- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685305
Weight Loss and Cognitive Function in Adults
Weight Loss and Cognitive Function in Middle-Aged and Older Adults
More than two-thirds of middle-aged and older adults are overweight, which places them at greater risk of disability and higher medical expenses. Lifestyle interventions which promote weight loss for this population are needed. However, it is not known how different weight loss approaches impact brain (cognitive) functions, such as memory and attention. The investigator's investigation aims to improve adherence to a hypocaloric diet prescription through improved attention and inhibitory control, reduced hunger, and increased satiety.
The objectives of this pilot study are to: 1) determine the feasibility and establish proof-of-concept; 2) establish proficiency and feasibility of the proposed cognitive function assessments; and 3) obtain preliminary data for effect size generation.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Tech
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Overweight or obese, BMI 25-40 kg/m^2
- Able to use a computer, keyboard, and mouse
Exclusion Criteria:
- Uncontrolled hypertension
- Orthopedic injury
- Other conditions that preclude participation in a walking program
- Previous participation in psychology research which involved computerized cognitive testing
- Diabetes which requires insulin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypocaloric diet with hunger reduction strategy
Participants will be prescribed a hypocaloric diet with additional instructions to promote hunger reduction.
The hypocaloric diet will range 1200-1500 kcal/d, and will be based upon the 2015 US Dietary Guidelines for Americans.
Dietary instructions will be provided by a Registered Dietitian.
|
Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase.
Counseling will include specific instructions on a dietary manipulation which may reduce hunger, in order to facilitate dietary adherence.This will include tracking of the strategy.
They will also be provided a pedometer and instructed to attain 10,000 steps per day.
|
Active Comparator: Hypocaloric diet without hunger reduction strategy
Participants will only be prescribed a hypocaloric diet.
The hypocaloric diet will range 1200-1500 kcal/d, and will be based upon the 2015 US Dietary Guidelines for Americans.
Dietary instructions will be provided by a Registered Dietitian.
|
Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase.
They will also be provided a pedometer and instructed to attain 10,000 steps per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function changes - attention
Time Frame: 30-min measurement per session
|
Computerized tasks will score each participant's performance for attention at baseline and after both the 4-week weight loss and weight maintenance phases.
|
30-min measurement per session
|
Cognitive function changes - inhibitory control
Time Frame: 30-min measurement per session
|
Computerized tasks will score each participant's performance for inhibitory control at baseline and after both the 4-week weight loss and weight maintenance phases.
|
30-min measurement per session
|
Weight change
Time Frame: 5-min measurement per session
|
Weight will be measured on a scale at baseline and after both the 4-week weight loss and weight maintenance phases.
|
5-min measurement per session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived hunger
Time Frame: 15-minute measurement per session
|
The Visual Analog Scale (VAS) survey will be used to measure hunger at baseline and after both the 4-week weight loss and weight maintenance phases.
Participants make a mark on a 100 mm line that corresponds to their subjective feelings (range of score is 0-100).
The line is anchored by descriptors that are polar opposites (not at all hungry to extremely hungry).
The score is determined by using the place on the line where the mark is made by the participants.
|
15-minute measurement per session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brenda Davy, PhD, Virginia Polytechnic Institute and State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-462
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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