ObesityNCT03926481
Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
A study testing Evaluate Healthy Lifestyle Program on cognitive outcomes in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this study is to conduct a program of pilot research aimed at evaluating the effect of an intensive lifestyle intervention on cognitive functioning in older adults with obesity and or obesity and sarcopenia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Evaluate Healthy Lifestyle Program on cognitive outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- English Speaking
- Age ≥65 years
- Body Composition Body Fat >25% for Men
- Body Composition Body Fat >30% for Women
- Participating in the Dartmouth Hitchcock Weight and Wellness Center (WWC) Healthy Lifestyle Program (HLP)
- Willing and able to give informed consent
Who cannot join
- Unable to perform measures
- Individuals unwilling/unable to provide consent
- Severe mental or life-threatening illness
- History of bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
The goal of this study is to conduct a program of pilot research aimed at evaluating the effect of an intensive lifestyle intervention on cognitive functioning in older adults with obesity and or obesity and sarcopenia.
Read the detailed description
Detailed Description:
The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. The overarching goal of this study is to conduct a program of pilot research aimed at evaluating the effect of a intensive lifestyle intervention on cognitive functioning in order adults with obesity and or obesity and sarcopenia. While some degree of cognitive decline is common during the normal aging process, epidemiological evidence suggests that obesity can promote its acceleration. It is unclear the effect that intensive lifestyle changes could have on cognitive functioning in older adults with obesity.
Study Timeline:
May 2019 to May 2023
Goal: Conduct a study to evaluate the effects that intensive lifestyle program has on cognitive functioning in older adults with obesity and or obesity and sarcopenia.
Participation Duration: Participants will meet weekly for 17 weeks. Cognitive assessments will take place at baseline and 17 weeks.
- Conditions
- Obesity
- Being tested
- Evaluate Healthy Lifestyle Program on cognitive outcomes
- Keywords
- weight loss, cognition, sarcopenia, obesity, lifestyle
- Medical subject headings
- Obesity, Weight Loss, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate Healthy Lifestyle Program on cognitive outcomesBehavioural
The healthy lifestyle program will be delivered once a week for 17 weeks as part as regular clinical care. It will include an group classes taught by health coaches and dieticians. These classes will focus on diet, exercise, and behavior modification. We plan 2 cohorts of 15 subjects (n=30). In-person research assistant-led assessments will occur at baseline and 17 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Obesity Only | Experimental | Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older. Receives: Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes |
| Sarcopenia and Obesity | Experimental | Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older. Receives: Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grip strength
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. A higher score represents a better outcome.
Measured: Baseline and 17 weeks
Change in 5 times Sit-to-Stand (STS)
STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome.
Measured: Baseline and 17 weeks
Change in Six-Minute Walk Test (6MWT)
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Measured: Baseline and 17 weeks
Change in weight in kg
Change in weight in kg
Measured: Baseline and 17 weeks
Change in body mass index (BMI) in kg/m^2
Change in body mass index (BMI) in kg/m^2
Measured: Baseline and 17 weeks
Change in subject processing speed
Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.
Measured: Baseline and 17 weeks
Change in language function
Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance.
Measured: Baseline and 17 weeks
Change in subject cognition
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.
Measured: Baseline and 17 weeks
Change in subject executive function
Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300.
Measured: Baseline and 17 weeks
Change in speed processing
Trail making Test-A\&B is used to assess information processing speed. Shorter time indicates better performance.
Measured: Baseline and 17 weeks
Change in subject memory
California Verbal Learning Test II (CVLT-II) Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome)
Measured: Baseline and 17 weeks
Change in Brief Visuospatial Memory Test-Revised (BVMT-R)
BVMT-R is used to evaluate spatial memory ability. Scores range from 0 to 60, with higher values indicating better performance.
Measured: Baseline and 17 weeks
Change from baseline Anxiety Symptoms at 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.
Measured: Baseline and 17 weeks
Change from baseline Mood Symptoms at 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.
Measured: Baseline and 17 weeks
Change from baseline Subjective Health Status (PROMIS) at 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.
Measured: Baseline and 17 weeks
Change in Behavior Rating Inventory of Executive Function (BRIEF-A)
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.
Measured: Baseline and 17 weeks
Change in Prospective and Retrospective Memory Questionnaire (PRMQ)
PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64.
