NCT06455995Recruiting
Daily Eating Patterns for Total Health Study
Effect of Time-based Energy Intake Goals on Weight Loss During Obesity Treatment
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- 16 Jul 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- The University of Tennessee, Knoxville
- Diseases
- Obesity
- NCT number
- NCT06455995
What you commit to
- Study type: Interventional
- Planned participants: 174
- From 16 Jul 2024 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Report taking sleep medication or not regularly (\>/= 5 nights/wk) getting at least 6 hrs of total sleep.
- 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.
- Report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 12 months.
Other illness
- Report being diagnosed with type 1, or type 2 diabetes and taking medication that requires eating to occur at certain time periods.
- 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.
- Report major psychiatric diseases or organic brain syndromes.
Other
- Report being a shift workers/alternative shift workers that work outside of 7 am and 7 pm.
- Report being unable to walk for 2 blocks (1/4 mile) without stopping.
- Report being pregnant, lactating, \< 6 months post-partum or plan to become pregnant (next 12 months).
- Report planning to move outside of the metropolitan area within the time frame of the investigation.
- Do not have daily access to PC with internet or smartphones (needed for self-monitoring).
Who the study is looking for
- Body mass index (BMI) between 27 and 45 kg/m2.
Age in the registry: 25 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healthy Eating and Activity Laboratory Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.