Clinical trial NCT03926481: Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Official title: Evaluation of the Healthy Lifestyle Program on Cognitive Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: weight loss
cognition
sarcopenia
obesity
lifestyle
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in grip strength
timeFrame: Baseline and 17 weeks
measure: Change in 5 times Sit-to-Stand (STS)
timeFrame: Baseline and 17 weeks
measure: Change in Six-Minute Walk Test (6MWT)
timeFrame: Baseline and 17 weeks
measure: Change in weight in kg
timeFrame: Baseline and 17 weeks
measure: Change in body mass index (BMI) in kg/m^2
timeFrame: Baseline and 17 weeks
measure: Change in subject processing speed
timeFrame: Baseline and 17 weeks
measure: Change in language function
timeFrame: Baseline and 17 weeks
measure: Change in subject cognition
timeFrame: Baseline and 17 weeks
measure: Change in subject executive function
timeFrame: Baseline and 17 weeks
measure: Change in speed processing
timeFrame: Baseline and 17 weeks
measure: Change in subject memory
timeFrame: Baseline and 17 weeks
measure: Change in Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Baseline and 17 weeks
measure: Change from baseline Anxiety Symptoms at 17 weeks
timeFrame: Baseline and 17 weeks
measure: Change from baseline Mood Symptoms at 17 weeks
timeFrame: Baseline and 17 weeks
measure: Change from baseline Subjective Health Status (PROMIS) at 17 weeks
timeFrame: Baseline and 17 weeks
measure: Change in Behavior Rating Inventory of Executive Function (BRIEF-A)
timeFrame: Baseline and 17 weeks
measure: Change in Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: Baseline and 17 weeks
Secondary outcomes:
measure: Baseline estimated level of intellectual ability
timeFrame: Baseline
measure: Handedness as measured by Edinburgh Handedness Inventory at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Robert M Roth, PhD
role: PRINCIPAL_INVESTIGATOR
References: