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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2024-08-04', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stages of Behavior Change', 'timeFrame': '2 years', 'description': 'The main survey indicators include personality traits, autonomous motivation, behavioral attitudes, subjective norms, perceived behavioral control, behavioral intentions, stages of behavior change, obesity-related behaviors'}, {'measure': 'Obesity Status (BMI)', 'timeFrame': '2 years', 'description': 'The main survey indicators include obesity status, such as BMI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Obesity']}, 'descriptionModule': {'briefSummary': '1\\. Study Population\n\n1. Sample Size: 150 children.\n2. 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.\n3. Inclusion Criteria (all of the following must be met for inclusion):\n\n Both children/adolescents and their parents are willing to participate and demonstrate good compliance.\n\n 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.\n4. Exclusion Criteria (meeting any one of the following will result in exclusion):\n\nPathological 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.\n\nHistory of or plans to undergo pharmacological or surgical weight loss interventions within the next two years.', 'detailedDescription': '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.\n\nIntervention 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:\n\nEngagement tasks, exploration tasks, expansion tasks, action planning tasks.\n\nFollow-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both children/adolescents and their parents are willing to participate and demonstrate good compliance.\n* Children/adolescents have a weight classified as normal, overweight, or obese.\n* Age range: 10 to 14 years.\n* Informed consent is obtained from both the child and the parent.\n\nExclusion Criteria:\n\n* Pathological obesity (e.g., due to endocrine disorders).\n* Clinically diagnosed severe mental illness or psychiatric disorders.\n* Clinically diagnosed eating disorders (e.g., binge eating disorder).\n* Physical developmental abnormalities or disabilities that prevent normal physical activity.\n* History of or plans to undergo pharmacological or surgical weight loss interventions within the next two years.'}, 'identificationModule': {'nctId': 'NCT06547567', 'briefTitle': 'Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing', 'orgStudyIdInfo': {'id': 'PU IRB V1 (2023-10-31)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing Group', 'description': '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.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Health Education Intervention', 'description': '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.'}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Motivational Interviewing Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}