Daily Eating Patterns for Total Health Study

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
The University of Tennessee, Knoxville
Study ID
NCT06455995
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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

Key Dates

Start date
Jul 16, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DEPTH-Standard
    Participants in the Standard Group 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. Standard group will receive no guidance on energy intake distribution (standard lifestyle intervention).
  • Experimental: DEPTH-Morning
    Participants in the Morning Group 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. They 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).
  • Experimental: DEPTH-Evening
    Participants in the Evening Group 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. They 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 Outcome Measure

Percent Weight Change [ Time Frame: 0, 3, 6, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Healthy Eating and Activity LaboratoryKnoxvilleTennessee37996-

Find similar trials in Knoxville, TN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Healthy Eating and Activity Laboratory· Knoxville, TN

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