Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02893150
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2016-08-29
Brief Title:
Mindfulness Intervention for Overweight Primary Care Patients
Sponsor:
Centro Mente Aberta de Mindfulness
Organization:
Centro Mente Aberta de Mindfulness
Study Overview
Official Title:
Mindfulness as a Complementary Intervention for Overweight Primary Care Patients Study Protocol for a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-10
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:
MindEat
Brief Summary:
Mindfulness has been applied in the United States and Europe to improve both physical and psychological health however it is still poorly studied in Brazil Mindfulness or its lack may also have particular relevance to obesity and eating disorders reducing the episodes of binge eating which are partly responsible for weight regain for many people and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process The hypothesis is that Mindfulness-based Interventions MBI as well as specific programmes focused on conscious eating as Mindfulness Based Eating Awareness Training MB-EAT can in short time and in a sustainable fashion improve biochemical psychometric and anthropometric parameters in primary care patients with overweight
Detailed Description:
A randomized-controlled trial will be conducted to compare treatment-as-usual TAU in Primary Care combined a generic MBI with 8 sessions developed by our research group called Mindfulness-Based Health Promotion MBHP program versus TAU plus MB-EAT It will be included women aged 18 and 60 literate with a BMI body mass index 25 kgm2 The primary outcome is the improvement of the eating behaviour measured by DEBQ Secondary outcomes are It is expected improvement of nutritional status reduction of body weight by at least 5 of the weight along the intervention as well as maintenance of this without weight regain which could lead to the prevention of multiple morbidities related to excess body weight Will be assessed the levels of Mindfulness stress anxiety psychometric scale and serum cortisol and self-compassion There will be performed basal baseline at post-intervention 3 and 6 months follow-up measurements The control group will receive the intervention that has been shown to be more effective at the end of the study MBHP or MB-EAT
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