Weight Loss and Cognitive Function in Adults

February 20, 2024 updated by: Brenda Davy, Virginia Polytechnic Institute and State University

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

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Virginia Tech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brenda Davy, PhD, Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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