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Clinical Trials/NCT03926481
NCT03926481TerminatedNot Applicable

Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes

Dartmouth-Hitchcock Medical Center1 site in 1 country6 target enrollmentStarted: July 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
6
Locations
1
Primary Endpoint
Change in subject executive function

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Obesity Only

Experimental

Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older.

Intervention: Evaluate Healthy Lifestyle Program on cognitive outcomes (Behavioral)

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.

Intervention: Evaluate Healthy Lifestyle Program on cognitive outcomes (Behavioral)

Outcomes

Primary Outcomes

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 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 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 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 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.

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 weight in kg

Time Frame: Baseline and 17 weeks

Change in weight in kg

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 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 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 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 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 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 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.

Secondary Outcomes

  • Baseline estimated level of intellectual ability(Baseline)
  • Handedness as measured by Edinburgh Handedness Inventory at Baseline(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert M. Roth

Associate Professor of Psychiatry

Dartmouth-Hitchcock Medical Center

Study Sites (1)

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