Multimodal Intervention for Weight Management and Health in the Elderly Population
NCT07820774, Not applicable, Recruiting, Universidade Cesumar (UNICESUMAR)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multimodal Intervention for Weight Management and Health in the Elderly Population | ClinicalTrials.gov |
| NCT number | NCT07820774 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 54 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidade Cesumar (UNICESUMAR) | ClinicalTrials.gov |
| Conditions | Obesity & Overweight | ClinicalTrials.gov |
| Interventions | Nutritional guidance focused on adopting a high-protein diet., Group Cognitive Behavioral Therapy Intervention, Resistance Training Program | ClinicalTrials.gov |
| First posted | 2026-09-15 | ClinicalTrials.gov |
| Last updated | 2026-10-20 | ClinicalTrials.gov |
Registered outcomes 48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)