Daily Eating Patterns for Total Health Study
Recruiting · NCT06455995 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Tennessee, Knoxville
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 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).
Where it is running
1 location listed across 1 US state.
- Healthy Eating and Activity Laboratory - Knoxville, Tennessee, United States