Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing

NCT ID: NCT06547567

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2027-01-31

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.

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Motivational Interviewing Group

In addition to receiving the same health education intervention as the control group, the children and adolescents in the intervention group will undergo a group-based motivational interviewing intervention. This will be conducted by a professional team that has been trained and is qualified in motivational interviewing. The intervention will embody the spirit of motivational interviewing and the stages of group motivation development, primarily including: introductory tasks, exploratory tasks, expansion tasks, and action planning tasks.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

In addition to receiving the same health education intervention as the control group, the children and adolescents in the intervention group will undergo a group-based motivational interviewing intervention. This will be conducted by a professional team that has been trained and is qualified in motivational interviewing. The intervention will embody the spirit of motivational interviewing and the stages of group motivation development, primarily including: introductory tasks, exploratory tasks, expansion tasks, and action planning tasks.

Health Education Intervention

Using various methods such as WeChat official accounts, video platforms, WeChat groups, and the distribution of health education pamphlets, we aim to disseminate scientific knowledge and practical skills related to healthy weight management and the prevention of overweight and obesity to children, adolescents, and their parents.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational Interviewing

In addition to receiving the same health education intervention as the control group, the children and adolescents in the intervention group will undergo a group-based motivational interviewing intervention. This will be conducted by a professional team that has been trained and is qualified in motivational interviewing. The intervention will embody the spirit of motivational interviewing and the stages of group motivation development, primarily including: introductory tasks, exploratory tasks, expansion tasks, and action planning tasks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Pathological obesity (e.g., due to endocrine disorders).
• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PU IRB V1 (2023-10-31)

Identifier Type: -

Identifier Source: org_study_id