Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863598
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-04-28
Brief Title:
Prevention of Eating Disorders Through Optimization of Protective Factors
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Randomized Controlled Trial of an Interactive Non-Stigmatizing Intervention to Prevent Eating Disorders in Youths Through Strengthening of Protective Factors
Status:
RECRUITING
Status Verified Date:
2023-05
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 thin randomized controlled trial is to investigate the efficacy of a prevention program for reducing the incidence of eating disorders among youth 15-20 We target youth at these ages who experience a subjective sense of body dissatisfaction and are thus at increased risk of developing an eating disorder
The prevention program is based on improving protective factors such as body appreciation body image flexibility intuitive eating and acceptance It will be compared to a credible placebo expressive writing
The prevention program is based on improving protective factors such as body appreciation body image flexibility intuitive eating and acceptance It will be compared to a credible placebo expressive writing
Detailed Description:
Research area and aims
Eating disorders EDs are common and cause significant morbidity and mortality Due to stigma only 25 seek help and only 50 fully recover after receiving treatments Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level However current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable brief and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization
Research questions
1 How effective is an internet-based prevention program that reinforces protective factors against EDs in reducing the onset of EDs 6 12 24 and 36 months post-intervention
2 Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors mediators
3 Is prevention of EDs based on reinforcement of protective factors cost-effective
4 How do the participant experience their participation in these two interventions
Other research questions concern gender differences in enrollment and compliance potential moderators of outcome participation in booster sessions and potential risk for stigma
Eating disorders EDs are common and cause significant morbidity and mortality Due to stigma only 25 seek help and only 50 fully recover after receiving treatments Large-scale prevention is urgently needed to reduce the emergence and burden of EDs at a population level However current prevention programs do not meet requirements for efficient and economically attractive large-scale implementation The main aim of this project is to investigate the efficacy and cost-effectiveness of a scalable brief and interactive prevention program based on reinforcement of protective factors against EDs using a randomized controlled design A focus on protective factors disrupts the processes by which risk factors increase the probability for EDs to emerge and minimizes the risks for stigmatization
Research questions
1 How effective is an internet-based prevention program that reinforces protective factors against EDs in reducing the onset of EDs 6 12 24 and 36 months post-intervention
2 Does the intervention reduce the incidence of EDs through enhancement of specifically targeted protective factors mediators
3 Is prevention of EDs based on reinforcement of protective factors cost-effective
4 How do the participant experience their participation in these two interventions
Other research questions concern gender differences in enrollment and compliance potential moderators of outcome participation in booster sessions and potential risk for stigma
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