Eating Patterns for Obesity

(DEPTH Trial)

Overseen By Hollie A Raynor, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Sleep medications, Weight loss medications

Disqualifiers: Diabetes, Heart condition, Major psychiatric diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medication that requires eating at certain times, you may not be eligible to participate.

Is the eating pattern treatment generally safe for humans?

Research suggests that eating patterns, particularly the timing of meals, can influence health outcomes. Eating more in the evening may lead to weight gain and higher blood sugar levels, while morning eating might help reduce these risks. However, no specific safety concerns were identified for the eating pattern treatment itself. ^{1 2 3 4 5}

How does the DEPTH treatment for obesity differ from other treatments?

The DEPTH treatment is unique because it focuses on adjusting eating patterns based on the time of day, considering whether a person is more active in the morning or evening. This approach is different from traditional obesity treatments that may not consider the timing of food intake and its relationship with a person's natural body clock (chronotype). ^{6 7 8 9 10}

What data supports the effectiveness of the treatment DEPTH for obesity?

Research suggests that adjusting eating patterns to align with natural body clocks (chrono-nutrition) can lead to better weight loss outcomes. People who eat more earlier in the day and reduce night eating tend to lose more weight, indicating that timing of meals is important for managing obesity. ^{6 8 11 12 13}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My BMI is between 27 and 45.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-month lifestyle intervention with time-based energy intake goals, a reduced-calorie, low-fat diet, physical activity, and cognitive behavioral intervention

12 months

Assessments at 0, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DEPTH
• DEPTH-Evening
• DEPTH-Morning

Trial Overview 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.

How Is the Trial Designed?

Group I: DEPTH-Morning Experimental Treatment 2 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-Evening Experimental Treatment 2 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-Standard Active Control 1 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).

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Published Research Related to This Trial

In a study of 173 patients with severe obesity, four distinct eating patterns were identified, with the most common pattern (Profile 1) involving regular meals throughout the day, which did not vary with body mass index (BMI).

The study found that certain eating patterns, particularly those involving nighttime nibbling (Profiles 3 and 4), were linked to poorer psychological outcomes, suggesting that understanding a patient's eating habits could help identify those at higher risk for psychological issues related to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chrono-Nutritional Patterns, Medical Comorbidities, and Psychological Status in Patients with Severe Obesity. Bettini, S., Schiff, S., Carraro, E., et al.[2023]

In a 12-week study involving 91 overweight/obese non-shift workers, those who achieved a satisfactory weight loss (≥3% body weight) had a significantly higher intake of protein earlier in the day and reduced fat intake later in the day, indicating that timing and composition of meals are crucial for weight loss success.

Participants with satisfactory weight loss also had earlier last meal times and shorter eating windows, along with a notable reduction in night eating syndrome scores, suggesting that chrono-nutrition practices can effectively support weight reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in chrono-nutrition is associated with robust weight loss outcomes: An extension of the feasibility study. Mazri, FH., Manaf, ZA., Shahar, S., et al.[2023]

Individuals with a late chronotype (evening type) are more likely to be overweight or obese and have poorer metabolic health compared to those with an early chronotype (morning type), despite similar overall energy and macronutrient intakes.

Late chronotypes tend to consume more food during nighttime hours, which is associated with unhealthy eating behaviors and unfavorable dietary choices, contributing to their increased risk of obesity and metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotype Differences in Body Composition, Dietary Intake and Eating Behavior Outcomes: A Scoping Systematic Review. van der Merwe, C., Münch, M., Kruger, R.[2023]

In a study of 144 severely obese individuals, 73% reported poor sleep quality, while only 2.8% exhibited night-eating behavior, indicating that while sleep issues are prevalent, night eating is relatively uncommon.

A strong correlation (r=0.54) was found between poor sleep quality and night eating, suggesting that those with poor sleep may be more likely to engage in night eating, but this relationship is not affected by excessive daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlations between night eating, sleep quality, and excessive daytime sleepiness in a severely obese UK population. Cleator, J., Abbott, J., Judd, P., et al.[2016]

In a study of 400 participants, it was found that normal-weight individuals with a 'morningness' chronotype consumed most of their calories earlier in the day, while those with an 'eveningness' chronotype had higher calorie intake at dinner, indicating a link between chronotype and dietary habits.

Overweight and obese individuals showed disrupted eating patterns that did not align with their biological rhythms, suggesting that dietary interventions should consider chronotype to improve weight management and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association among chronotype, timing of food intake and food preferences depends on body mass status. Muñoz, JSG., Cañavate, R., Hernández, CM., et al.[2018]

In a study of 599 adults, morning chronotypes exhibited 85% higher self-regulation of eating behavior (SREB) compared to evening chronotypes, suggesting that chronotype influences dietary self-control.

Evening chronotypes were found to be more tempted by unhealthy foods like fried foods and chips, indicating a potential area for dietary intervention strategies to improve their eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morning individuals in Saudi Arabia have higher self-regulation of eating behavior compared to evening types. Al-Hazmi, MH., Noorwali, EA.[2023]

In a study of 23,003 US adults using data from the National Health and Nutrition Examination Survey, night-time eating was not found to be associated with body weight status, including BMI and obesity measures.

The results suggest that simply restricting food intake at night without reducing overall daily caloric intake may not effectively prevent obesity, indicating the need for further research on dietary behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Night-time eating and body weight status among US adults, 2007-2016. An, R., Shi, Y., Clarke, C., et al.[2020]

Eating the same amount of calories in the evening led to significant weight gain and increases in body mass index (BMI) and waist circumference, while morning eating did not affect these measurements, suggesting that timing of food intake is crucial for weight management.

Morning feeding was associated with lower fasting blood glucose and HbA1c levels, indicating a protective effect against metabolic syndrome, whereas evening feeding resulted in higher blood glucose levels and increased HbA1c, which are risk factors for obesity and related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of circadian restricted feeding on parameters of metabolic syndrome among healthy subjects. Singh, RB., Cornelissen, G., Mojto, V., et al.[2021]

In a study of 81 adults with obesity, those with a morning chronotype (MC) spent significantly more time eating lunch and dinner compared to evening chronotype (EC) individuals, who ate faster.

The faster eating speed of EC individuals may contribute to their higher risk of obesity-related cardiometabolic diseases, highlighting the importance of chronotype in dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Fast Do "Owls" and "Larks" Eat? Verde, L., Docimo, A., Chirico, G., et al.[2023]

In a study involving 2265 employees from 34 worksites, greater morning snacking was linked to increased consumption of fruits and vegetables, suggesting a positive dietary behavior.

Conversely, evening snacking was associated with higher BMI and unhealthy eating habits, indicating that reducing evening snacks could be a key strategy for preventing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating Occasions, Obesity and Related Behaviors in Working Adults: Does it Matter When You Snack? Barrington, WE., Beresford, SAA.[2020]

In a study of 499 participants over one year, having more eating episodes each day was linked to a lower risk of obesity, suggesting that frequent meals may help maintain a healthy weight.

Conversely, skipping breakfast significantly increased the likelihood of obesity, with participants who skipped breakfast having an odds ratio of 4.5 for obesity, indicating a strong association between breakfast habits and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between eating patterns and obesity in a free-living US adult population. Ma, Y., Bertone, ER., Stanek, EJ., et al.[2022]

In a study of 850 Iranian adults, researchers found no significant relationship between chronotype (morning vs. evening preference) and obesity-related measures or unhealthy eating habits, suggesting that chronotype may not influence these factors in this population.

Both morning and intermediate/evening chronotypes were present in the sample, but the study indicated that intermediate/evening types did not show higher obesity or unhealthy eating patterns after accounting for other factors like education and employment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of chronotype with eating habits and anthropometric measures in a sample of Iranian adults. Zeraattalab-Motlagh, S., Lesani, A., Majdi, M., et al.[2022]

In a study of 1912 Greek children aged 9 to 13, late-night overeating was linked to a higher likelihood of skipping breakfast and consuming fewer calories at breakfast, suggesting a negative impact on healthy eating habits.

For children with low physical activity levels, higher calorie intake at dinner was associated with an increased body mass index, while this relationship was reversed for those with high physical activity, indicating that activity levels may influence the effects of late-night eating on weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late-night overeating is associated with smaller breakfast, breakfast skipping, and obesity in children: The Healthy Growth Study. Karatzi, K., Moschonis, G., Choupi, E., et al.[2018]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Chrono-Nutritional Patterns, Medical Comorbidities, and Psychological Status in Patients with Severe Obesity. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Improvement in chrono-nutrition is associated with robust weight loss outcomes: An extension of the feasibility study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Chronotype Differences in Body Composition, Dietary Intake and Eating Behavior Outcomes: A Scoping Systematic Review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Correlations between night eating, sleep quality, and excessive daytime sleepiness in a severely obese UK population. [2016]

5. England pubmed.ncbi.nlm.nih.gov

The association among chronotype, timing of food intake and food preferences depends on body mass status. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Morning individuals in Saudi Arabia have higher self-regulation of eating behavior compared to evening types. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Night-time eating and body weight status among US adults, 2007-2016. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of circadian restricted feeding on parameters of metabolic syndrome among healthy subjects. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

How Fast Do "Owls" and "Larks" Eat? [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Eating Occasions, Obesity and Related Behaviors in Working Adults: Does it Matter When You Snack? [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Association between eating patterns and obesity in a free-living US adult population. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Association of chronotype with eating habits and anthropometric measures in a sample of Iranian adults. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Late-night overeating is associated with smaller breakfast, breakfast skipping, and obesity in children: The Healthy Growth Study. [2018]