Weight Loss and Cognitive Function in Adults

NCT ID: NCT03685305

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Hypocaloric diet with hunger reduction strategy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Hypocaloric diet without hunger reduction strategy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Brenda Davy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brenda Davy, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

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Virginia Tech

Blacksburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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18-462

Identifier Type: -

Identifier Source: org_study_id

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