Overweight and ObesityNY-TREATNCT04465721
TREAT to Improve Cardiometabolic Health
A study testing TRE and HABIT in people with Overweight and Obesity and Prediabetes, run by Columbia University at 1 site in United States.
Trial summary
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Overweight and Obesity, Prediabetes
- What is being tested?
- TRE and HABIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 1 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 50-75y old
- BMI ≥25 and ≤45 kg/m2
- a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:
- diagnosis of hypertension on stable medication regimen
- blood pressure >120/>80 mmHg
- A diagnosis of dyslipidemia on stable regimen
Show all 16Show fewer
- triglycerides 150 mg/dL
- HDL cholesterol men <40 mg/dL and women <50 mg/dL
- waist circumference men: >102 cm (>40 in); women >88 cm (>35 in)
- in possession of a smart phone (iPhone or Android)
- 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
- Sleep duration 6-h, with habitual self-reported wake up time >5AM and before 11 AM and average self reported bed time <2AM
- habitually eat breakfast
- with weight stability within 5% of screening for the last 3 months
- English speaking (the App has not yet been translated)
- must live in the New York City metro area
Who cannot join
- sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index >30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
- significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
- history of seizure disorder
- previous bariatric surgery or on weight loss medication
- history of or current significant food intake or psychiatric disorder
- use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
Show all 13Show fewer
- smoking tobacco or using illegal or recreational drugs
- consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk)
- anemia (hemoglobin <10 g/dl and hematocrit <30%)
- have conditions that render individual unable to complete all testing procedures [e.g., unable to stay overnight or frequent travel across 1 time zones]
- extreme early and late chronotypes (> 2AM bed time and wake up time before 5AM and > 11AM)
- severe food allergies
- unwilling/unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New York TREAT (Time Restricted EATing) to Improve Cardiometabolic Health Study
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.
Read the detailed description
American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decrease cardiovascular risk, yet adherence to long term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to implement and sustain, and affordable life style interventions. Restricting the food intake interval, or time restricted eating (TRE) has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than calorie count. We propose to rigorously assess the efficacy and sustainability of self-monitoring with and without TRE, administered via a smartphone application, on weight loss and decreased cardiovascular risk. To achieve this goal, metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a self monitoring and restricted eating window to 10h/d (TRE) or to a self-monitoring and habitual eating window (13h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and outpatient well controlled studies will be done to determine the effect of TRE versus habitual eating duration (HABIT), as well as the mediators of these effects. Hypotheses: 1) TRE vs. HABIT will result in decreased fat mass, measured by quantitative magnetic resonance, and effect mediated via decreased daily total energy intake, measured by double labeled water; 2) TRE vs. HABIT will result in lower insulin resistance, lower glycemia and shift in fuel utilization preferentially to lipid mobilization; 3) Adherence to the TRE intervention will be associated with greater weight loss at 3 months and weight maintenance at 12 months. Results from this study will provide important insights into understanding the physiological and molecular interactions between restricting daily eating interval and metabolic function, and could provide evidence for using TRE interventions to improve metabolic health and decrease cardiovascular risk in the large number of mid-life and older Americans in great need of life style intervention.
- Conditions
- Overweight and Obesity, Prediabetes
- Being tested
- TRE, HABIT
- Keywords
- Overweight, Obesity, Metabolic syndrome, Time restricted eating, Diabetes, Prediabetes, Lifestyle intervention, Smartphone app
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Metabolic Syndrome, Intermittent Fasting, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREBehavioural
The TRE intervention will be administered and monitored via the study app. It combines self-monitoring behavior, daily eating window reminders, positive reinforcement based on number of log entries or based on meeting eating widow target, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring, and to reducing the eating window.
HABITBehavioural
The HABIT intervention will be administered and monitored via the study app. It combines self-monitoring behavior, positive reinforcement based on number of log entries, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring.
| Study group | Role | What they receive |
|---|---|---|
| HABIT Group | Active comparator | Participants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h). Receives: Behavioral: HABIT |
| TRE Group | Experimental | Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h). Receives: Behavioral: TRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 0 and day 13 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.
Measured: 0, 3, and 12 months
Energy intake
Energy intake (EI) will be calculated from total daily energy expenditure (EE) measured by doubly labeled water (DLW), and changes in body energy stores (ΔES), measured by QMR over the 2-wk ambulatory assessments of the 0 and 3 month study periods: EI (kcal/d) = EEDLW + ΔES.
Measured: 0, 3 months
Body weight
Changes in body weight (kg) will be measured to the nearest 0.01 kg with a digital scale at 0 and 3 months, and again at 12 months.
Measured: 0, 3, 12 months
Insulin resistance (HOMA-IR)
Fasting serum insulin and plasma glucose concentrations will be used to calculate changes in insulin resistance (HOMA-IR): [fasting insulin (mU/mL) x fasting glucose (mmol/L)]/22.5 at 0 and 3 months, and again at 12 months.
Measured: 0, 3, 12 months
Glucose levels
Glucose changes will be assessed by the total and incremental 24-hour glucose AUC, from ambulatory CGM at 0 and 3 months.
Measured: 0, 3,12 months
Glucose variability
CGM data will be used to calculate standard measures of glucose variability (GV), including mean amplitude of glycemic excursion (MAGE) changes at 0 and 3 months.
Measured: 0, 3,12 months
Sleep assessment
Sleep duration will be assessed by changes in bedtime, waketime, and total sleep time, recorded by actigraphy during the 2-wk ambulatory assessments at 0, 3, and 12 months.
Measured: 0, 3,12 months
Adherence
Adherence will be assessed by % of days with at least 2 or more entries logged at least 5h apart/day
Measured: 0, 3,12 months
Secondary outcomes (9)
Diet composition by ASA24
% of carbs, fat and protein in diet by ASA24 on 3 non-consecutive days (2 weekdays and one weekend day) during each ambulatory assessment and during the 3 months intervention.
Measured: 0, 3, 12 months
Matsuda Index (Insulin resistance)
Fasting and OGTT glucose and insulin levels are used to calculate the Matsuda index:
10,000/([fasting insulin (mU/mL)x fasting glucose (mmol/L)]x [mean OGTT insulin (mU/mL) x mean OGTT glucose (mmol/L)])
Measured: 0, 3 months
Insulinogenic Index
Calculated by the AUC insulin/AUC glucose during OGTT.
Measured: 0, 3 months
Free fatty acids (FFA)
Measured from a fasting blood sample
Measured: 0, 3, 12 months
Ketones
The concentration of ketones (beta-OH-butyrate) will be measured from a fasting blood sample.
Measured: 0, 3, 12 months
Physical activity
Assessed by step count during 14 day ambulatory assessment periods at 0,3, and 12 months.
Measured: 0, 3, 12 months
Inflammation markers
Measured from a fasting blood sample.
Measured: 0, 3, 12 months
Oxidative stress
Measured from a fasting blood sample
Measured: 0, 3, 12 months
Lipid profile
Measured from a fasting blood sample
Measured: 0, 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start14 Jun 2021
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a restricted eating window to 10h/d (TRE group) or to their habitual eating window (≥ 13h, HABIT group), and followed up to 12 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Salk Institute for Biological Studies, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Blandine Laferrere, Columbia University
- Investigators
- Blandine Laferrère, M.D., Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465721
- Sponsor's protocol ID
- AAAS7791
- Other IDs
- R01AG065569
- Acronym
- NY-TREAT
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Columbia University is committed to the open and timely dissemination of research outcomes. Investigators in this proposed project are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." All data used in this proposal will de-identified, and accessed using a secure data area using a shared drive, protected by password only to be accessed by those directly involved in the clinical research. All transfer of data will use encrypted methods. Wherever applicable, fully de-identified data will be deposited to appropriate public repositories, following the Federal Health Insurance Privacy and Portability Act (HIPAA).
Publications
Santos-Baez LS, Kazmi O, Diaz-Rizzolo D, Popp CJ, Manoogian ENC, Panda S, Cheng B, Laferrere B. Comparison of Self-Reported Dietary Recalls and Real-Time Tools to Track Mealtimes in Older Adults: A Pilot Study. Inquiry. 2026 Jan-Dec;63:469580261419162. doi: 10.1177/00469580261419162. Epub 2026 Feb 18.
PubMed 41709100Santos-Baez LS, Ravelli MN, Diaz-Rizzolo DA, Popp CJ, Gallagher D, Cheng B, Schoeller D, Laferrere B. Dietary misreporting: a comparative study of recalls vs energy expenditure and energy intake by doubly-labeled water in older adults with overweight or obesity. BMC Med Res Methodol. 2025 Apr 26;25(1):115. doi: 10.1186/s12874-025-02568-4.
PubMed 40287632Diaz-Rizzolo DA, Santos Baez LS, Popp CJ, Borhan R, Sordi-Guth A, Manoogian ENC, Panda S, Cheng B, Laferrere B. Late eating is associated with poor glucose tolerance, independent of body weight, fat mass, energy intake and diet composition in prediabetes or early onset type 2 diabetes. Nutr Diabetes. 2024 Oct 25;14(1):90. doi: 10.1038/s41387-024-00347-6.
PubMed 39455572Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Santos-Baez LS, Garbarini A, Shaw D, Cheng B, Popp CJ, Manoogian ENC, Panda S, Laferrere B. Time-restricted eating to improve cardiometabolic health: The New York Time-Restricted EATing randomized clinical trial - Protocol overview. Contemp Clin Trials. 2022 Sep;120:106872. doi: 10.1016/j.cct.2022.106872. Epub 2022 Aug 4.
PubMed 35934281
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New York TREAT (Time Restricted EATing) to Improve Cardiometabolic Health Study
- ClinicalTrials.gov ID
- NCT04465721
- Acronym / sponsor ID
- NY-TREAT / AAAS7791
- Conditions
- Overweight and Obesity, Prediabetes
- Keywords
- Overweight, Obesity, Metabolic syndrome, Time restricted eating, Diabetes, Prediabetes, Lifestyle intervention, Smartphone app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York University, Salk Institute for Biological Studies, National Institute on Aging (NIA)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Jul 2020 (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.
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.
Detailed description
American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decrease cardiovascular risk, yet adherence to long term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to implement and sustain, and affordable life style interventions. Restricting the food intake interval, or time restricted eating (TRE) has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than calorie count. We propose to rigorously assess the efficacy and sustainability of self-monitoring with and without TRE, administered via a smartphone application, on weight loss and decreased cardiovascular risk. To achieve this goal, metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a self monitoring and restricted eating window to 10h/d (TRE) or to a self-monitoring and habitual eating window (13h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and outpatient well controlled studies will be done to determine the effect of TRE versus habitual eating duration (HABIT), as well as the mediators of these effects. Hypotheses: 1) TRE vs. HABIT will result in decreased fat mass, measured by quantitative magnetic resonance, and effect mediated via decreased daily total energy intake, measured by double labeled water; 2) TRE vs. HABIT will result in lower insulin resistance, lower glycemia and shift in fuel utilization preferentially to lipid mobilization; 3) Adherence to the TRE intervention will be associated with greater weight loss at 3 months and weight maintenance at 12 months. Results from this study will provide important insights into understanding the physiological and molecular interactions between restricting daily eating interval and metabolic function, and could provide evidence for using TRE interventions to improve metabolic health and decrease cardiovascular risk in the large number of mid-life and older Americans in great need of life style intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a restricted eating window to 10h/d (TRE group) or to their habitual eating window (≥ 13h, HABIT group), and followed up to 12 months.
| Arm | Type | Receives |
|---|---|---|
| HABIT Group | Active comparator | Behavioral: HABITParticipants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h). |
| TRE Group | Experimental | Behavioral: TREParticipants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- age: 50-75y old
- BMI ≥25 and ≤45 kg/m2
- a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:
- in possession of a smart phone (iPhone or Android)
- 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
Key exclusion criteria (13 listed)
- sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index >30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
- significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
- history of seizure disorder
- previous bariatric surgery or on weight loss medication
- history of or current significant food intake or psychiatric disorder
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 |
|---|---|---|
| TREThe TRE intervention will be administered and monitored via the study app. It combines self-monitoring behavior, daily eating window reminders, positive reinforcement based on number of log entries or based on meeting eating widow target, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring, and to reducing the eating window. | Behavioural | TRE Group |
| HABITThe HABIT intervention will be administered and monitored via the study app. It combines self-monitoring behavior, positive reinforcement based on number of log entries, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring. | Behavioural | HABIT Group |
Primary outcome
Fat mass
Time frame: 0, 3, and 12 months
Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 0 and day 13 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.
Energy intake
Time frame: 0, 3 months
Energy intake (EI) will be calculated from total daily energy expenditure (EE) measured by doubly labeled water (DLW), and changes in body energy stores (ΔES), measured by QMR over the 2-wk ambulatory assessments of the 0 and 3 month study periods: EI (kcal/d) = EEDLW + ΔES.
Body weight
Time frame: 0, 3, 12 months
Changes in body weight (kg) will be measured to the nearest 0.01 kg with a digital scale at 0 and 3 months, and again at 12 months.
