Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Individualized physical activity and diet.
- Кому может быть актуально
- Состояния в реестре: Overweight, Obesity, Prediabetic State. Базовые параметры: 45 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
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)
Обзор
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
Подробное описание
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
Вмешательства
- Поведенческое Individualized physical activity and diet
Precision health
Первичные конечные точки
- Body Weight Change [Срок оценки: Baseline, 6 months, 18 months]
Вторичные конечные точки (12)
- Change in Body Mass Index (BMI) [Срок оценки: Baseline, 6 months, 18 months.]
- Change in Systolic Blood Pressure [Срок оценки: Baseline, 6 months, 18 months]
- Change in Waist Circumference [Срок оценки: Baseline, 6 months, 18 months]
- Change in Hip Circumference [Срок оценки: Baseline, 6 months, 18 months]
- Change in Total Cholesterol [Срок оценки: Baseline, 6 months, 18 months]
- Change in HDL Cholesterol [Срок оценки: Baseline, 6 months, 18 months]
- Change in LDL Cholesterol [Срок оценки: Baseline, 6 months, 18 months]
- Change in Triglycerides [Срок оценки: Baseline, 6 months, 18 months]
- Change in HbA1c [Срок оценки: Baseline, 6 months, 18 months]
- Change in Aspartate Aminotransferase (ASAT) [Срок оценки: Baseline, 6 months, 18 months]
- Change in Alanine Aminotransferase (ALAT) [Срок оценки: Baseline, 6 months, 18 months]
- Change in High-Sensitivity C-Reactive Protein (hs-CRP) [Срок оценки: Baseline, 6 months, 18 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Швеция · 1 центр
- Centre for Lifestyle Intervention — Gothenburg
Идентификаторы
NCT: NCT07605169 · LI-PAD EXTENDED · 285373