Clinical trial NCT06547567: Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
Official title: Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Stages of Behavior Change
timeFrame: 2 years
measure: Obesity Status (BMI)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: