Combined Physical-cognitive Exercise and Dietary Intervention for Postmenopausal Obese Women
NCT04768725, Not applicable, Completed, Chiang Mai University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Combined Physical-cognitive Exercise and Dietary Intervention for Postmenopausal Obese Women | ClinicalTrials.gov |
| NCT number | NCT04768725 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 92 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Chiang Mai University | ClinicalTrials.gov |
| Conditions | Obesity | ClinicalTrials.gov |
| Interventions | Dietary intervention combined with physical-cognitive exergaming, Dietary intervention, Physical-cognitive intervention | ClinicalTrials.gov |
| First posted | 2021-02-24 | ClinicalTrials.gov |
| Last updated | 2023-02-14 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | change from baseline time to complete Trail Making B-A at 12 weeks | 12 weeks | Time to complete Trail Making B and A will be recorded in seconds. The difference between time to complete Trail B and A will be used to index the task switching ability, a subdomain of executive function. Smaller differences between B-A indicate better switching ability. | ClinicalTrials.gov |
| Primary | change from baseline Stroop Color and Word score at 12 weeks | 12 weeks | In Stroop Color and Word test, the number of items correctly identified in 45 seconds in each condition (i.e. word, color, color-word) will be recorded. Then the predicted score will be calculated. Score will be obtained from the different between the color-word and predicted scores. Lower scores indicate greater difficulty in inhibiting interference. | ClinicalTrials.gov |
| Primary | change from baseline Logical Memory score at 12 weeks | 12 weeks | In Logical Memory test, participants will be instructed to listen carefully to two stories and remember their contents. After a 30-delay, they will be asked to freely recall the passages (recall) and respond yes or no to the given questions (recognition). The possible scores are 0-75. Higher scores indicate better episodic memory. | ClinicalTrials.gov |
| Primary | change from baseline Brain-derived neurotrophic factor (BDNF) level at 12 weeks | 12 weeks | Level of plasma BDNF will be determined before and after the intervention. | ClinicalTrials.gov |
| Secondary | change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks | 12 weeks | The Montreal Cognitive Assessment will be used to index global cognitive function. The possible scores are 0-30. Higher scores indicate better cognitive function. | ClinicalTrials.gov |
| Secondary | change from baseline Verbal Fluency score at 12 weeks | 12 weeks | Category fluency subtest (naming test) of Verbal Fluency will be used. Participants will be asked to produce as many words as possible in 60 seconds. Higher scores indicate better language ability. | ClinicalTrials.gov |
| Secondary | change from baseline Digit Span score at 12 weeks | 12 weeks | In Digit Span test, lists of numbers will be presented orally to participants. They are asked to repeat the numbers immediately in ascending (forward) or reverse (backward) numerical order. The possible scores are 0-28. Higher scores indicate better attention. | ClinicalTrials.gov |
| Secondary | change from baseline plasma adiponectin levels at 12 weeks | 12 weeks | Level of plasma adiponectin will be determined before and after intervention. | ClinicalTrials.gov |
| Secondary | change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks | 12 weeks | Level of plasma IL-6 will be determined before and after intervention. | ClinicalTrials.gov |
| Secondary | change from baseline insulin resistance levels at 12 weeks | 12 weeks | Level of insulin resistance will be assessed using the homeostasis model assessment (HOMA-IR) index \[fasting glucose (mg/dL) X fasting insulin (µU/mL) / 405\]. | ClinicalTrials.gov |
| Secondary | change from baseline Six-minute walk distance at 12 weeks | 12 weeks | The distance (in meters) participants walked in 6 minutes will be determined. Longer distance indicates better cardiorespiratory fitness. | ClinicalTrials.gov |
| Secondary | change from baseline 30 seconds Chair Stand Test at 12 weeks | 12 weeks | The number of repetitions participants could perform sit-to-stand will be recorded. Higher number of repetitions indicates greater lower-body strength. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38443944 | DERIVED | PubMed |
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 7
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 |
|---|---|---|
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)