Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
NCT03926481, Not applicable, Terminated, Dartmouth-Hitchcock Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes | ClinicalTrials.gov |
| NCT number | NCT03926481 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 6 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Dartmouth-Hitchcock Medical Center | ClinicalTrials.gov |
| Conditions | Obesity | ClinicalTrials.gov |
| Interventions | Evaluate Healthy Lifestyle Program on cognitive outcomes | ClinicalTrials.gov |
| First posted | 2019-04-24 | ClinicalTrials.gov |
| Last updated | 2022-08-03 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in grip strength | Baseline and 17 weeks | Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. A higher score represents a better outcome. | ClinicalTrials.gov |
| Primary | Change in 5 times Sit-to-Stand (STS) | Baseline and 17 weeks | STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome. | ClinicalTrials.gov |
| Primary | Change in Six-Minute Walk Test (6MWT) | Baseline and 17 weeks | A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m | ClinicalTrials.gov |
| Primary | Change in weight in kg | Baseline and 17 weeks | Change in weight in kg | ClinicalTrials.gov |
| Primary | Change in body mass index (BMI) in kg/m^2 | Baseline and 17 weeks | Change in body mass index (BMI) in kg/m\^2 | ClinicalTrials.gov |
| Primary | Change in subject processing speed | Baseline and 17 weeks | Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome. | ClinicalTrials.gov |
| Primary | Change in language function | Baseline and 17 weeks | Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance. | ClinicalTrials.gov |
| Primary | Change in subject cognition | Baseline and 17 weeks | Verbal fluency test is used to evaluate language function. Performance will be identified via the total number of appropriate words responded on each of the task. Higher score indicates better performance. | ClinicalTrials.gov |
| Primary | Change in subject executive function | Baseline and 17 weeks | Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300. | ClinicalTrials.gov |
| Primary | Change in speed processing | Baseline and 17 weeks | Trail making Test-A\&B is used to assess information processing speed. Shorter time indicates better performance. | ClinicalTrials.gov |
| Primary | Change in subject memory | Baseline and 17 weeks | California Verbal Learning Test II (CVLT-II) Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome) | ClinicalTrials.gov |
| Primary | Change in Brief Visuospatial Memory Test-Revised (BVMT-R) | Baseline and 17 weeks | BVMT-R is used to evaluate spatial memory ability. Scores range from 0 to 60, with higher values indicating better performance. | ClinicalTrials.gov |
| Primary | Change from baseline Anxiety Symptoms at 17 weeks | Baseline and 17 weeks | will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety. | ClinicalTrials.gov |
| Primary | Change from baseline Mood Symptoms at 17 weeks | Baseline and 17 weeks | Will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression. | ClinicalTrials.gov |
| Primary | Change from baseline Subjective Health Status (PROMIS) at 17 weeks | Baseline and 17 weeks | Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher score indicated more positive perceptions of overall health. | ClinicalTrials.gov |
| Primary | Change in Behavior Rating Inventory of Executive Function (BRIEF-A) | Baseline and 17 weeks | Behavior Rating Inventory of Executive Function (BREIF-A) is used to evaluate executive functioning.This questionnaire consist of 75 items on which the patient's symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties. | ClinicalTrials.gov |
| Primary | Change in Prospective and Retrospective Memory Questionnaire (PRMQ) | Baseline and 17 weeks | PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64. | ClinicalTrials.gov |
| Secondary | Baseline estimated level of intellectual ability | Baseline | Test of Premorbid Functioning which results in a total raw score ranging from 0-70, and is normatively scored based on respondents' age resulting in standard scores (mean = 100). Higher values indicate a higher premorbid level of intellect. | ClinicalTrials.gov |
| Secondary | Handedness as measured by Edinburgh Handedness Inventory at Baseline | Baseline | A self report questionnaire assessing the dominance of one's right or left hand in everyday activities. | 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 6
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 |
|---|---|---|
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary 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)