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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK117499-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful weight loss strategy. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators aims are to: 1) Assess processes critical for the success of a large-scale trial comparing the efficacy of a reduced calorie diet with time restricted feeding (RCD+TRF) versus standard RCD on weight loss; 2) Develop methodology to assess compliance to the RCD+TRF versus standard RCD program and collect preliminary data on whether the programs have differential effects on free-living behaviors (EI, appetite, physical activity, and sedentary behavior); and 3) Measure metabolic responses to RCD+TRF versus standard RCD to determine candidate mechanisms related to weight loss at 12wks and weight maintenance at 6mo post-intervention. The investigators primary hypothesis is that weight loss will be greater in the TRF group compared to the RCD group.
The circadian timing of energy intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating meals later in the evening or during the biological night when the circadian system is promoting sleep adversely influences the success of weight loss therapy. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful strategy for promoting weight loss and weight maintenance. However, potential benefits of adding TRF to a weight loss program have yet to be evaluated in a well-controlled clinical study. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators overall hypothesis is that feasibility, adherence, and acceptability of a weight loss intervention using TRF in the setting of a reduced calorie diet (RCD) - RCD+TRF - will be similar to compliance with an intervention using a reduced calorie diet alone (RCD), suggesting acceptability for a future large-scale trial. In this 12-week pilot and feasibility study, 30 overweight and obese individuals will be randomized 1:1 to RCD+TRF (EI restricted to a 10-hour window starting 1 hour from habitual waking time) or standard RCD (no restriction on feeding duration). Additional follow-up will occur at 6 months to collect pilot data on weight maintenance. Measures include feasibility, acceptability and adherence to the interventions, body weight, body composition (Dual-energy X-ray absorptiometry (DXA)), EI (smart phone application), physical activity (PA, accelerometery), glucose variability (continuous glucose monitoring, CGM), sleep (questionnaires and polysomnography), and nocturnal substrate metabolism (room calorimetry). The specific aims (SA) are as follows:
Specific Aim 1a. To evaluate the feasibility and acceptability of a 12-week TRF intervention compared to a standard dietary weight loss intervention (i.e. RCD). Feasibility of enrollment and retention, and acceptability of the intervention will be assessed in adults with obesity meeting inclusion/exclusion criteria proposed for the future large-scale trial. The investigators will assess adherence to the weight loss programs, as measured objectively with a novel smartphone application and verified with CGM data, and subjectively with the use of questionnaires.
Specific Aim 1b. To assess the efficacy of RCD+TRF compared to RCD alone in producing weight loss at 12 weeks and reducing the risk of weight regain after 6 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Calorie Diet (RCD) | Active Comparator | Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. |
|
| Time Restricted Feeding (TRF) | Experimental | Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Calorie Diet (RCD) | Behavioral | Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight | Body weight will be measured via clinic scale. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fat Mass | Body composition will be assessed with dual-energy x-ray absorptiometry (DXA). | Baseline, 12 weeks |
| Changes in Objectively Measured Energy Intake (Camera) | All energy intake events will be recorded using the camera function on a cell phone application |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Post-Intervention Follow-Up Body Weight | Body weight will be measured via clinic scale at 6 months post-intervention | 24 weeks after completion of the 12-week intervention (i.e. at week 36) |
| 6 Month Post-Intervention Follow-Up Fat Mass |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Thomas, MD | University of Colorado Anschutz Health and Wellness Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35470974 | Derived | Thomas EA, Zaman A, Sloggett KJ, Steinke S, Grau L, Catenacci VA, Cornier MA, Rynders CA. Early time-restricted eating compared with daily caloric restriction: A randomized trial in adults with obesity. Obesity (Silver Spring). 2022 May;30(5):1027-1038. doi: 10.1002/oby.23420. | |
| 35118814 | Derived | Zaman A, Sloggett KJ, Caldwell AE, Catenacci VA, Cornier MA, Grau L, Vetter C, Rynders CA, Thomas EA. The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention. Obesity (Silver Spring). 2022 May;30(5):1015-1026. doi: 10.1002/oby.23399. Epub 2022 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Calorie Diet (RCD) | Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. |
| FG001 | Time Restricted Feeding (TRF) | Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Calorie Diet (RCD) | Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Body Weight | Body weight will be measured via clinic scale. | Posted | Mean | Standard Deviation | kg | Baseline, 12 weeks |
|
39 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Calorie Diet (RCD) | Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. |
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This study was interrupted by the COVID-19 pandemic and the originally planned method for obtaining body weight at 12 weeks (DXA) could not be performed in the 3rd cohort of participants, so home scale weights were used instead.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Thomas, MD | University of Colorado School of Medicine | 303-724-9083 | elizabeth.thomas@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2020 | Apr 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Time Restricted Feeding (TRF) | Behavioral | Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows. |
|
| Baseline, 12 weeks |
| Changes in Physical Activity | Step count will be measured with activity monitors. | Baseline, 12 weeks |
| Changes in Sedentary Behavior | Sitting time will be measured with activity monitors. | Baseline, 12 weeks |
Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).
| 24 weeks after completion of the 12-week intervention (i.e. at week 36) |
| BG001 | Time Restricted Feeding (TRF) | Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Changes in Fat Mass | Body composition will be assessed with dual-energy x-ray absorptiometry (DXA). | Posted | Mean | Standard Deviation | kg | Baseline, 12 weeks |
|
|
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| Secondary | Changes in Objectively Measured Energy Intake (Camera) | All energy intake events will be recorded using the camera function on a cell phone application | Posted | Mean | Standard Deviation | kcal | Baseline, 12 weeks |
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| Secondary | Changes in Physical Activity | Step count will be measured with activity monitors. | Posted | Mean | Standard Deviation | steps/day | Baseline, 12 weeks |
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| Secondary | Changes in Sedentary Behavior | Sitting time will be measured with activity monitors. | Posted | Mean | Standard Deviation | minutes/day | Baseline, 12 weeks |
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| Other Pre-specified | 6 Month Post-Intervention Follow-Up Body Weight | Body weight will be measured via clinic scale at 6 months post-intervention | Posted | Mean | Standard Deviation | kg | 24 weeks after completion of the 12-week intervention (i.e. at week 36) |
|
|
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| Other Pre-specified | 6 Month Post-Intervention Follow-Up Fat Mass | Body composition will be assessed with dual-energy x-ray absorptiometry (DXA). | Posted | Mean | Standard Deviation | kg | 24 weeks after completion of the 12-week intervention (i.e. at week 36) |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Time Restricted Feeding (TRF) | Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows. | 0 | 41 | 0 | 41 | 0 | 41 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |