Multimodal Intervention for Weight Management and Health in the Elderly Population

NCT07820774 | Not Yet Recruiting

• 1 other identifier: 89619825.6.0000.5539
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity & Overweight

Keywords

obesity; aging; resistance training; high-protein diet; cognitive-behavioral therapy; self-determination

Outcome Measures

Primary Outcomes (1)

• Change in Fat-Free Mass

  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.

  Baseline and after 16 weeks of intervention.

Secondary Outcomes (46)

• 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.

Other Outcomes (1)

• Participant-reported experience and acceptability of the intervention (qualitative)

  At the end of the 16-week intervention (post-intervention)

Study Arms (3)

GUNI - Unimodal Intervention

ACTIVE COMPARATOR

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.

Behavioral: Resistance Training Program

GBI - Bimodal Intervention

EXPERIMENTAL

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.

Behavioral: Group Cognitive Behavioral Therapy Intervention; Behavioral: Resistance Training Program

GINT - Multimodal/Interdisciplinary Intervention

EXPERIMENTAL

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.

Behavioral: Nutritional guidance focused on adopting a high-protein diet.; Behavioral: Group Cognitive Behavioral Therapy Intervention; Behavioral: Resistance Training Program

Interventions

Nutritional guidance focused on adopting a high-protein diet. BEHAVIORAL

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.

GINT - Multimodal/Interdisciplinary Intervention

Group Cognitive Behavioral Therapy Intervention BEHAVIORAL

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.

GBI - Bimodal Intervention; GINT - Multimodal/Interdisciplinary Intervention

Resistance Training Program BEHAVIORAL

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.

GBI - Bimodal Intervention; GINT - Multimodal/Interdisciplinary Intervention; GUNI - Unimodal Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cesumar (UNICESUMAR): lead

Study Sites (1)

UniCesumar - Centro Universitário Cesumar, Maringá, Paraná 87050-900

Maringá, Brazil

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vitor S Painelli, Dr.

  UniCesumar - Centro Universitário Cesumar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana S Januário, Bachelor's degree

CONTACT

+5544991042906; marianapsicologaesporte@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 15, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): August 5, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)