Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963971
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-29
Brief Title:
A Bilingual Virtually-based Intervention PEDALL for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Bilingual Virtually-based Intervention PEDALL for the Prevention of Weight Gain in Childhood ALL Patients Considering Key Genetic and Sociodemographic Risk Factors
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PEDALL
Brief Summary:
The purpose of this study is determine the effectiveness of a six-month virtually-delivered dietary education intervention PEDALL on the prevention of overweight and obesity OWOB during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia ALL
Detailed Description:
Acute lymphoblastic leukemia ALL has been referred to as a pre-obese state with many studies describing the onset of obesity during treatment Weight gain typically begins within the first month of ALL diagnosis stabilizes and then resumes at the beginning of maintenance and continues into survivorship Children and adolescents with healthy weight at diagnosis are the most vulnerable to weight gain up to 70 develop overweightobesity OWOB by the end of treatment EOT Weight gain during treatment is one of the most consistently reported risk factors for weight gain in survivorship and is associated with an increased odds of being OWOB 5-years post-EOT Significant clinical ramifications are associated with being OWOB A meta-analysis led by the Childrens Oncology Group nutrition committee found that OWOB is associated with a 31 increased risk of mortality in ALL
The objective of the study team is to prevent the development of OWOB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention PEDALL in English and Spanish speaking families of children and adolescents undergoing treatment for ALL Once enrolled subjects will be randomized to PEDALL or standard of care SOC Subjects in the PEDALL group will receive 26 contact hours of specialized nutrition education and counseling via a virtual platform
The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OWOB compared to SOC during maintenance chemotherapy The clinical impact of this study will improve the understanding of pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight gain among patients treated for ALL Study findings may lead to the allocation of limited clinical resources to individuals most susceptible to OWOB Information obtained from this study may also direct the refinement of counseling techniques to enhance the likelihood of success over the course of treatment for ALL and into survivorship The long-term goal is to enhance the likelihood of success of weight maintenance during therapy thereby mitigating excess toxicities during treatment and reducing nutrition-related late-effects associated with OWOB among survivors of childhood ALL
The objective of the study team is to prevent the development of OWOB during maintenance chemotherapy using a six-month virtually delivered dietary education intervention PEDALL in English and Spanish speaking families of children and adolescents undergoing treatment for ALL Once enrolled subjects will be randomized to PEDALL or standard of care SOC Subjects in the PEDALL group will receive 26 contact hours of specialized nutrition education and counseling via a virtual platform
The purpose of this study is to determine the effectiveness of a virtually-delivered dietary education intervention in the prevention of OWOB compared to SOC during maintenance chemotherapy The clinical impact of this study will improve the understanding of pre-treatment factors predictive of the efficacy of intervention to prevent unhealthy weight gain among patients treated for ALL Study findings may lead to the allocation of limited clinical resources to individuals most susceptible to OWOB Information obtained from this study may also direct the refinement of counseling techniques to enhance the likelihood of success over the course of treatment for ALL and into survivorship The long-term goal is to enhance the likelihood of success of weight maintenance during therapy thereby mitigating excess toxicities during treatment and reducing nutrition-related late-effects associated with OWOB among survivors of childhood ALL
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AAAU5938 | OTHER | Columbia University Institutional Review Board | None |