CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 95 enrolled
Drug / intervention
Reduced Calorie Diet (RCD) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03571048
NCT03571048N/ACompleted

Pilot Study of Time Restricted Feeding as a Weight Loss Intervention in Overweight and Obese Adults

University of Colorado, Denver·interventional·Posted Jun 27, 2018·Updated Oct 25, 2022

In Brief

A clinical study evaluating Reduced Calorie Diet (RCD) and Time Restricted Feeding (TRF) for Obesity. Completed, enrolled 95 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartJun 1, 2018
Primary CompletionMay 14, 2020
Study CompletionNov 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.0 years ago

Interventions

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.

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.