Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519539
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-16
Brief Title:
Implementing Strategies for Eating Behaviour Modification Based on Portion Control
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementing Strategies for Eating Behaviour Modification Based on Portion Control Methodological Development and Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
PORTIONS-4
Brief Summary:
This is a pre-post intervention study designed to evaluate the feasibility of a self-applied weight management intervention based on portion control A total of 40 healthy volunteers with overweightobesity will take part in a 6-month intervention featuring 4 components a portion control toolset a manual including instructions for the use of the tools dietary and activity recommendations and behavioural strategies a mobile app to motivate intervention engagement and biweekly telephone support The primary outcome will be Intervention adherence assessed as the change in dietary energy density meal nutrient composition and utilization of intervention components from start to end of trial Other measurements at baseline 3 and 6 months from baseline will include body composition fasting biochemical parameters inhibitory control eating behaviour portions size norms and acceptance of the intervention
Detailed Description:
According to recent meta-analyses portion control tools represent an acceptable and potentially effective strategy to aid in weight loss However how well these tools work depends on their consistent use and a good integration with other lifestyle modification strategies around body weight control and overall health The present pilot study was designed to evaluate the feasibility of a self-applied weight management intervention based on portion control and to identify factors influencing adherence The sample will consist of 40 healthy volunteers with overweightobesity who will engage in a pre-post intervetion study lasting six-months The intervetion will include four components 1 a portion control toolkit serving spoon and oil dispenser 2 a phsyical manual with instructions for using the tools dietary and physical activity recommendations and strategies to build habits and improve mental wellbeing 3 a mobile app to motivate intervention engagement and 4 biweekly short telephone support Adherence to the intervention will be the primary outcome assessed on a fortnightly basis as the change from baseline in dietary energy density and change in meal nutrient composition plus frequency of using the intervention components Other measurements that will be taken at baseline 3 and 6 months from baseline will be body composition fasting biochemical parameters inhibitory control only baseline and 6 months eating behaviour portion size norms and intervention acceptance After 3 months of taking part in the intervention a subset of the sample will participate in a nominal group session aimed at identifying barriers to intervention adherence and strategies to overcome them The study results will inform the design of a full-scale controlled trial featuring the most successful components
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