NCT03685305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

August 27, 2018

Last Update Submit

March 20, 2025

Conditions

Overweight and Obesity

Keywords

Weight lossCognitive functionWeight maintenance

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Perceived hunger

    15-minute measurement per session

Study Arms (2)

Hypocaloric diet with hunger reduction strategy

EXPERIMENTAL

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.

Behavioral: Hypocaloric diet with hunger reduction strategy

Hypocaloric diet without hunger reduction strategy

ACTIVE COMPARATOR

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.

Behavioral: Hypocaloric diet without hunger reduction strategy

Interventions

Hypocaloric diet with hunger reduction strategyBEHAVIORAL

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 with hunger reduction strategy
Hypocaloric diet without hunger reduction strategyBEHAVIORAL

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.

Hypocaloric diet without hunger reduction strategy

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight or obese, BMI 25-40 kg/m\^2
  • Able to use a computer, keyboard, and mouse

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Brenda Davy, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2018

First Posted

September 26, 2018

Study Start

August 6, 2018

Primary Completion

August 14, 2019

Study Completion

March 31, 2020

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations

US(1)