Obesity, Overweight, Prediabetic State
Conditions
Keywords
Lifestyle intervention, Physical activity, Diet, Precision health, Overweight, Obesity, Weight loss, Cardiometabolic risk, Health-related quality of life, Behavioral support, Cost-effectiveness
Brief 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. 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.
Interventions
Precision health
Sponsors
Vastra Gotaland Region
Göteborg University
Chalmers University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study. Participants, intervention staff, and study personnel are aware of group assignments due to the nature of the lifestyle intervention. Full blinding is not possible because participants actively engage in individualized physical activity, dietary counseling, and behavioral support. Outcome assessments are performed using objective measurements whenever possible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight Change | Baseline, 6 months, 18 months | Change from baseline in body weight measured using calibrated scales and standardized protocols. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline, 6 months, 18 months. | Change from baseline in body mass index (BMI) measured using standard protocols. |
| Change in Systolic Blood Pressure | Baseline, 6 months, 18 months | Change from baseline in systolic blood pressure measured using standardized sphygmomanometer protocols. |
| Change in Waist Circumference | Baseline, 6 months, 18 months | Change from baseline in waist circumference (cm) measured using standard protocols. |
| Change in Hip Circumference | Baseline, 6 months, 18 months | Change from baseline in hip circumference measured using standard protocols. |
| Change in Total Cholesterol | Baseline, 6 months, 18 months | Change from baseline in total cholesterol. |
| Change in HDL Cholesterol | Baseline, 6 months, 18 months | Change from baseline in high-density lipoprotein (HDL) cholesterol. |
| Change in LDL Cholesterol | Baseline, 6 months, 18 months | Change from baseline in low-density lipoprotein (LDL) cholesterol. |
| Change in Triglycerides | Baseline, 6 months, 18 months | Change from baseline in triglycerides |
| Change in HbA1c | Baseline, 6 months, 18 months | Change from baseline in glycated hemoglobin (HbA1c) |
| Change in Aspartate Aminotransferase (ASAT) | Baseline, 6 months, 18 months | Change from baseline in aspartate aminotransferase (ASAT) |
| Change in Alanine Aminotransferase (ALAT) | Baseline, 6 months, 18 months | Change from baseline in alanine aminotransferase (ALAT). |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline, 6 months, 18 months | Change from baseline in high-sensitivity C-reactive protein (hs-CRP). |
| Change in Dietary Biomarkers (Metabolomics) | 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. |
| Change in Cardiorespiratory Fitness (VO₂max) | Baseline, 6 months, 18 months | Change from baseline in cardiorespiratory fitness (VO₂max) (mL/kg/min) assessed using the Ekblom-Bak cycle test. |
| Change in Muscle Strength (Handgrip Strength) | Baseline, 6 months, 18 months | Change from baseline in muscle strength (kg) assessed by handgrip strength using a Jamar hand dynamometer. |
| Change in Mean Daily Physical Activity Counts as Assessed by Accelerometry | 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. |
| Change in Self-Reported Physical Activity (Saltin-Grimby Physical Activity Level Scale, SGPALS) | Baseline, 6 months, 18 months | Change from baseline in physical activity assessed using the Saltin-Grimby Physical Activity Level Scale (SGPALS). |
| Change in Resting Energy Expenditure (REE) | Baseline, 6 months, 18 months | Change from baseline in resting energy expenditure (REE) (kcal/day). |
| Change in Dietary Intake (MiniMeal-Q questionnaire) | Baseline, 6 months, 18 months | Change from baseline in dietary intake assessed using the MiniMeal-Q questionnaire. |
| Change in Health-Related Quality of Life (EQ-5D-3L) | Baseline, 6 months, 18 months | Change from baseline in health-related quality of life assessed using the EQ-5D-3L index. |
| Motivation for Lifestyle Change | 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). |
| Perceived Self-Efficacy | 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). |
| Cost-Effectiveness (Incremental Cost-Effectiveness Ratio, ICER) | 18 months | Incremental cost-effectiveness ratio (ICER) comparing individualized lifestyle intervention to standard advice, expressed as cost per quality-adjusted life year (QALY) gained. |
| Motivation for Maintaining Lifestyle Change | 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). |
| Perceived Autonomous Motivation for Weight Management | 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). |
| Perceived Controlled Motivation for Weight Management | 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). |
| Perceived Importance of Individualization in Lifestyle Intervention | 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). |
| Perceived Appropriateness of Study Duration | 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). |
| Perceived Importance of Lifestyle Intervention Components | 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. |
| Perceived Psychological Capabilities for Lifestyle Change | 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). |
| Importance of Behavioral Strategies for Weight Management | 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). |
| Perceived Positive Social Support for Weight Management | 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). |
| Perceived Negative Social Influence on Weight Management | 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). |
| Perceived Environmental Support for Healthy Lifestyle | 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). |
| Perceived Financial Support for Healthy Lifestyle | 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). |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORMats Börjesson, Professor
University of Gothenburg, Sahlgrenska University Hospital
Outcome results
None listed