Daily Eating Patterns for Total Health Study

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age25-60

SponsorThe University of Tennessee, Knoxville

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) between 27 and 45 kg/m2.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).

Treatment groups

174 Participants

are divided into 3 treatment groups

Group A: DEPTH-StandardActive comparator 1 intervention

Group B: DEPTH-MorningExperimental treatment 2 interventions

Group C: DEPTH-EveningExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Percent Weight Change

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

Time frame

0, 3, 6, and 12 months

Body Mass Index (BMI)

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

Time frame

0, 3, 6, and 12 months

Secondary outcomes

Dietary intake

Dietary intake will be assessed by 3 (2 weekdays and 1 weekend day), random, 24-hr dietary phone recalls, using the five-step, multiple-pass method

Time frame

0, 3, 6, and 12 months

Sleep

Hours of daily sleep objectively measured by accelerometry

Time frame

0, 3, 6, and 12 months

Appetite regulation

Time- and semi-random sampling will be initiated via a smartphone tone, prompting participants to complete ratings (i.e. hunger, fullness, temptation to eat, desire to eat, and control over eating), using 100 mm visual analogue scales

Time frame

0, 3, 6, and 12 months

Waist circumference

Change in waist circumference in inches

Time frame

0, 3, 6, and 12 months

Other outcomes

Process evaluation: Self-monitoring of diet

Achievement of condition specific diet goals (adherence) will be documented (days/wk for overall energy and fat goal \[staying with + 5% of each goal\]; first eating occasion \< 60 minutes of awakening; daily eating window length \< 12 hours; four eating occasions per day; and time-based energy intake goals \[staying within + 5% of each goal\] for Morning and Evening only)

Time frame

Throughout the 12-month intervention

Process evaluation: Self-monitoring of physical activity

From physical activity self-monitoring records, number of weeks minutes that MVPA is within + 5% of the goal will be documented.

Time frame

Throughout the 12-month intervention

Process evaluation: Attendance

Number of sessions attended will be recorded

Time frame

Throughout the 12-month intervention

Process evaluation: Fidelity

All sessions will be audiotaped and the PI will review 33% of these sessions for treatment fidelity

Time frame

Throughout the 12-month intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Tennessee, Knoxville

Lead sponsor

Source ClinicalTrials.gov

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