NCT07820774 Multimodal Intervention for Weight Management and Health in the Elderly Population
| NCT ID | NCT07820774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Cesumar (UNICESUMAR) |
| Condition | Obesity & Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-09-14 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2026-09-14 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Vitor S Painelli, Dr.
PRINCIPAL INVESTIGATOR
UniCesumar - Centro Universitário Cesumar
Frequently Asked Questions
Who can join the NCT07820774 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Obesity & Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07820774 currently recruiting?
Yes, NCT07820774 is actively recruiting participants. Contact the research team at marianapsicologaesporte@gmail.com for enrollment information.
Where is the NCT07820774 trial being conducted?
This trial is being conducted at Maringá, Brazil.
Who is sponsoring the NCT07820774 clinical trial?
NCT07820774 is sponsored by Universidade Cesumar (UNICESUMAR). The principal investigator is Vitor S Painelli, Dr. at UniCesumar - Centro Universitário Cesumar. The trial plans to enroll 54 participants.
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