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Weight Loss and Cognitive Function in Adults

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypocaloric diet with hunger reduction strategy
Hypocaloric diet without hunger reduction strategy
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Weight loss, Cognitive function, Weight maintenance

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Tech

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypocaloric diet with hunger reduction strategy

Hypocaloric diet without hunger reduction strategy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Cognitive function changes - attention
Computerized tasks will score each participant's performance for attention at baseline and after both the 4-week weight loss and weight maintenance phases.
Cognitive function changes - inhibitory control
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.
Weight change
Weight will be measured on a scale at baseline and after both the 4-week weight loss and weight maintenance phases.

Secondary Outcome Measures

Perceived hunger
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.

Full Information

First Posted
August 27, 2018
Last Updated
August 22, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT03685305
Brief Title
Weight Loss and Cognitive Function in Adults
Official Title
Weight Loss and Cognitive Function in Middle-Aged and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Weight loss, Cognitive function, Weight maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypocaloric diet with hunger reduction strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypocaloric diet without hunger reduction strategy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric diet with hunger reduction strategy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric diet without hunger reduction strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive function changes - attention
Description
Computerized tasks will score each participant's performance for attention at baseline and after both the 4-week weight loss and weight maintenance phases.
Time Frame
30-min measurement per session
Title
Cognitive function changes - inhibitory control
Description
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.
Time Frame
30-min measurement per session
Title
Weight change
Description
Weight will be measured on a scale at baseline and after both the 4-week weight loss and weight maintenance phases.
Time Frame
5-min measurement per session
Secondary Outcome Measure Information:
Title
Perceived hunger
Description
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.
Time Frame
15-minute measurement per session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Davy, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States

12. IPD Sharing Statement

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Weight Loss and Cognitive Function in Adults

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