Interdisciplinary Approaches to Managing Excess Weight and Promoting Health in Older Adults: a Multimodal Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Fat-Free Mass
研究概览
简要总结
Aging may be accompanied by changes in body composition, muscle strength, metabolic health, and well-being. In older adults with overweight or obesity, strategies that combine physical exercise, behavioral changes, and nutritional guidance may contribute to better health and the maintenance of healthier habits.
This study aims to investigate the effects of a 16-week intervention combining resistance training, group cognitive behavioral therapy, and nutritional guidance for a higher-protein diet. Changes in body composition, muscle strength and function, vascular and metabolic health, cognitive function, psychological outcomes, quality of life, autonomy, self-care, and motivation for exercise and changes in eating habits will be assessed.
The study will include adults aged 60 years or older who have low levels of physical activity and excess body fat. Participants will be randomly assigned to one of three groups. The first group will receive resistance training only; the second group will receive resistance training plus group cognitive behavioral therapy; and the third group will receive resistance training, group cognitive behavioral therapy, and nutritional guidance for a higher-protein diet. This comparison will help determine the effects of each additional component of the intervention.
Resistance training will be performed three times per week. Group cognitive behavioral therapy sessions will be held weekly and will address strategies to support sustainable behavioral changes, including self-awareness, goal setting, the relationship between thoughts, emotions, and behaviors, problem-solving, and maintenance of behavioral changes. Nutritional guidance will also be provided in weekly group sessions, focusing on the sustainable adoption of a higher-protein diet using commonly consumed foods while considering participants' individual circumstances and autonomy.
Assessments will be conducted before and after the 16-week intervention to evaluate potential changes associated with the interventions. Comparing the three groups will help determine whether adding psychological and nutritional strategies to resistance training provides additional benefits for the physical, metabolic, cognitive, and psychological health of older adults with overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Presence of excess adiposity/overweight or obesity, according to protocol criteria;
- •Medical clearance to perform supervised physical exercises and the tests;
- •No regular participation in structured resistance training over the past 5 months.
排除标准
- •Contraindication to resistance training or physical testing;
- •Unstable or uncontrolled cardiovascular disease;
- •Recent (< 6 months) coronary or cerebrovascular event;
- •Uncontrolled arterial hypertension;
- •Untreated secondary/endocrine causes of obesity;
- •Use of medications that significantly alter body mass or composition;
- •Current use of anti-obesity medication, including GLP-1 agonists;
- •History of bariatric surgery or scheduled procedure;
- •Active weight loss process or weight fluctuation > 5% in the last 6 months.
研究组 & 干预措施
GUNI - Unimodal Intervention
Participants will undergo supervised resistance training (RT) three times per week for 16 weeks. The program will include exercises targeting the upper limbs, lower limbs, and trunk, with progressive intensity throughout the intervention.
干预措施: Resistance Training Program (Behavioral)
GBI - Bimodal Intervention
Participants will undergo the same resistance training program, combined with weekly group cognitive behavioral therapy (CBT) sessions lasting approximately 25-30 minutes. The psychological intervention will focus on supporting behavioral change through self-monitoring, goal setting, cognitive and behavioral strategies, problem-solving, and relapse prevention.
干预措施: Group Cognitive Behavioral Therapy Intervention (Behavioral)
GBI - Bimodal Intervention
Participants will undergo the same resistance training program, combined with weekly group cognitive behavioral therapy (CBT) sessions lasting approximately 25-30 minutes. The psychological intervention will focus on supporting behavioral change through self-monitoring, goal setting, cognitive and behavioral strategies, problem-solving, and relapse prevention.
干预措施: Resistance Training Program (Behavioral)
GINT - Multimodal/Interdisciplinary Intervention
Participants will undergo resistance training + group CBT + group nutritional guidance. In addition to the interventions provided to the GBI group, participants will receive weekly nutritional guidance sessions lasting approximately 25-30 minutes, aimed at the sustainable adoption of a high-protein diet, prioritizing commonly consumed foods and considering participants' socioeconomic and cultural context.
干预措施: Nutritional guidance focused on adopting a high-protein diet. (Behavioral)
GINT - Multimodal/Interdisciplinary Intervention
Participants will undergo resistance training + group CBT + group nutritional guidance. In addition to the interventions provided to the GBI group, participants will receive weekly nutritional guidance sessions lasting approximately 25-30 minutes, aimed at the sustainable adoption of a high-protein diet, prioritizing commonly consumed foods and considering participants' socioeconomic and cultural context.
干预措施: Group Cognitive Behavioral Therapy Intervention (Behavioral)
GINT - Multimodal/Interdisciplinary Intervention
Participants will undergo resistance training + group CBT + group nutritional guidance. In addition to the interventions provided to the GBI group, participants will receive weekly nutritional guidance sessions lasting approximately 25-30 minutes, aimed at the sustainable adoption of a high-protein diet, prioritizing commonly consumed foods and considering participants' socioeconomic and cultural context.
干预措施: Resistance Training Program (Behavioral)
结局指标
主要结局
Change in Fat-Free Mass
时间窗: Baseline and after 16 weeks of intervention.
Change in fat-free mass following the 16-week intervention. Fat-free mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570, InBody Co. Ltd., South Korea) under standardized pre-assessment conditions, including an overnight fast, avoidance of alcohol and caffeine, and abstention from vigorous exercise before testing. Fat-free mass is expressed in kilograms (kg). The primary outcome is the change in fat-free mass from baseline to post-intervention, compared across the three intervention arms.
次要结局
- Change in Body Mass(Baseline and after 16 weeks of intervention.)
- Change in lean mass(Baseline and after 16 weeks of intervention.)
- Change in Appendicular Lean Mass(Baseline and after 16 weeks of intervention.)
- Change in Fat Mass(Baseline and after 16 weeks of intervention.)
- Change in Body Fat Percentage(Baseline and after 16 weeks of intervention.)
- Change in Skeletal Muscle Mass(Baseline and after 16 weeks of intervention.)
- Change in Maximum Isometric Muscle Strength of the Upper Limbs(Baseline and after 16 weeks of intervention.)
- Change in Maximum Isometric Muscle Strength of the Lower Limbs(Baseline and after 16 weeks of intervention.)
- Change in Fasting Plasma Glucose Concentration(Baseline and post-intervention at week 16)
- Change in Medicine Ball Throw Distance(Baseline and after 16 weeks of intervention.)
- Change in Timed Up and Go (TUG) performance(Baseline and after the 16-week intervention)
- Change in lower-limb muscular endurance assessed by the 30-second Chair Stand Test(Baseline and after the 16-week intervention)
- Change in upper-limb muscular endurance assessed by the 30-second Arm Curl Test(Baseline and after the 16-week intervention)
- Change in Fasting Plasma Insulin Concentration(Baseline and post-intervention at week 16.)
- Change in Fasting C-Peptide Concentration(Baseline and post-intervention at week 16.)
- Change in Pulse Wave Velocity(Baseline and after 16 weeks of intervention.)
- Change in Pulse Wave Transit Time(Baseline and after 16 weeks of intervention.)
- Change in Fasting Triglycerides(Baseline and post-intervention at week 16.)
- Change in Fasting Total Cholesterol Concentration(Baseline and post-intervention at week 16.)
- Change in Fasting High-Density Lipoprotein Cholesterol Concentration(Baseline and post-intervention at week 16.)
- Change in Fasting Low-Density Lipoprotein Cholesterol Concentration(Baseline and post-intervention at week 16.)
- Change in Fasting Very-Low-Density Lipoprotein Cholesterol Concentration(Baseline and post-intervention at week 16.)
- Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration(Baseline and post-intervention at week 16)
- Change in Interleukin-6 (IL-6) Concentration(Baseline and post-intervention at week 16.)
- Change in executive cognitive function assessed by the Victoria Stroop Test - completion time(Baseline and after the 16-week intervention)
- Change in executive cognitive function assessed by the Victoria Stroop Test - errors(Baseline and after the 16-week intervention)
- Change in executive cognitive function assessed by the Trail Making Test - completion time(Baseline and after the 16-week intervention)
- Change in executive cognitive function assessed by the Trail Making Test - errors(Baseline and after the 16-week intervention)
- Change in Brain-Derived Neurotrophic Factor (BDNF) Concentration(Baseline and post-intervention at week 16)
- Change in Glucagon-Like Peptide-1 (GLP-1) Concentration(Baseline and post-intervention at week 16)
- Change in Gastrin Concentration(Baseline and post-intervention at week 16.)
- Change in Peptide YY (PYY) Concentration(Baseline and post-intervention at week 16.)
- Change in Leptin Concentration(Baseline and post-intervention at week 16.)
- Change in 15-Item Geriatric Depression Scale Score(Baseline and after 16 weeks of intervention.)
- Change in Beck Depression Inventory-II Total Score(Baseline and after 16 weeks of intervention.)
- Change in Generalized Anxiety Disorder-7 Total Score(Baseline and after 16 weeks of intervention.)
- Change in WHOQOL-OLD Total Quality of Life Score(Baseline and after 16 weeks of intervention.)
- Change in binge eating severity(Baseline and after the 16-week intervention)
- Change in Predominant Readiness-to-Change Stage Assessed by the University of Rhode Island Change Assessment(Baseline and after 16 weeks of intervention.)
- Change in Appraisal of Self-Care Agency Scale Total Score(Baseline and after 16 weeks of intervention.)
- Change in Total Daily Energy Intake(Baseline and after 16 weeks of intervention.)
- Change in Protein Intake(Baseline and post-intervention at week 16.)
- Change in Carbohydrate Intake(Baseline and post-intervention at week 16.)
- Change in Fat Intake(Baseline and post-intervention at week 16.)
- Change in Relative Autonomy Index for Exercise Motivation(Baseline and after 16 weeks of intervention.)
- Change in Basic Psychological Needs in Exercise Scale Overall Score(Baseline and after 16 weeks of intervention.)