Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obesity Only; Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity who are 65 years and older.	Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes; 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.
Experimental: Sarcopenia and Obesity; Assess the effect of an intensive lifestyle intervention on cognitive function in adults with obesity and sarcopenia who are 65 years and older.	Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Baseline and 17 weeks
Change in weight in kg	Change in weight in kg	Baseline and 17 weeks
Change in body mass index (BMI) in kg/m^2	Change in body mass index (BMI) in kg/m^2	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.	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.	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.	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.	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.	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)	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.	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.	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.	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.	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.	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.	Baseline and 17 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Robert M Roth, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: obesity; cognition; weight loss; sarcopenia; lifestyle
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: D19091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No