Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583447
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Time Restricted Eating in Childhood Obesity TRECO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Time Restricted Eating in Childhood Obesity An Open-Label Blinded-Endpoint Parallel-Controlled Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRECO
Brief Summary:
The goal of this clinical trial is to learn if time-restricted eating TRE an alternative method of reducing energy intake which has gained popularity in recent years works to treat obesity in children It will also learn about the safety and long-term adherence of 12-hour TRE in comparison to calory restricted diet CRD The main questions it aims to answer are
1 Is the weight-losing effect of 12-hour TRE better than CRD
2 Is 12-hour TRE easier to adhere to than CRD
Researchers will compare 12-hour TRE to CRD the primary treatment for obesity to see if 12-hour TRE works to treat childhood obesity
Participants will
1 Follow the 12-hour TRE or CRD diet every day for 48 weeks
2 Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests
3 Keep a diary of their diet physical activity and symptoms
1 Is the weight-losing effect of 12-hour TRE better than CRD
2 Is 12-hour TRE easier to adhere to than CRD
Researchers will compare 12-hour TRE to CRD the primary treatment for obesity to see if 12-hour TRE works to treat childhood obesity
Participants will
1 Follow the 12-hour TRE or CRD diet every day for 48 weeks
2 Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests
3 Keep a diary of their diet physical activity and symptoms
Detailed Description:
Childhood obesity is a major metabolic disorder affecting approximately 20 of children and adolescents Calory-restricted diet CRD is the primary treatment for obesity but adherence to CRD typically declines over time and many individuals who lose weight with this strategy regain it Accumulating evidence suggests that time-restricted eating TRE an alternative method of reducing energy intake that has gained popularity in recent years has a significant weight-losing effect on adult obesity However its weight-losing effect on childhood obesity is still lacking trial evidence
The overall objective of this study is to test the effectiveness of 12-hour TRE on weight loss for childhood obesity in comparison with CRD The secondary objective is to compare the long-term adherence and weight-losing effect between the two dietary interventions
The TRECO study is an open-label blinded endpoint parallel design randomized controlled trial planned to enroll 128 patients with childhood obesity 8-17 years old BMI-Z value gt2 randomized by sex and age 12 years old into zonal groups and on the basis of the conventional non-pharmacological interventions TRE was given to the intervention group and CRD was given to the control group and the short-term effect of TRE was observed after 12 weeks of intervention The short-term effect of TRE was observed after 12 weeks of intervention ie to compare the difference in the magnitude of BMI-Z reduction between the two groups The intervention was extended to 48 weeks to observe the long-term effect of TRE by comparing the difference in the reduction of BMI-Z between the two groups
The overall objective of this study is to test the effectiveness of 12-hour TRE on weight loss for childhood obesity in comparison with CRD The secondary objective is to compare the long-term adherence and weight-losing effect between the two dietary interventions
The TRECO study is an open-label blinded endpoint parallel design randomized controlled trial planned to enroll 128 patients with childhood obesity 8-17 years old BMI-Z value gt2 randomized by sex and age 12 years old into zonal groups and on the basis of the conventional non-pharmacological interventions TRE was given to the intervention group and CRD was given to the control group and the short-term effect of TRE was observed after 12 weeks of intervention The short-term effect of TRE was observed after 12 weeks of intervention ie to compare the difference in the magnitude of BMI-Z reduction between the two groups The intervention was extended to 48 weeks to observe the long-term effect of TRE by comparing the difference in the reduction of BMI-Z between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None