Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evaluate Healthy Lifestyle Program on cognitive outcomes
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring weight loss, cognition, sarcopenia, obesity, lifestyle
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to perform measures
- Individuals unwilling/unable to provide consent
- Severe mental or life-threatening illness
- History of bariatric surgery
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Obesity Only
Sarcopenia and Obesity
Arm Description
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older.
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older.
Outcomes
Primary Outcome Measures
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.
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.
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
Change in weight in kg
Change in weight in kg
Change in body mass index (BMI) in kg/m^2
Change in body mass index (BMI) in kg/m^2
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.
Change in language function
Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance.
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.
Change in subject executive function
Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300.
Change in speed processing
Trail making Test-A&B is used to assess information processing speed. Shorter time indicates better performance.
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)
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03926481
First Posted
April 23, 2019
Last Updated
August 1, 2022
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03926481
Brief Title
Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Official Title
Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss, cognition, sarcopenia, obesity, lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obesity Only
Arm Type
Experimental
Arm Description
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older.
Arm Title
Sarcopenia and Obesity
Arm Type
Experimental
Arm Description
Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older.
Intervention Type
Behavioral
Intervention Name(s)
Evaluate Healthy Lifestyle Program on cognitive outcomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in grip strength
Description
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. A higher score represents a better outcome.
Time Frame
Baseline and 17 weeks
Title
Change in 5 times Sit-to-Stand (STS)
Description
STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome.
Time Frame
Baseline and 17 weeks
Title
Change in Six-Minute Walk Test (6MWT)
Description
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m
Time Frame
Baseline and 17 weeks
Title
Change in weight in kg
Description
Change in weight in kg
Time Frame
Baseline and 17 weeks
Title
Change in body mass index (BMI) in kg/m^2
Description
Change in body mass index (BMI) in kg/m^2
Time Frame
Baseline and 17 weeks
Title
Change in subject processing speed
Description
Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome.
Time Frame
Baseline and 17 weeks
Title
Change in language function
Description
Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance.
Time Frame
Baseline and 17 weeks
Title
Change in subject cognition
Description
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.
Time Frame
Baseline and 17 weeks
Title
Change in subject executive function
Description
Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300.
Time Frame
Baseline and 17 weeks
Title
Change in speed processing
Description
Trail making Test-A&B is used to assess information processing speed. Shorter time indicates better performance.
Time Frame
Baseline and 17 weeks
Title
Change in subject memory
Description
California Verbal Learning Test II (CVLT-II) Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome)
Time Frame
Baseline and 17 weeks
Title
Change in Brief Visuospatial Memory Test-Revised (BVMT-R)
Description
BVMT-R is used to evaluate spatial memory ability. Scores range from 0 to 60, with higher values indicating better performance.
Time Frame
Baseline and 17 weeks
Title
Change from baseline Anxiety Symptoms at 17 weeks
Description
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.
Time Frame
Baseline and 17 weeks
Title
Change from baseline Mood Symptoms at 17 weeks
Description
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.
Time Frame
Baseline and 17 weeks
Title
Change from baseline Subjective Health Status (PROMIS) at 17 weeks
Description
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.
Time Frame
Baseline and 17 weeks
Title
Change in Behavior Rating Inventory of Executive Function (BRIEF-A)
Description
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.
Time Frame
Baseline and 17 weeks
Title
Change in Prospective and Retrospective Memory Questionnaire (PRMQ)
Description
PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64.
Time Frame
Baseline and 17 weeks
Secondary Outcome Measure Information:
Title
Baseline estimated level of intellectual ability
Description
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.
Time Frame
Baseline
Title
Handedness as measured by Edinburgh Handedness Inventory at Baseline
Description
A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unable to perform measures
Individuals unwilling/unable to provide consent
Severe mental or life-threatening illness
History of bariatric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Roth, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
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