Obesity & Overweight
Conditions
Keywords
obesity, aging, resistance training, high-protein diet, cognitive-behavioral therapy, self-determination
Brief summary
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.
Interventions
BEHAVIORALNutritional guidance focused on adopting a high-protein diet.
The nutritional guidance will be delivered in a group setting by nutritionist(s), with 16 weekly sessions lasting 25-30 minutes over 16 weeks. The intervention will focus on the sustainable adoption of a high-protein diet based on commonly consumed foods, without providing protein supplements and considering participants' socioeconomic and cultural contexts. The protein target will be 1.2-1.6 g/kg/day, calculated using adjusted body weight and distributed evenly across main meals. Accessible, high-quality protein sources will be prioritized, supported by practical nutrition education strategies such as meal planning, portion guides, and food substitution lists. Adherence will be monitored using 3-day food diaries completed every three weeks. The program will be organized into four progressive modules, ranging from nutrition fundamentals in aging to the consolidation and maintenance of dietary changes.
BEHAVIORALGroup Cognitive Behavioral Therapy Intervention
The Cognitive Behavioral Therapy (CBT) intervention will be delivered weekly in 25-30-minute group sessions, conducted by a trained psychologist for the GBI and GINT groups. The program will focus on promoting sustainable changes in thoughts, emotions, and behaviors related to excess weight. It will be structured into four progressive modules: Foundations and Self-Awareness; Cognitive and Behavioral Skills; Biopsychosocial Integration; and Consolidation and Maintenance. Strategies will include psychoeducation, self-monitoring, goal setting, stimulus control, cognitive restructuring, problem-solving, and relapse prevention. The intervention will specifically address emotional eating, eating disinhibition, and self-efficacy and will be integrated with nutritional guidance and resistance training. Homework assignments and adherence monitoring will be used throughout the intervention.
BEHAVIORALResistance Training Program
The resistance training (RT) program will be conducted over 16 weeks, with three sessions per week on non-consecutive days, each lasting approximately 40 minutes and supervised by qualified Physical Education and Physiotherapy professionals. The protocol will include exercises targeting the upper limbs, lower limbs, and trunk, performed in two 1-minute sets, with 45-second rest intervals. Training intensity will be monitored using the OMNI Rating of Perceived Exertion Scale (OMNI-RPE) and progressively adjusted across six phases, starting from very light to light effort, progressing to hard to very hard effort, and ending with a recovery week. Before the intervention, participants will complete familiarization sessions covering the exercises, proper technique, and the perceived exertion scale to ensure safety and reliable monitoring of training intensity.
Sponsors
Universidade Cesumar (UNICESUMAR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
A randomized controlled trial with a parallel-group, mixed-methods design, lasting 16 weeks and comprising three intervention arms: resistance training (GUNI); resistance training + group cognitive behavioral therapy (GBI); and resistance training + group cognitive behavioral therapy + nutritional guidance for a high-protein diet (GINT). The additive design will allow the incremental contribution of each intervention component to be evaluated.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat-Free Mass | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass | Baseline and after 16 weeks of intervention. | Change in body mass from baseline to post-intervention. Body mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in lean mass | Baseline and after 16 weeks of intervention. | Change in lean mass from baseline to post-intervention. Lean mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Appendicular Lean Mass | Baseline and after 16 weeks of intervention. | Change in appendicular lean mass from baseline to post-intervention. Appendicular lean mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fat Mass | Baseline and after 16 weeks of intervention. | Change in fat mass from baseline to post-intervention. Fat mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Body Fat Percentage | Baseline and after 16 weeks of intervention. | Change in body fat percentage from baseline to post-intervention. Body fat percentage is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported as a percentage (%). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Skeletal Muscle Mass | Baseline and after 16 weeks of intervention. | Change in skeletal muscle mass from baseline to post-intervention. Skeletal muscle mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value. |
