Overweight and ObesityNCT03956290
Time Restricted EATing (TREAT) Pilot Study
A study testing TREAT pilot intervention in people with Overweight and Obesity and Pre Diabetes, run by Columbia University at 1 site in United States.
Trial summary
The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study. Read more about this study
- Who is it for?
- Ages 45 to 73 years
- Conditions the study is for
- Overweight and Obesity, Pre Diabetes
- What is being tested?
- TREAT pilot intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 11 Jan 2021
- 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 45 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 45-73y old
- overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
- pre-diabetes or diabetes only diet controlled (HbA1c <7%)
- elevated Blood Pressure (BP) 120-129/<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk <10%
- having LDL cholesterol <150mg/dl
- no known sleep, psychiatric or food intake disorders
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- in possession of a smart phone
- English-speaking
- must live in New York city geographical area and not have planned travel schedule interfering with the study
Who cannot join
- history or clinical evidence of condition that affect sleep
- significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
- history of seizure disorder
- being on medications for diabetes, hypertension or dyslipidemia
- previous bariatric surgery
- history or current significant psychiatric disorder
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- use dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
- smoking tobacco or using illegal or recreational drugs
- consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk)
- consume large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day)
- participate in intense exercise (causing heavy breathing and sweating, such as jogging) >2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for >150 min/wk
- shift work
- extreme early and late chronotypes
- unwilling/unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Obesity Nutrition Research Center
New York, New York, 10032-3702
About this study
The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.
Read the detailed description
Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.
Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.
- Conditions
- Overweight and Obesity, Pre Diabetes
- Being tested
- TREAT pilot intervention
- Keywords
- Time restricted eating, Overweight, Obesity, Metabolic syndrome, Diabetes treated with metformin and/or diet and HbA1C< 7%, Pre Diabetes, Circadian rhythm
- Medical subject headings
- Overweight, Obesity, Glucose Intolerance, Intermittent Fasting, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREAT pilot interventionBehavioural
Also called TREAT
Participants will be asked to use the app and take pictures of everything they eat and drink, from the time they get up to the time they go to bed, regardless of size of meal/snacks/drink, for 2 weeks. This will generate data on their eating pattern and eating duration. Participants will be reminded through app, call or text by study staff based on personalized eating schedule. The sleep schedule will also be recorded.
| Study group | Role | What they receive |
|---|---|---|
| TREAT pilot study | Experimental | Metabolically unhealthy overweight or obese potential participants who pass an in-person screen will enroll in a 2-week run-in period when they will use the app, to assess meal patterns under habitual living conditions. Receives: Behavioral: TREAT pilot intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants logging
To measure the usage of app by recording the total number of days the participants logged in during study. Reported in percentage from 0 to 100% of time in use.
Measured: 3 months
Percentage of patients who reduced eating duration by 4 hours
Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
Measured: 3 months
Secondary outcomes (5)
% weight loss achieved post-intervention
Weight will be recorded and compared at baseline and 3 months.
Measured: Baseline to 3 months
Average time in duration of overnight fasting
Hours of overnight fasting will be recorded.
Measured: 3 months
Average time in sleep duration
Hours of sleep each night will be recorded.
Measured: 3 months
Adherence to using the app
Participants that completed daily food logs in app, and have days completed with correct eating duration.
Measured: 3 months
% of participants who achieve ≥ 5% weight loss
Weight will be recorded and compared at baseline and 3 months.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Jul 2019
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blandine Laferrere, Columbia University
- Investigators
- Blandine Laferrère, M.D., PhD., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956290
- Sponsor's protocol ID
- AAAS3053
- Status last verified
- Jul 2021
- First submitted
- 16 May 2019
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasad M, Fine K, Gee A, Nair N, Popp CJ, Cheng B, Manoogian ENC, Panda S, Laferrere B. A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Nutrients. 2021 Jun 23;13(7):2148. doi: 10.3390/nu13072148.
PubMed 34201442
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted EATing (TREAT) Pilot Study
- ClinicalTrials.gov ID
- NCT03956290
- Acronym / sponsor ID
- AAAS3053
- Conditions
- Overweight and Obesity, Pre Diabetes
- Keywords
- Time restricted eating, Overweight, Obesity, Metabolic syndrome, Diabetes treated with metformin and/or diet and HbA1C< 7%, Pre Diabetes, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 20 May 2019 (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.
The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.
Detailed description
Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.
Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREAT pilot study | Experimental | Behavioral: TREAT pilot interventionMetabolically unhealthy overweight or obese potential participants who pass an in-person screen will enroll in a 2-week run-in period when they will use the app, to assess meal patterns under habitual living conditions. |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age: 45-73y old
- overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
- pre-diabetes or diabetes only diet controlled (HbA1c <7%)
- elevated Blood Pressure (BP) 120-129/<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk <10%
- having LDL cholesterol <150mg/dl
Key exclusion criteria (14 listed)
- history or clinical evidence of condition that affect sleep
- significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
- history of seizure disorder
- being on medications for diabetes, hypertension or dyslipidemia
- previous bariatric surgery
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 |
|---|---|---|
| TREAT pilot interventionAlso: TREATParticipants will be asked to use the app and take pictures of everything they eat and drink, from the time they get up to the time they go to bed, regardless of size of meal/snacks/drink, for 2 weeks. This will generate data on their eating pattern and eating duration. Participants will be reminded through app, call or text by study staff based on personalized eating schedule. The sleep schedule will also be recorded. | Behavioural | TREAT pilot study |
Primary outcome
Percentage of participants logging
Time frame: 3 months
To measure the usage of app by recording the total number of days the participants logged in during study. Reported in percentage from 0 to 100% of time in use.
Percentage of patients who reduced eating duration by 4 hours
Time frame: 3 months
Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
5 secondary outcomes
% weight loss achieved post-intervention
Time frame: Baseline to 3 months
Average time in duration of overnight fasting
Time frame: 3 months
Average time in sleep duration
Time frame: 3 months
Adherence to using the app
Time frame: 3 months
% of participants who achieve ≥ 5% weight loss
Time frame: Baseline to 3 months
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 19 Jul 2021.
- Results publication: PubMed 34201442Prasad M, Fine K, Gee A, Nair N, Popp CJ, Cheng B, Manoogian ENC, Panda S, Laferrere B. A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Nutrients. 2021 Jun 23;13(7):2148. doi: 10.3390/nu13072148.
- Individual participant dataSharing planned: No
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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.
Blandine Laferrère, M.D., PhD. principal investigator
Columbia 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 TREAT pilot intervention in people with Overweight and Obesity and Pre Diabetes, run by Columbia 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 9 inclusion and 14 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 19 Jul 2021. 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?
Percentage of participants logging (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT03956290, which also lists 1 linked publication.
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 19 Jul 2021.