Pilot Study of Time Restricted Feeding as a Weight Loss Intervention
2 other identifiers
interventional
95
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2018
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedResults Posted
Study results publicly available
October 25, 2022
CompletedOctober 25, 2022
October 1, 2022
2 years
May 31, 2018
April 15, 2022
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Body Weight
Body weight will be measured via clinic scale.
Baseline, 12 weeks
Secondary Outcomes (4)
Changes in Fat Mass
Baseline, 12 weeks
Changes in Objectively Measured Energy Intake (Camera)
Baseline, 12 weeks
Changes in Physical Activity
Baseline, 12 weeks
Changes in Sedentary Behavior
Baseline, 12 weeks
Other Outcomes (2)
6 Month Post-Intervention Follow-Up Body Weight
24 weeks after completion of the 12-week intervention (i.e. at week 36)
6 Month Post-Intervention Follow-Up Fat Mass
24 weeks after completion of the 12-week intervention (i.e. at week 36)
Study Arms (2)
Reduced Calorie Diet (RCD)
ACTIVE COMPARATORParticipants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Time Restricted Feeding (TRF)
EXPERIMENTALParticipants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Adult males and females with a BMI of 27-45 kg/m2 and weight stable over the previous 6 months;
- Age, 18-50 years old;
- Passing medical and physical screening, and analysis of blood and urine screening samples;
- Typical eating duration \>12 hours per day (assessed by questionnaires);
- Own a smartphone
You may not qualify if:
- Pregnancy or lactation for women (women who are \>6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months)
- Postmenopausal women (menopausal status will be assessed during the history and physical, with requirement of self-reported regular menstrual cycles for the last year; women who have undergone hysterectomy but with ovaries in place who continue to have regular menstrual symptoms can be included)
- Being considered unsafe to participate as determined by the study physician;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- History of human immunodeficiency virus or hepatitis B or C (self-report);
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- Having abnormal blood chemistry (eGFR\<45mL/min, AST or ALT \>3 times the upper limit of normal) or as deemed significant by the study physician;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- Working night shifts;
- Extreme early or extreme late chronotype as determined by the Munich Chronotype questionnaire37;
- Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week) as assessed with meal pattern assessment questionnaire;
- For participants completing the PSG studies, greater than moderate sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire). Participants completing the primary weight loss intervention will not be excluded based on Berlin OSA risk scores.
- For participants completing the PSG studies, use of medications affecting sleep (benzodiazepines and other sleep aids, as determined by study physician). Participants completing the primary weight loss intervention will not be excluded based on use of medications affecting sleep.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80045, United States
Related Publications (2)
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.
PMID: 35470974DERIVEDZaman 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.
PMID: 35118814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Elizabeth Thomas, MD
- Organization
- University of Colorado School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Thomas, MD
University of Colorado Anschutz Health and Wellness Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2018
First Posted
June 27, 2018
Study Start
June 1, 2018
Primary Completion
May 14, 2020
Study Completion
November 12, 2020
Last Updated
October 25, 2022
Results First Posted
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share