| 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 upper limbs from baseline to post-intervention. Maximum isometric muscle strength is assessed using the strength-testing procedure specified in the study protocol and reported in Newtons (N). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Maximum Isometric Muscle Strength of the Lower Limbs | Baseline and after 16 weeks of intervention. | Change in maximum isometric muscle strength of the lower limbs from baseline to post-intervention. Maximum isometric muscle strength is assessed using the strength-testing procedure specified in the study protocol and reported in Newtons (N). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Medicine Ball Throw Distance | Baseline and after 16 weeks of intervention. | Change in upper-limb rapid muscle performance from baseline to post-intervention is assessed using the Medicine Ball Throw Test. Participants perform a seated horizontal throw of a 2-kg medicine ball from chest level using a maximal explosive effort. The distance from the anterior edge of the chair to the point of first contact of the ball with the floor is measured using a metric tape. Three trials are performed, with a 60-second rest interval between trials, and the greatest distance achieved is used for analysis. Higher values indicate better upper-limb rapid muscle performance. Change in the greatest throwing distance is calculated as the post-intervention value minus the baseline value. |
| Change in Timed Up and Go (TUG) performance | Baseline and after the 16-week intervention | Change in functional mobility from baseline to post-intervention will be assessed using the Timed Up and Go (TUG) test. Participants will be instructed to stand up from a chair, walk the distance specified in the study protocol, turn around, return to the chair, and sit down. Performance will be recorded as the time required to complete the test, in seconds. |
| Change in lower-limb muscular endurance assessed by the 30-second Chair Stand Test | Baseline and after the 16-week intervention | Lower-limb muscular endurance will be assessed using the 30-second Chair Stand Test. Participants will perform as many complete sit-to-stand repetitions as possible within 30 seconds. The total number of correctly completed repetitions will be recorded, with higher values indicating better muscular endurance. |
| Change in upper-limb muscular endurance assessed by the 30-second Arm Curl Test | Baseline and after the 16-week intervention | Upper-limb muscular endurance will be assessed using the 30-second Arm Curl Test. Participants will perform as many complete elbow flexion and extension repetitions as possible within 30 seconds using a standardized dumbbell (2 kg for women and 4 kg for men). The total number of correctly completed repetitions will be recorded, with higher values indicating better muscular endurance. |
| Change in Fasting Plasma Glucose Concentration | Baseline and post-intervention at week 16 | Change in fasting plasma glucose concentration from baseline to post-intervention. Fasting plasma glucose is measured using an enzymatic colorimetric method and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting Plasma Insulin Concentration | Baseline and post-intervention at week 16. | Change in fasting plasma insulin concentration from baseline to post-intervention. Fasting plasma insulin is measured by radioimmunoassay and reported in microunits per milliliter (µU/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting C-Peptide Concentration | Baseline and post-intervention at week 16. | Change in fasting C-peptide concentration from baseline to post-intervention. Fasting C-peptide is measured in fasting blood samples and reported in nanograms per milliliter (ng/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Pulse Wave Velocity | Baseline and after 16 weeks of intervention. | Change in pulse wave velocity (PWV) from baseline to post-intervention. PWV is assessed as a measure of arterial stiffness and reported in meters per second (m/s). The outcome is calculated as the post-intervention value minus the baseline value. Lower PWV values indicate lower arterial stiffness. |
| Change in Pulse Wave Transit Time | Baseline and after 16 weeks of intervention. | Change in pulse wave transit time (PWTT) from baseline to post-intervention. PWTT is assessed as the time required for the arterial pulse wave to travel between the predefined measurement sites and reported in milliseconds (ms). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting Triglycerides | Baseline and post-intervention at week 16. | Change in fasting triglyceride concentration from baseline to post-intervention. Fasting triglycerides are measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting Total Cholesterol Concentration | Baseline and post-intervention at week 16. | Change in fasting total cholesterol concentration from baseline to post-intervention. Total cholesterol is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting High-Density Lipoprotein Cholesterol Concentration | Baseline and post-intervention at week 16. | Change in fasting high-density lipoprotein cholesterol (HDL-C) concentration from baseline to post-intervention. HDL-C is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting Low-Density Lipoprotein Cholesterol Concentration | Baseline and post-intervention at week 16. | Change in fasting low-density lipoprotein cholesterol (LDL-C) concentration from baseline to post-intervention. LDL-C is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fasting Very-Low-Density Lipoprotein Cholesterol Concentration | Baseline and post-intervention at week 16. | Change in fasting very-low-density lipoprotein cholesterol (VLDL-C) concentration from baseline to post-intervention. VLDL-C is reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration | Baseline and post-intervention at week 16 | Change in circulating tumor necrosis factor alpha (TNF-α) concentration from baseline to post-intervention. TNF-α is measured in blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Interleukin-6 (IL-6) Concentration | Baseline and post-intervention at week 16. | Change in circulating interleukin-6 (IL-6) concentration from baseline to post-intervention. IL-6 is measured in blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in executive cognitive function assessed by the Victoria Stroop Test - completion time | Baseline and after the 16-week intervention | Executive cognitive function will be assessed using the Victoria Stroop Test, comprising three conditions: color, neutral words, and incongruent color words. Performance will be assessed by the time required to complete each condition. |
| Change in executive cognitive function assessed by the Victoria Stroop Test - errors | Baseline and after the 16-week intervention | Executive cognitive function will be assessed using the Victoria Stroop Test. The number of errors made during the test will be recorded, with fewer errors indicating better performance. |
| Change in executive cognitive function assessed by the Trail Making Test - completion time | Baseline and after the 16-week intervention | Cognitive function will be assessed using the Trail Making Test (TMT), including Parts A and B. Performance will be assessed by the time required to complete each part. |
| Change in executive cognitive function assessed by the Trail Making Test - errors | Baseline and after the 16-week intervention | Cognitive function will be assessed using the Trail Making Test (TMT), including Parts A and B. The number of errors made during each part will be recorded, with fewer errors indicating better performance. |
| Change in Brain-Derived Neurotrophic Factor (BDNF) Concentration | Baseline and post-intervention at week 16 | Change in fasting plasma brain-derived neurotrophic factor (BDNF) concentration from baseline to post-intervention. BDNF is measured in fasting blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Glucagon-Like Peptide-1 (GLP-1) Concentration | Baseline and post-intervention at week 16 | Change in fasting plasma glucagon-like peptide-1 (GLP-1) concentration from baseline to post-intervention. GLP-1 is measured in fasting blood samples and reported in picomoles per liter (pmol/L). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Gastrin Concentration | Baseline and post-intervention at week 16. | Change in fasting plasma gastrin concentration from baseline to post-intervention. Gastrin is measured in fasting blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Peptide YY (PYY) Concentration | Baseline and post-intervention at week 16. | Change in fasting plasma peptide YY (PYY) concentration from baseline to post-intervention. PYY is measured in fasting blood samples and reported in nanograms per deciliter (ng/dL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Leptin Concentration | Baseline and post-intervention at week 16. | Change in fasting plasma leptin concentration from baseline to post-intervention. Leptin is measured in fasting blood samples and reported in nanograms per milliliter (ng/mL). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in 15-Item Geriatric Depression Scale Score | Baseline and after 16 weeks of intervention. | Change in depressive symptoms from baseline to post-intervention is assessed using the 15-item Geriatric Depression Scale (GDS-15). The GDS-15 consists of 15 items, with a total score ranging from 0 to 15 points. Higher scores indicate greater depressive symptom severity. Change in the GDS-15 total score is calculated as the post-intervention score minus the baseline score. |
| Change in Beck Depression Inventory-II Total Score | Baseline and after 16 weeks of intervention. | Change in depressive symptom severity from baseline to post-intervention is assessed using the Beck Depression Inventory Second Edition (BDI-II). The BDI-II is a 21-item self-report instrument that assesses depressive symptoms experienced during the previous two weeks. Each item is scored from 0 to 3 points, resulting in a total score ranging from 0 to 63 points. Higher scores indicate greater severity of depressive symptoms. Scores are interpreted as follows: 0-13, minimal; 14-19, mild; 20-28, moderate; and 29-63, severe depressive symptom severity. Change in the BDI-II total score is calculated as the post-intervention score minus the baseline score. |
| Change in Generalized Anxiety Disorder-7 Total Score | Baseline and after 16 weeks of intervention. | Change in anxiety symptom severity from baseline to post-intervention is assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). The GAD-7 consists of 7 items, each scored from 0 to 3 points, resulting in a total score ranging from 0 to 21 points. Higher scores indicate greater severity of anxiety symptoms. Change in the GAD-7 total score is calculated as the post-intervention score minus the baseline score. |
