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| ID | Type | Description | Link |
|---|---|---|---|
| K99HL163474 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-Restricted Eating - 6 Hours (TRE6) | Experimental | Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period. |
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| Time-Restricted Eating - 10 Hours (TRE10) | Experimental | Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating (TRE) | Behavioral | TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | Percentage of participants who complete all study visits. Measure of feasibility. | Up to Week 12 |
| Recruitment Rate | Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight. | Up to Week 12 |
| TRE Experience Questionnaire (TRE-EQ) Score | Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners). | Week 12 |
| Adherence Rate | Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled "adherent" if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Lean Mass | Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms. | Baseline, Week 12 |
| Change from Baseline in Fat Mass | Measured using BIA. Expressed in kilograms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary A. Sevick, ScD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [collin.popp@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to collin.popp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 17, 2026 | |
| Reset | Mar 6, 2026 | |
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 | |
| Release | Apr 14, 2026 | |
| Reset | May 4, 2026 | |
| Release | May 6, 2026 | |
| Reset | Jun 1, 2026 | |
| Release | Jun 4, 2026 | |
| Reset | Jun 29, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2024 | Jan 14, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 17, 2026 | Mar 6, 2026 | |||
| Mar 25, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline, Week 12 |
| Apr 13, 2026 |
| Apr 14, 2026 | May 4, 2026 |
| May 6, 2026 | Jun 1, 2026 |
| Jun 4, 2026 | Jun 29, 2026 |
| Jul 6, 2026 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |