Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455995
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-06
Brief Title:
Daily Eating Patterns for Total Health Study
Sponsor:
The University of Tennessee Knoxville
Organization:
The University of Tennessee Knoxville
Study Overview
Official Title:
Effect of Time-based Energy Intake Goals on Weight Loss During Obesity Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEPTH
Brief Summary:
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 persons 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
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 persons 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
Detailed Description:
This randomized controlled trial investigates the longer-term 12 months effect of time-based energy intake goals on weight loss It also explores whether enhanced appetite regulation is a mediator of the relationship and if chronotype moderates the effect Adults with overweight or obesity are randomly assigned to one of three 12-month lifestyle interventions 1 Morning 2 Evening or 3 Standard All conditions receive a reduced-energy low-fat dietary prescription 1200-1500 kcald 30 energy from fat physical activity goals 200 minwk 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 are consistent across all three conditions Thus the three conditions are 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 Morning group has 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 Evening group has the opposite time-based energy intake goals an afternoonevening-loaded energy distribution Standard group receives no guidance on energy intake distribution standard lifestyle intervention Assessments occur at 0 3 6 and 12 months on anthropometrics diet 24-hr recalls with time-stamped digital images verifying timing of intake combined with continuous blood glucose monitoring CGM to objectively assess for length of the eating window and number of eating occasions sleep regularity actigraphy supported by sleep logs collected via ecological momentary assessment EMA using smartphones appetite regulation assessed via EMA using smartphones chronotype self-reported midpoint of sleep on work-free days and MVPA actigraphy
The primary aims are to determine
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
The exploratory aims are to consider
1 If appetite regulation mediates the relationship between time-based energy intake goals and weight loss
2 The moderating effect of chronotype on weight loss and changes in eating temporal patterns sleep regularity and appetite regulation in the three conditions
The primary aims are to determine
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
The exploratory aims are to consider
1 If appetite regulation mediates the relationship between time-based energy intake goals and weight loss
2 The moderating effect of chronotype on weight loss and changes in eating temporal patterns sleep regularity and appetite regulation in the three conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None