| Change in WHOQOL-OLD Total Quality of Life Score | Baseline and after 16 weeks of intervention. | Change in quality of life from baseline to post-intervention is assessed using the World Health Organization Quality of Life-OLD (WHOQOL-OLD) instrument. The WHOQOL-OLD consists of 24 items covering six facets: Sensory Abilities, Autonomy, Past, Present and Future Activities, Social Participation, Death and Dying, and Intimacy. A total quality-of-life score is calculated according to the WHOQOL-OLD scoring procedure and transformed to a scale ranging from 0 to 100. Higher scores indicate better perceived quality of life. Change in the total transformed score is calculated as the post-intervention score minus the baseline score. |
| Change in binge eating severity | Baseline and after the 16-week intervention | Change in binge eating severity following the 16-week intervention. Binge eating symptoms will be assessed using the Brazilian validated version of the Binge Eating Scale (BES; Escala de Compulsão Alimentar Periódica \[ECAP\]). The instrument comprises 16 groups of statements addressing behavioral and affective features of binge eating. The total score ranges from 0 to 46, with higher scores indicating greater binge eating severity. The outcome will be analyzed as the change in total ECAP score from baseline to post-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 the predominant stage of readiness to modify dysfunctional eating behavior from baseline to post-intervention is assessed using the Brazilian adapted and validated version of the University of Rhode Island Change Assessment (URICA) for compulsive eating. The instrument comprises 24 items rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), and assesses four stages of the Transtheoretical Model of Change: precontemplation, contemplation, action, and maintenance. Responses are scored according to the instrument's scoring procedure to identify each participant's predominant motivational stage. The outcome is the change in predominant readiness-to-change stage from baseline to post-intervention, with progression toward action and maintenance indicating greater readiness and engagement in behavior change. |
| Change in Appraisal of Self-Care Agency Scale Total Score | Baseline and after 16 weeks of intervention. | Change in self-care capacity from baseline to post-intervention is assessed using the Appraisal of Self-Care Agency Scale (ASA-A). The instrument comprises 24 items assessing self-care agency across physical, cognitive, and social aspects. The total score ranges from 24 to 120 points, with higher scores indicating greater self-care capacity. Change in the ASA-A total score is calculated as the post-intervention score minus the baseline score. |
| Change in Total Daily Energy Intake | Baseline and after 16 weeks of intervention. | Change in total daily energy intake from baseline to post-intervention is estimated from food records. Total daily energy intake is expressed in kilocalories per day (kcal/day). Change is calculated as the post-intervention value minus the baseline value. |
| Change in Protein Intake | Baseline and post-intervention at week 16. | Change in daily protein intake from baseline to post-intervention. Protein intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Carbohydrate Intake | Baseline and post-intervention at week 16. | Change in daily carbohydrate intake from baseline to post-intervention. Carbohydrate intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Fat Intake | Baseline and post-intervention at week 16. | Change in daily fat intake from baseline to post-intervention. Fat intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value. |
| Change in Relative Autonomy Index for Exercise Motivation | Baseline and after 16 weeks of intervention. | Change in exercise motivational regulation from baseline to post-intervention is assessed using the Brazilian version of the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The instrument comprises 23 items assessing six forms of behavioral regulation: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Items are rated on a 5-point Likert scale ranging from 0 ("not true for me") to 4 ("very true for me"). A Relative Autonomy Index (RAI) is calculated from the six motivational regulation subscale scores using the following weighting: (-3 × amotivation) + (-2 × external regulation) + (-1 × introjected regulation) + (1 × identified regulation) + (2 × integrated regulation) + (3 × intrinsic motivation). Higher and more positive RAI scores indicate a more autonomous motivational profile for exercise. Change in RAI is calculated as the post-intervention score minus the baseline score. |
| Change in Basic Psychological Needs in Exercise Scale Overall Score | Baseline and after 16 weeks of intervention. | Change in basic psychological needs satisfaction in the exercise context from baseline to post-intervention is assessed using the Brazilian version of the Basic Psychological Needs in Exercise Scale (BPNES). The instrument comprises 12 items covering three psychological needs: autonomy, competence, and relatedness, with 4 items assessing each need. Items are rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). For this outcome, an overall BPNES score is calculated as the mean of the 12 items, ranging from 1 to 5. Higher scores indicate greater overall satisfaction of basic psychological needs in the exercise context. Change in the overall BPNES score is calculated as the post-intervention score minus the baseline score. |
Countries
Brazil
Contacts
CONTACTMariana S Januário, Bachelor's degree
PRINCIPAL_INVESTIGATORVitor S Painelli, Dr.
UniCesumar - Centro Universitário Cesumar
Outcome results
None listed