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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes

Clinicaltrials.gov identifier NCT03926481

Recruitment Status Active, not recruiting

First Posted April 24, 2019

Last update posted September 16, 2020

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.

  • Condition or Disease:Obesity
  • Intervention/Treatment: Behavioral: Evaluate Healthy Lifestyle Program on cognitive outcomes
  • Phase: N/A
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 2021 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
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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
  • 4. Change in weight in kg [ Time Frame: Baseline and 17 weeks ]
    Change in weight in kg
  • 5. 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
  • 6. 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.
  • 7. 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.
  • 8. 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.
  • 9. 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.
  • 10. 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.
  • 11. 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)
  • 12. 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.
  • 13. 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.
  • 14. 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.
  • 15. 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.
  • 16. 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.
  • 17. 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.
  • Secondary Outcome Measures: 1. Baseline estimated level of intellectual ability [ Time Frame: Baseline ]
    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.
  • 2. Handedness as measured by Edinburgh Handedness Inventory at Baseline [ Time Frame: Baseline ]
    A self report questionnaire assessing the dominance of one's right or left hand in everyday activities.
Eligibility Criteria
  • Ages Eligible for Study: 65 Years and older (Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts
Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

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

More Information
  • Responsible Party: Dartmouth-Hitchcock Medical Center
  • ClinicalTrials.gov Identifier: NCT03926481 History of Changes
  • Other Study ID Numbers: D19091
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 16, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Dartmouth-Hitchcock Medical Center: weight loss
    cognition
    sarcopenia
    obesity
    lifestyle
  • Additional relevant MeSH terms: Obesity