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OpenTrials
Completed

NCT Number: NCT03685305

Weight Loss and Cognitive Function in 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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech

Blacksburg, Virginia, 24061, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypocaloric diet with hunger reduction strategy

Behavioral

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

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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