Measured: Baseline and 17 weeks
Secondary outcomes (2)
Baseline estimated level of intellectual ability
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.
Measured: Baseline
Handedness as measured by Edinburgh Handedness Inventory at Baseline
A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start10 Jul 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Roth, Dartmouth-Hitchcock Medical Center
- Investigators
- Robert M Roth, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926481
- Sponsor's protocol ID
- D19091
- Status last verified
- Aug 2022
- First submitted
- 23 Apr 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
- ClinicalTrials.gov ID
- NCT03926481
- Acronym / sponsor ID
- D19091
- Conditions
- Obesity
- Keywords
- weight loss, cognition, sarcopenia, obesity, lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to conduct a program of pilot research aimed at evaluating the effect of an intensive lifestyle intervention on cognitive functioning in older adults with obesity and or obesity and sarcopenia.
Detailed description
Detailed Description:
The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. The overarching goal of this study is to conduct a program of pilot research aimed at evaluating the effect of a intensive lifestyle intervention on cognitive functioning in order adults with obesity and or obesity and sarcopenia. While some degree of cognitive decline is common during the normal aging process, epidemiological evidence suggests that obesity can promote its acceleration. It is unclear the effect that intensive lifestyle changes could have on cognitive functioning in older adults with obesity.
Study Timeline:
May 2019 to May 2023
Goal: Conduct a study to evaluate the effects that intensive lifestyle program has on cognitive functioning in older adults with obesity and or obesity and sarcopenia.
Participation Duration: Participants will meet weekly for 17 weeks. Cognitive assessments will take place at baseline and 17 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity Only | Experimental | Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomesAssess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older. |
| Sarcopenia and Obesity | Experimental | Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomesAssess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- English Speaking
- Age ≥65 years
- Body Composition Body Fat >25% for Men
- Body Composition Body Fat >30% for Women
- Participating in the Dartmouth Hitchcock Weight and Wellness Center (WWC) Healthy Lifestyle Program (HLP)
Key exclusion criteria (4 listed)
- Unable to perform measures
- Individuals unwilling/unable to provide consent
- Severe mental or life-threatening illness
- History of bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate Healthy Lifestyle Program on cognitive outcomesThe healthy lifestyle program will be delivered once a week for 17 weeks as part as regular clinical care. It will include an group classes taught by health coaches and dieticians. These classes will focus on diet, exercise, and behavior modification. We plan 2 cohorts of 15 subjects (n=30). In-person research assistant-led assessments will occur at baseline and 17 weeks. | Behavioural | Obesity Only, Sarcopenia and Obesity |
Primary outcome
Change in grip strength
Time frame: 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.
Change in 5 times Sit-to-Stand (STS)
Time frame: Baseline and 17 weeks
STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome.
Change in Six-Minute Walk Test (6MWT)
Time frame: 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
Change in weight in kg
Time frame: Baseline and 17 weeks
Change in weight in kg
Change in body mass index (BMI) in kg/m^2
Time frame: Baseline and 17 weeks
Change in body mass index (BMI) in kg/m^2
Change in subject processing speed
Time frame: 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.
Change in language function
Time frame: Baseline and 17 weeks
Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance.
Change in subject cognition
Time frame: 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.
Change in subject executive function
Time frame: Baseline and 17 weeks
Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300.
Change in speed processing
Time frame: Baseline and 17 weeks
Trail making Test-A\&B is used to assess information processing speed. Shorter time indicates better performance.
Change in subject memory
Time frame: 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)
Change in Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: 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.
Change from baseline Anxiety Symptoms at 17 weeks
Time frame: 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.
Change from baseline Mood Symptoms at 17 weeks
Time frame: 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.
Change from baseline Subjective Health Status (PROMIS) at 17 weeks
Time frame: 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.
Change in Behavior Rating Inventory of Executive Function (BRIEF-A)
Time frame: 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.
Change in Prospective and Retrospective Memory Questionnaire (PRMQ)
Time frame: Baseline and 17 weeks
PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64.
2 secondary outcomes
Baseline estimated level of intellectual ability
Time frame: Baseline
Handedness as measured by Edinburgh Handedness Inventory at Baseline
Time frame: Baseline
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Roth, PhD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate Healthy Lifestyle Program on cognitive outcomes in people with Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grip strength (time frame: Baseline and 17 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.