Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06486922
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-20
Brief Title:
Starting Early to Prevent Obesity Using Telehealth StEP OUT Intervention Development Trial
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Starting Early to Prevent Obesity Using Telehealth StEP OUT Intervention Development Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth StEP OUT intervention for feasibility and acceptability using human-centered design and community-engaged research methods
Detailed Description:
This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth StEP OUT an online group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy It is tailored to HispanicLatinx families StEP OUT will be delivered by a registered dieticiancertified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women Infants and Children LIJ WIC The StEP OUT curriculum is based on the Starting Early Program StEP which uses didactic instruction reflective discussion interactive demonstrations and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices The details of program structure and content will evolve as the study progresses based on feedback from participants interventionists and our Community Advisory Board Initially we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously primarily via remote videoconference though sessions may occur individually based on participant schedule and preference Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort The iterative intervention adaptation process will be complete once all participants rate the intervention as acceptable or higher and fidelity is 90 or higher We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations if necessary
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?:
False
Is an FDA AA801 Violation?:
None