Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547567
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
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:
1 Study Population
1 Sample Size 150 children
2 Randomization This study will employ a randomized controlled intervention design Participants will be stratified based on factors such as gender and age and within each stratum they will be randomly assigned in a 11 ratio to either the intervention group receiving motivational interviewing or the control group The randomization process will be centralized and conducted by personnel not involved in the project
3 Inclusion Criteria all of the following must be met for inclusion
Both childrenadolescents and their parents are willing to participate and demonstrate good compliance
Childrenadolescents have a weight classified as normal overweight or obese Age range 10 to 14 years Informed consent is obtained from both the child and the parent
4 Exclusion Criteria meeting any one of the following will result in exclusion
Pathological obesity eg due to endocrine disorders Underweight Clinically diagnosed severe mental illness or psychiatric disorders Clinically diagnosed eating disorders eg binge eating disorder Physical developmental abnormalities or disabilities that prevent normal physical activity
History of or plans to undergo pharmacological or surgical weight loss interventions within the next two years
1 Sample Size 150 children
2 Randomization This study will employ a randomized controlled intervention design Participants will be stratified based on factors such as gender and age and within each stratum they will be randomly assigned in a 11 ratio to either the intervention group receiving motivational interviewing or the control group The randomization process will be centralized and conducted by personnel not involved in the project
3 Inclusion Criteria all of the following must be met for inclusion
Both childrenadolescents and their parents are willing to participate and demonstrate good compliance
Childrenadolescents have a weight classified as normal overweight or obese Age range 10 to 14 years Informed consent is obtained from both the child and the parent
4 Exclusion Criteria meeting any one of the following will result in exclusion
Pathological obesity eg due to endocrine disorders Underweight Clinically diagnosed severe mental illness or psychiatric disorders Clinically diagnosed eating disorders eg binge eating disorder Physical developmental abnormalities or disabilities that prevent normal physical activity
History of or plans to undergo pharmacological or surgical weight loss interventions within the next two years
Detailed Description:
Intervention Content Control Group The control group will receive health education on weight management and the prevention of overweight and obesity through various channels including WeChat official accounts video platforms WeChat groups and the distribution of health education pamphlets This aims to disseminate scientific knowledge and practical skills to children adolescents and their parents
Intervention Group In addition to receiving the same health education interventions as the control group the intervention group will participate in group-based motivational interviewing This will be conducted by a professional team that has been trained and certified in motivational interviewing techniques The intervention will embody the principles of motivational interviewing and will follow a staged development approach which includes
Engagement tasks exploration tasks expansion tasks action planning tasks
Follow-up Survey This study will conduct a baseline survey and follow-up surveys at 3 6 12 18 and 24 months post-intervention The main survey indicators will include personality traits autonomous motivation behavioral attitudes subjective norms perceived behavioral control behavioral Intentions stages of behavioral change obesity-related behaviors obesity status mental health indicators
Intervention Group In addition to receiving the same health education interventions as the control group the intervention group will participate in group-based motivational interviewing This will be conducted by a professional team that has been trained and certified in motivational interviewing techniques The intervention will embody the principles of motivational interviewing and will follow a staged development approach which includes
Engagement tasks exploration tasks expansion tasks action planning tasks
Follow-up Survey This study will conduct a baseline survey and follow-up surveys at 3 6 12 18 and 24 months post-intervention The main survey indicators will include personality traits autonomous motivation behavioral attitudes subjective norms perceived behavioral control behavioral Intentions stages of behavioral change obesity-related behaviors obesity status mental health indicators
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