Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-02 @ 10:28 AM
Study NCT ID:
NCT06547567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
Sponsor:
Peking University
Organization:
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:
False
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 1:1 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 children/adolescents and their parents are willing to participate and demonstrate good compliance.
Children/adolescents 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 (e.g., due to endocrine disorders). Underweight. Clinically diagnosed severe mental illness or psychiatric disorders. Clinically diagnosed eating disorders (e.g., 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 1:1 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 children/adolescents and their parents are willing to participate and demonstrate good compliance.
Children/adolescents 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 (e.g., due to endocrine disorders). Underweight. Clinically diagnosed severe mental illness or psychiatric disorders. Clinically diagnosed eating disorders (e.g., 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?:
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?: