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A randomized controlled trial to determine adherence, acceptability and safety of time restricted eating (TRE) in healthy, sedentary, free-living adults with obesity between the ages of 19-65 years when following 16:8 TRE for 8 weeks. This 9-week study includes a baseline week and 8 weeks of the intervention period. Participants are randomly assigned to the TRE or the non-fasting control group. The TRE group will consume calorie containing food and drink only over an 8 hour period and rest of the 16 hour would be fasting. Adherence to TRE and calorie intake are the primary outcomes. Motivators, facilitators and barriers to TRE, hunger and cravings levels, weight bias internalization, body composition (weight, body fat%, fat mass and muscle mass) , Healthy Eating Index (HEI) to assess diet quality, skin carotenoid levels, disordered eating risk, sleep quality, and perceptions of health and well-being are secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Eating Group | Experimental | The TRE group will consume calorie-containing food and drinks only over an 8-hour window between 6 a.m. to 8 p.m. for 8 weeks. During the fasting period, they can take only calorie-free fluids. |
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| Control | No Intervention | They will follow their usual eating patterns and consume food over a period of 12 hours or more. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Eating | Behavioral | The intervention group will eat and drink in a prescribed daily feeding window of 8-hour between 6 a.m. to 8 p.m. for 8 weeks and follow their normal exercise and resistance training routines. We will allow +/-1 hour starting and ending times for the eating window while aiming for an 8-hour eating window |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Percent of days during the 8-week trial when TRE was adhered to as recommended. This will be self-reported daily. | 8 weeks |
| Total calorie intake | Pre and post intervention measurements of calorie intake based on three 24-hour food recall surveys using the NDSR software. | During baseline week and week 8 of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Pre and post intervention measures of body weight. | At baseline and at the end of 8 weeks of intervention |
| 24-hour physical activity energy expenditure (PAEE) | GT9X Actigraph accelerometer will be used over 7 days to measure physical activity energy expenditure pre-intervention and during week 8 of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN | Contact | 662 915 1351 | nadeejaw@olemiss.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Hospitality Management, University of Mississippi | Recruiting | Oxford | Mississippi | 38677 | United States |
We will share the de-identified participant data used in the published manuscripts by depositing these data in a secure data repository. The data shared will include the sociodemographic data and the outcomes published in the manuscripts. The protocol and statistical analysis plan will be shared as supplementary material through the journal where the study if published, if allowed
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 |
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| During baseline week and week 8 of the intervention |
| Body fat percentage (%) | Pre and post intervention measurements of body fat percentage measured by bioelectrical impedance analyzer. | At baseline and at the end of 8 weeks of intervention |
| Fat-free mass (kg) | Pre and post intervention measurements of body fat-free mass (kg) measured by bioelectrical impedance analyzer. | At baseline and at the end of 8 weeks of intervention |
| Fat mass (kg) | Pre and post intervention measurements of body fat mass (kg) measured by bioelectrical impedance analyzer. | At baseline and at the end of 8 weeks of intervention |
| Hunger and satiety | Pre and post intervention subjective measure of hunger and satiety with the use of a Hunger and Satiety Visual Analog Scale | During baseline week and week 8 of the intervention |
| Sleep quality | Pre and post intervention measure of subjective sleep quality by use of Pittsburgh Sleep Quality Scale. | One time during the baseline week and week 8 of the intervention |
| Diet Quality | Pre and post intervention measurements of diet quality based on three 24-hour food recall surveys at pre- and post collected using the NDSR software and Healthy Eating Index was calculated. | During baseline week and week 8 of the intervention |
| Perceptions of health and well-being | Pre- and post quality of life will be assessed using RAND 36-Item Health Survey 1.0 (SF-36) | At baseline and at the end of 8 weeks of intervention |
| Weight Bias Internalization | Pre- and post weight bias internalization will be assessed using the Weight Bias Internalization Scale (WBIS). | At baseline and at the end of 8 weeks of intervention |
| Disordered eating risk | Pre- and post disordered eating risk will be assessed using Eating Attitude Test (EAT-26) survey scores | At baseline and at the end of 8 weeks of intervention |
| Eating Behavior | Pre and post eating behavior will be assessed using the Three Factor Eating Questionnaire (TFEQ-18). The TFEQ-R18 measures 3 aspects of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating | At baseline and at the end of 8 weeks of intervention |
| Skin carotenoid | Pre- and post skin carotenoid levels will be measured pre and post-intervention using a non-invasive NuSkin Biophotonic scanner which is based on the Resonant Raman Spectroscopy technology. | At baseline and at the end of 8 weeks of intervention |
| Motivators, barriers, and facilitators for following time restricted eating | Motivators, barriers, and facilitators when following time restricted eating will be assessed only in the TRE group. These will be collected as qualitative data in the format of a semi-structured interviews over Zoom. | At end of 2nd week and during the 8th week of intervention. |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |