Midlife Obese Adults With Cognitive DeclineGetSmartNCT05388318
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
A study testing Prolonged nightly fasting in people with Midlife Obese Adults With Cognitive Decline, run by Arizona State University at 1 site in United States.
Trial summary
Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function… Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Midlife Obese Adults With Cognitive Decline
- What is being tested?
- Prolonged nightly fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to 31 Aug 2023
- 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 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40-59 years old
- experiencing memory loss
- BMI 30-45.9
- PSS-4 score ≥5
- access to smartphone, zoom, and wifi
- lives in United States
Who cannot join
- diabetes
- pregnant,
- neurological disorder
- eating disorder within last 20 years
- In current weight loss program
- previously had bariatric surgery
- works a night shit
- health condition not conducive to nightly fasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults
Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.
- Being tested
- Prolonged nightly fasting, Health Education Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged nightly fastingBehavioural
14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.
Health Education ControlBehavioural
Weekly health education video viewing related to general health topics
| Study group | Role | What they receive |
|---|---|---|
| Prolonged nightly fasting (PNF) | Experimental | Not described Receives: Behavioral: Prolonged nightly fasting |
| Health Education Control (HEC) | Active comparator | Not described Receives: Behavioral: Health Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telephone Montreal Cognitive Assessment
T-MoCA, a measure of cognitive function
Measured: 8 weeks
Every Day Cognition-12
ECOG-12, a measure of cognitive function
Measured: 8 weeks
Secondary outcomes (5)
Perceived Stress Scale- 10
PSS-10, a measure of perceived stress
Measured: 8 weeks
Rapid Eating Assessment for Participants
REAPS, a measure of eating behaviors
Measured: 8 weeks
Creature of Habit Scale
COHS, a measure of habitual behavior
Measured: 8 weeks
Three-Factor Eating Questionnaire-Revised
TFEQ, a measure of eating behaviors
Measured: 8 weeks
Pittsburgh Sleep Quality Index
PSQI, a measure of sleep quality
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start17 Mar 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midlife Obese Adults With Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 groups (intervention and control).
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388318
- Sponsor's protocol ID
- 00015014
- Acronym
- GetSmart
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults
- ClinicalTrials.gov ID
- NCT05388318
- Acronym / sponsor ID
- GetSmart / 00015014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 24 May 2022 (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.
Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 groups (intervention and control).
| Arm | Type | Receives |
|---|---|---|
| Prolonged nightly fasting (PNF) | Experimental | Behavioral: Prolonged nightly fasting |
| Health Education Control (HEC) | Active comparator | Behavioral: Health Education Control |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 40-59 years old
- experiencing memory loss
- BMI 30-45.9
- PSS-4 score ≥5
- access to smartphone, zoom, and wifi
Key exclusion criteria (8 listed)
- diabetes
- pregnant,
- neurological disorder
- eating disorder within last 20 years
- In current weight loss program
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 |
|---|---|---|
| Prolonged nightly fasting14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration. | Behavioural | Prolonged nightly fasting (PNF) |
| Health Education ControlWeekly health education video viewing related to general health topics | Behavioural | Health Education Control (HEC) |
Primary outcome
Telephone Montreal Cognitive Assessment
Time frame: 8 weeks
T-MoCA, a measure of cognitive function
Every Day Cognition-12
Time frame: 8 weeks
ECOG-12, a measure of cognitive function
5 secondary outcomes
Perceived Stress Scale- 10
Time frame: 8 weeks
Rapid Eating Assessment for Participants
Time frame: 8 weeks
Creature of Habit Scale
Time frame: 8 weeks
Three-Factor Eating Questionnaire-Revised
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
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 29 Jan 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged nightly fasting in people with Midlife Obese Adults With Cognitive Decline, run by Arizona 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 6 inclusion and 8 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 29 Jan 2024. 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?
Telephone Montreal Cognitive Assessment (time frame: 8 weeks). The study lists 2 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 29 Jan 2024.