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Behavioural Intervention

Eating Patterns for Obesity (DEPTH Trial)

N/A

Recruiting

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how the timing of calorie intake throughout the day affects long-term weight loss over 12 months. Researchers want to understand if setting specific times to eat most calories in the morning or

Who is the study for?

This trial is for individuals with a BMI between 27 and 45 kg/m2 who are looking to lose weight. It's not suitable for those outside this BMI range.

What is being tested?

The DEPTH study tests if eating most calories in the morning or evening affects long-term weight loss. Participants follow a low-fat diet, exercise at least 200 minutes weekly, and receive behavioral therapy.

What are the potential side effects?

Potential side effects may include changes in appetite, sleep patterns, mood swings due to dietary restrictions, and physical strain from increased activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Mass Index (BMI)

Percent Weight Change

Secondary study objectives

Appetite regulation

Chronotype

Dietary intake

+3 more

Other study objectives

Process evaluation: Attendance

Process evaluation: Fidelity

Process evaluation: Self-monitoring of diet

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: DEPTH-MorningExperimental Treatment2 Interventions

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).

Group II: DEPTH-EveningExperimental Treatment2 Interventions

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).

Group III: DEPTH-StandardActive Control1 Intervention

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).

0 / 1Eligibility criteria met