Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-04
Brief Title:
The MIND-GUT Digital Pilot Intervention Study
Sponsor:
University of Skövde
Organization:
University of Skövde
Study Overview
Official Title:
Exploring the Interplay Between Diet Obesity Mental Health and the Gut Microbiome The MIND-GUT Digital Pilot Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MINDGUT
Brief Summary:
This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet obesity mental health and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50 Participants excluding those with specific medical conditions will be randomly assigned to either an intervention or control group using a meal planning smartphone app Clinical assessments will include anthropometry mental health questionnaires dietary recalls and stool sample collections The studys endpoints include program retention adherence changes in body weight mental health and gut microbiome diversity Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome This pilot study has implications for health policies public healthcare digital health companies and the biotech and pharmacology industries Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations
Detailed Description:
Objective of the Pilot Study and Study Design
This 12-week randomized pilot intervention study aims to assess the feasibility and effectiveness of a dietary intervention targeting diet obesity mental health and the gut microbiome in promoting weight loss and enhancing mental health among obese individuals aged 30-50
Participant Recruitment and Randomization
Participants aged 30-50 excluding those with specific medical conditions such as psychiatric medication use food allergies affecting diets eating disorders diabetes polycystic ovary syndrome sensory deficits recent antibiotic use participation in other studies language limitations coeliacinflammatory bowel disease planned weight management within 3 months and pregnantlactatingpost-menopausal women will be recruited for the study Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app
Clinical Assessments
Clinical assessments will include anthropometry mental health questionnaires dietary recalls and stool sample collections
Study Endpoints
The studys endpoints include program retention adherence changes in body weight mental health and gut microbiome diversity
Statistical Analyses
Statistical analyses will evaluate the study feasibility intervention effects on body weight and mental health changes and the potential mediating roles of these effects by the gut microbiome
Implications and Future Plans
This pilot study has implications for health policies public healthcare digital health companies and the biotech and pharmacology industries Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations
This 12-week randomized pilot intervention study aims to assess the feasibility and effectiveness of a dietary intervention targeting diet obesity mental health and the gut microbiome in promoting weight loss and enhancing mental health among obese individuals aged 30-50
Participant Recruitment and Randomization
Participants aged 30-50 excluding those with specific medical conditions such as psychiatric medication use food allergies affecting diets eating disorders diabetes polycystic ovary syndrome sensory deficits recent antibiotic use participation in other studies language limitations coeliacinflammatory bowel disease planned weight management within 3 months and pregnantlactatingpost-menopausal women will be recruited for the study Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app
Clinical Assessments
Clinical assessments will include anthropometry mental health questionnaires dietary recalls and stool sample collections
Study Endpoints
The studys endpoints include program retention adherence changes in body weight mental health and gut microbiome diversity
Statistical Analyses
Statistical analyses will evaluate the study feasibility intervention effects on body weight and mental health changes and the potential mediating roles of these effects by the gut microbiome
Implications and Future Plans
This pilot study has implications for health policies public healthcare digital health companies and the biotech and pharmacology industries Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations
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