RECRUITING

Daily Eating Patterns for Total Health Study

Conditions

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

The goal of this randomized controlled trial is to learn how the time of day when calories are eaten affects weight loss in the long-term (12 months). The main aims are to learn: 1. The influence of time-based energy intake goals on longer-term weight loss. 2. The influence of time-based energy intake goals on eating temporal patterns, sleep regularity, and appetite regulation. Researchers will compare whether goals to eat most of a person's calories in the morning or evening work to treat obesity. Participants will: 1. Eat a reduced-calorie, low-fat diet (some participants will have goals to eat their calories at certain times of day based on their group) 2. Be physically active at least 200 minutes 3. Receive a cognitive behavioral intervention

Official Title

Effect of Time-based Energy Intake Goals on Weight Loss During Obesity Treatment

Quick Facts

Study Start:2024-07-16
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455995

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:25 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) between 27 and 45 kg/m2.
  1. * Report not regularly (\>/= 5 days/wk) consuming energy (\>/= 100 kcal) prior to 12 pm, and not being able to consume energy every day (\>/= 50 kcal) within one hour of awakening.
  2. * Report taking sleep medication or not regularly (\>/= 5 nights/wk) getting at least 6 hrs of total sleep.
  3. * Report being a shift workers/alternative shift workers that work outside of 7 am and 7 pm.
  4. * Report being diagnosed with type 1, or type 2 diabetes and taking medication that requires eating to occur at certain time periods.
  5. * Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  6. * Report being unable to walk for 2 blocks (1/4 mile) without stopping.
  7. * Report major psychiatric diseases or organic brain syndromes.
  8. * Report currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost \>/= 5% of body weight during the past 6 months.
  9. * Report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 12 months.
  10. * Report being pregnant, lactating, \< 6 months post-partum or plan to become pregnant (next 12 months).
  11. * Report planning to move outside of the metropolitan area within the time frame of the investigation.
  12. * Do not have daily access to PC with internet or smartphones (needed for self-monitoring).

Contacts and Locations

Study Contact

Hollie A Raynor, PhD
CONTACT
865-974-9126
hraynor@utk.edu

Study Locations (Sites)

Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
United States

Collaborators and Investigators

Sponsor: The University of Tennessee, Knoxville

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 Date2024-07-16
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-07-16
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity