Skip to content

Weight Loss and Cognitive Function in Adults

Weight Loss and Cognitive Function in Middle-Aged and Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03685305
Enrollment
33
Registered
2018-09-26
Start date
2018-08-06
Completion date
2020-03-31
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Weight loss, Cognitive function, Weight maintenance

Brief summary

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.

Interventions

BEHAVIORALHypocaloric diet with hunger reduction strategy

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.

BEHAVIORALHypocaloric diet without hunger reduction strategy

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.

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cognitive function changes - inhibitory control30-min measurement per sessionComputerized tasks will score each participant's performance for inhibitory control at baseline and after both the 4-week weight loss and weight maintenance phases.
Cognitive function changes - attention30-min measurement per sessionComputerized tasks will score each participant's performance for attention at baseline and after both the 4-week weight loss and weight maintenance phases.
Weight change5-min measurement per sessionWeight will be measured on a scale at baseline and after both the 4-week weight loss and weight maintenance phases.

Secondary

MeasureTime frameDescription
Perceived hunger15-minute measurement per sessionThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026