Clinical trial

Daily Eating Patterns for Total Health Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT06455995

Recruiting nowNot applicableInterventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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).

Treatments and study arms

DEPTH

Behavioral

All conditions will receive a reduced-energy, low-fat dietary prescription (1200-1500 kcal/d, \< 30% energy from fat), physical activity goals (\> 200 min/wk of moderate- to vigorous-intensity physical activity \[MVPA\]) and a cognitive behavioral intervention. To minimize the effect of other eating temporal variables on outcomes, guidance on the eating window length and the number of eating occasions in the day will be consistent across all three conditions. Thus, the three conditions will be instructed to have their first eating occasion \< 60 minutes of awakening, and eat their three meals and one snack within a 12-hr eating window.

DEPTH-Morning

Behavioral

Morning will also have time-based energy intake goals of 70% of kcal within the first 6 hrs of the eating window and 30% of kcal within the last 6 hrs of the eating window (a morning-loaded energy distribution).

DEPTH-Evening

Behavioral

Evening will also have time-based energy intake goals of 30% of kcal within the first 6 hrs of the eating window and 70% of kcal within the last 6 hrs of the eating window (an evening-loaded energy distribution).

Primary outcomes

Percent Weight Change0, 3, 6, and 12 months

Percent change in weight (weight change in lbs at follow up / baseline weight in lbs)

Body Mass Index (BMI)0, 3, 6, and 12 months

Change in BMI calculated as weight in kg / height in m2

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Healthy Eating and Activity Laboratory🇺🇸 Knoxville, Tennessee, United States

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