Overweight and ObesityNCT03685305
Weight Loss and Cognitive Function in Adults
A study testing Hypocaloric diet with hunger reduction strategy and Hypocaloric diet without hunger reduction strategy in people with Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Hypocaloric diet with hunger reduction strategy and Hypocaloric diet without hunger reduction strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese, BMI 25-40 kg/m^2
- Able to use a computer, keyboard, and mouse
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss and Cognitive Function in Middle-Aged and Older 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.
- Conditions
- Overweight and Obesity
- Being tested
- Hypocaloric diet with hunger reduction strategy, Hypocaloric diet without hunger reduction strategy
- Keywords
- Weight loss, Cognitive function, Weight maintenance
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric diet with hunger reduction strategyBehavioural
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 strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hypocaloric diet without hunger reduction strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5-min measurement per session
Secondary outcomes (1)
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.
Measured: 15-minute measurement per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start6 Aug 2018
- Primary completion14 Aug 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Davy, Virginia Polytechnic Institute and State University
- Investigators
- Brenda Davy, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685305
- Sponsor's protocol ID
- 18-462
- Status last verified
- Mar 2025
- First submitted
- 27 Aug 2018
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Cognitive Function in Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT03685305
- Acronym / sponsor ID
- 18-462
- Conditions
- Overweight and Obesity
- Keywords
- Weight loss, Cognitive function, Weight maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypocaloric diet with hunger reduction strategy | Experimental | Behavioral: Hypocaloric diet with hunger reduction strategyParticipants 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. |
| Hypocaloric diet without hunger reduction strategy | Active comparator | Behavioral: Hypocaloric diet without hunger reduction strategyParticipants 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight or obese, BMI 25-40 kg/m^2
- Able to use a computer, keyboard, and mouse
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypocaloric diet with hunger reduction strategyParticipants 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. | Behavioural | Hypocaloric diet with hunger reduction strategy |
| Hypocaloric diet without hunger reduction strategyParticipants 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. | Behavioural | Hypocaloric diet without hunger reduction strategy |
Primary outcome
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.
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.
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.
1 secondary outcome
Perceived hunger
Time frame: 15-minute measurement per session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Davy, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric diet with hunger reduction strategy and Hypocaloric diet without hunger reduction strategy in people with Overweight and Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function changes - attention (time frame: 30-min measurement per session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.