Insulin resistance (HOMA-IR)
Time frame: 0, 3, 12 months
Fasting serum insulin and plasma glucose concentrations will be used to calculate changes in insulin resistance (HOMA-IR): [fasting insulin (mU/mL) x fasting glucose (mmol/L)]/22.5 at 0 and 3 months, and again at 12 months.
Glucose levels
Time frame: 0, 3,12 months
Glucose changes will be assessed by the total and incremental 24-hour glucose AUC, from ambulatory CGM at 0 and 3 months.
Glucose variability
Time frame: 0, 3,12 months
CGM data will be used to calculate standard measures of glucose variability (GV), including mean amplitude of glycemic excursion (MAGE) changes at 0 and 3 months.
Sleep assessment
Time frame: 0, 3,12 months
Sleep duration will be assessed by changes in bedtime, waketime, and total sleep time, recorded by actigraphy during the 2-wk ambulatory assessments at 0, 3, and 12 months.
Adherence
Time frame: 0, 3,12 months
Adherence will be assessed by % of days with at least 2 or more entries logged at least 5h apart/day
9 secondary outcomes
Diet composition by ASA24
Time frame: 0, 3, 12 months
Matsuda Index (Insulin resistance)
Time frame: 0, 3 months
Insulinogenic Index
Time frame: 0, 3 months
Free fatty acids (FFA)
Time frame: 0, 3, 12 months
Ketones
Time frame: 0, 3, 12 months
Physical activity
Time frame: 0, 3, 12 months
Inflammation markers
Time frame: 0, 3, 12 months
Oxidative stress
Time frame: 0, 3, 12 months
Lipid profile
Time frame: 0, 3, 12 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 2 Nov 2026.
- Derived from this study: PubMed 41709100Santos-Baez LS, Kazmi O, Diaz-Rizzolo D, Popp CJ, Manoogian ENC, Panda S, Cheng B, Laferrere B. Comparison of Self-Reported Dietary Recalls and Real-Time Tools to Track Mealtimes in Older Adults: A Pilot Study. Inquiry. 2026 Jan-Dec;63:469580261419162. doi: 10.1177/00469580261419162. Epub 2026 Feb 18.
- Derived from this study: PubMed 40287632Santos-Baez LS, Ravelli MN, Diaz-Rizzolo DA, Popp CJ, Gallagher D, Cheng B, Schoeller D, Laferrere B. Dietary misreporting: a comparative study of recalls vs energy expenditure and energy intake by doubly-labeled water in older adults with overweight or obesity. BMC Med Res Methodol. 2025 Apr 26;25(1):115. doi: 10.1186/s12874-025-02568-4.
- Derived from this study: PubMed 39455572Diaz-Rizzolo DA, Santos Baez LS, Popp CJ, Borhan R, Sordi-Guth A, Manoogian ENC, Panda S, Cheng B, Laferrere B. Late eating is associated with poor glucose tolerance, independent of body weight, fat mass, energy intake and diet composition in prediabetes or early onset type 2 diabetes. Nutr Diabetes. 2024 Oct 25;14(1):90. doi: 10.1038/s41387-024-00347-6.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 35934281Santos-Baez LS, Garbarini A, Shaw D, Cheng B, Popp CJ, Manoogian ENC, Panda S, Laferrere B. Time-restricted eating to improve cardiometabolic health: The New York Time-Restricted EATing randomized clinical trial - Protocol overview. Contemp Clin Trials. 2022 Sep;120:106872. doi: 10.1016/j.cct.2022.106872. Epub 2022 Aug 4.
- Individual participant dataSharing planned: Yes. Columbia University is committed to the open and timely dissemination of research outcomes. Investigators in this proposed project are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." All data used in this proposal will de-identified, and accessed using a secure data area using a shared drive, protected by password only to be accessed by those directly involved in the clinical research. All transfer of data will use encrypted methods. Wherever applicable, fully de-identified data will be deposited to appropriate public repositories, following the Federal Health Insurance Privacy and Portability Act (HIPAA).
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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., Ph.D. 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 TRE and HABIT in people with Overweight and Obesity and Prediabetes, 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 16 inclusion and 13 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 2 Nov 2026. 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?
Fat mass (time frame: 0, 3, and 12 months). The study lists 8 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 NCT04465721, which also lists 5 linked publications.
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 2 Nov 2026.