RECRUITING

Time-restricted Eating Acceptability, Efficacy and Safety in Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time-restricted Eating Acceptability, Efficacy and Safety in Free-living Adults With Obesity

Quick Facts

Study Start:2024-06-01
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06695988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 19 to 65 years
  2. * Owns a smartphone
  3. * Apparently healthy
  4. * BMI ( more than or equal to 25 kg/m2 ) and high body fat percent (BF%) (≥25% and ≥35% for males and females, respectively)
  5. * Sedentary lifestyle (less than 150 minutes of self-reported moderate to vigorous activity per week)
  6. * Self-reported eating interval of ≥12 h per day
  1. * Diagnosed diabetes mellitus (type I or II), coronary heart disease, heart failure, hypertension, hyperlipidemia, stroke, chronic lung diseases, liver or kidney disease, adrenal diseases, musculoskeletal disorders, uncontrolled thyroid disease (dose changes within the past 3 months), Crohn's disease, Ulcerative Colitis, arthritis, undergoing active cancer treatment except for non-melanoma cancer, uncontrolled psychiatric disorder (a history of hospitalization for psychiatric illness).
  2. * Currently taking any medication that is meant for, or has a known effect on, appetite
  3. * On anabolic steroid or hormone replacement therapy
  4. * Participation in an exercise/nutrition/ weight-loss program within the last 6 months
  5. * Any history of surgical intervention for weight management
  6. * Having a ≥5% body weight change during the last 3 months
  7. * Pregnant or less than 6 months post-partum, breastfeeding, polycystic ovarian syndrome or irregular menstruation
  8. * missing limbs, have a pacemaker or metal implants,
  9. * eating disorders or EAT-26 score \>20
  10. * Alcohol or drug addiction
  11. * Current smoker
  12. * Works night shifts
  13. * Unable to commit to a 9-week study
  14. * Not willing to follow study protocol and any other contraindications.
  15. * Currently following any of the following restrictive diets - Keto/low carbohydrate/ Vegan/ Vegetarian/ Intermittent fasting/ Paleo/ Calorie restriction/ Any other restrictive diet
  16. * Participating in another study

Contacts and Locations

Study Contact

Nadeeja N Wijayatunga, MBBS, MPhil, PhD, RDN
CONTACT
662 915 1351
nadeejaw@olemiss.edu

Study Locations (Sites)

Department of Nutrition and Hospitality Management, University of Mississippi
Oxford, Mississippi, 38677
United States

Collaborators and Investigators

Sponsor: University of Mississippi, Oxford

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

  • Time Restricted Eating
  • Obesity
  • Intervention
  • 9 weeks
  • Randomization
  • Intermittent fasting

Additional Relevant MeSH Terms

  • Time Restricted Eating