness (VO₂max) (mL/kg/min) assessed using the Ekblom-Bak cycle test.
Baseline, 6 months, 18 months
Change in Muscle Strength (Handgrip Strength)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in muscle strength (kg) assessed by handgrip strength using a Jamar hand dynamometer.
Baseline, 6 months, 18 months
Change in Mean Daily Physical Activity Counts as Assessed by Accelerometry
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in physical activity assessed using accelerometry, summarized as mean daily activity counts at 6 and 18 months.
Baseline, 6 months, 18 months
Change in Self-Reported Physical Activity (Saltin-Grimby Physical Activity Level Scale, SGPALS)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in physical activity assessed using the Saltin-Grimby Physical Activity Level Scale (SGPALS).
Baseline, 6 months, 18 months
Change in Resting Energy Expenditure (REE)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in resting energy expenditure (REE) (kcal/day).
Baseline, 6 months, 18 months
Change in Dietary Intake (MiniMeal-Q questionnaire)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in dietary intake assessed using the MiniMeal-Q questionnaire.
Baseline, 6 months, 18 months
Change in Health-Related Quality of Life (EQ-5D-3L)
Lasso di tempo: Baseline, 6 months, 18 months
Change from baseline in health-related quality of life assessed using the EQ-5D-3L index.
Baseline, 6 months, 18 months
Motivation for Lifestyle Change
Lasso di tempo: 18 months
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).
18 months
Perceived Self-Efficacy
Lasso di tempo: 18 months
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).
18 months
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio, ICER)
Lasso di tempo: 18 months
Incremental cost-effectiveness ratio (ICER) comparing individualized lifestyle intervention to standard advice, expressed as cost per quality-adjusted life year (QALY) gained.
18 months
Motivation for Maintaining Lifestyle Change
Lasso di tempo: 18 months
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).
18 months
Perceived Autonomous Motivation for Weight Management
Lasso di tempo: 18 months
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).
18 months
Perceived Controlled Motivation for Weight Management
Lasso di tempo: 18 months
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).
18 months
Perceived Importance of Individualization in Lifestyle Intervention
Lasso di tempo: 18 months
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).
18 months
Perceived Appropriateness of Study Duration
Lasso di tempo: 18 months
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).
18 months
Perceived Importance of Lifestyle Intervention Components
Lasso di tempo: 18 months
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.
18 months
Perceived Psychological Capabilities for Lifestyle Change
Lasso di tempo: 18 months
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).
18 months
Importance of Behavioral Strategies for Weight Management
Lasso di tempo: 18 months
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).
18 months
Perceived Positive Social Support for Weight Management
Lasso di tempo: 18 months
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).
18 months
Perceived Negative Social Influence on Weight Management
Lasso di tempo: 18 months
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).
18 months
Perceived Environmental Support for Healthy Lifestyle
Lasso di tempo: 18 months
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).
18 months
Perceived Financial Support for Healthy Lifestyle
Lasso di tempo: 18 months
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).
18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Vastra Gotaland Region

Collaboratori

Göteborg University
Chalmers University of Technology

Investigatori

  • Investigatore principale: Mats Börjesson, Professor, University of Gothenburg, Sahlgrenska University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 agosto 2025

Completamento primario (Stimato)

31 maggio 2026

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

16 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 febbraio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LI-PAD EXTENDED
  • 285373 (Altro identificatore: Researchweb, Vastra Gotalandsregionen)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared publicly. Data from LI-PAD-Extended will be used solely for analysis by the study team.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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