Weight Loss and Cognitive Function in Adults

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685305
• Other study ID #: 18-462
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2020
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Hypocaloric 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.
• Hypocaloric 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.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30-min measurement per session
Primary	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.	30-min measurement per session
Primary	Weight change	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	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.	15-minute measurement per session