Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes

NCT03926481 | Terminated

• 1 other identifier: D19091
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

weight loss; cognition; sarcopenia; obesity; lifestyle

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (2)

• Baseline estimated level of intellectual ability

  Baseline

• Handedness as measured by Edinburgh Handedness Inventory at Baseline

  Baseline

Study Arms (2)

Obesity Only

EXPERIMENTAL

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

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.

Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes

Interventions

Evaluate Healthy Lifestyle Program on cognitive outcomes BEHAVIORAL

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.

Obesity Only; Sarcopenia and Obesity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to perform measures
• Individuals unwilling/unable to provide consent
• Severe mental or life-threatening illness
• History of bariatric surgery

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Sarcopenia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Robert M Roth, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 24, 2019
• Study Start: July 10, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)