Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
CHOICE to AVOID or RESIST
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CHOICE to AVOID or RESIST Evaluating Participants Choice of Self-regulatory Strategy on Weight Management Outcomes A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This trials will formally test whether participants active choice of self-regulatory strategies AVOID or RESIST leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention AVOIDRESIST IRB STUDY00001652 AVOID-RESIST
Detailed Description:
Since we initiated recruitment for the AVOIDRESIST trial IRB STUDY00001652 AVOID-RESIST we have noted that some participants have a strong initial inclination for one of the self-regulatory strategies Some individuals have clearly expressed which strategy they believed would work for them while others have voiced dislike or skepticism for an assigned intervention component While attrition in the last 18 months 125 is comparable to trials of similar size and scope over 56 n18 of withdrawals were explicitly n3 or tangentially n15 related to intervention assignment
This pilot study CHOICE seeks to leverage our ongoing R01 to test whether participants active choice of behavior change pathways and strategies leads to better adherence retention and engagement Consistent with ongoing procedures women and men with overweight or obesity BMI between 25-45 kgm2 will be enrolled in the WW digital program for 12 months R01 participants will continue to be randomized to one of the 4 study arms 1 WW alone 2 WW AVOID 3 WW RESIST 4 WW AVOID RESIST CHOICE participants will be asked to choose which self-regulatory strategy AVOID or RESIST they want to receive to promote behavior change consistent with WW recommendations
This pilot study CHOICE seeks to leverage our ongoing R01 to test whether participants active choice of behavior change pathways and strategies leads to better adherence retention and engagement Consistent with ongoing procedures women and men with overweight or obesity BMI between 25-45 kgm2 will be enrolled in the WW digital program for 12 months R01 participants will continue to be randomized to one of the 4 study arms 1 WW alone 2 WW AVOID 3 WW RESIST 4 WW AVOID RESIST CHOICE participants will be asked to choose which self-regulatory strategy AVOID or RESIST they want to receive to promote behavior change consistent with WW recommendations
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