Daily Eating Patterns for Total Health Study (NCT06455995) | Clinical Trial Compass
RecruitingNot Applicable
Daily Eating Patterns for Total Health Study
United States174 participantsStarted 2024-07-16
Plain-language summary
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
Who can participate
Age range
25 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body mass index (BMI) between 27 and 45 kg/m2.
Exclusion Criteria:
* 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 being a shift workers/alternative shift workers that work outside of 7 am and 7 pm.
* 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 being unable to walk for 2 blocks (1/4 mile) without stopping.
* Report major psychiatric diseases or organic brain syndromes.
* 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.
* Report being pregnant, lactating, \< 6 months post-partum or plan to become pregnant (next 12 months).
* Report planning …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.