Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-01 @ 9:50 AM
Study NCT ID:
NCT05935592
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BMI z-score', 'timeFrame': 'T1 (baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)', 'description': 'BMI z-score calculation based on measured height and weight'}], 'secondaryOutcomes': [{'measure': 'Change in child dietary intake', 'timeFrame': 'T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)', 'description': '17-item questionnaire completed by child participants assessing frequency of consumption of fruit/vegetables, water, junk food, and sugary drinks during the past seven days'}, {'measure': 'Change in child dietary knowledge and attitudes', 'timeFrame': 'T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)', 'description': '45-item questionnaire completed by child participants assessing knowledge, outcome expectations, self-efficacy, and behavioral intention regarding behaviors associated with fruit/vegetables, water, junk food, and sugary drinks'}, {'measure': 'Change in parent feeding practices', 'timeFrame': 'T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)', 'description': '27-item questionnaire completed by parent participants assessing multiple parental feeding practices'}, {'measure': 'Change in home food environment', 'timeFrame': 'T1 (baseline), T2 (intervention end, 12-weeks post-baseline), T3 (maintenance intervention end, 6 months post-T2), T4 (follow-up, 12 months post T2)', 'description': '6-item questionnaire completed by parent participants assessing availability of fruits/vegetables and water in their home and how often they store fruits/vegetables and water in a place easily seen by their child'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood']}, 'descriptionModule': {'briefSummary': 'Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.', 'detailedDescription': "Childhood obesity continues to be a serious clinical and public health issue in the United States (US), particularly within low-income, minority groups. Effective, yet engaging interventions, such as the one developed by our team, are needed to capture the attention of children living in a multi-media environment.\n\nPotentially eligible pediatric patients (and their parent/caregiver) will be recruited from two of Children's Aid community-based clinics in NYC - Dunlevy Milbank Center based in Harlem and the Bronx Health Center based in the South Bronx. A variety of recruitment methods will be deployed, including in-person/flyer-based recruitment in clinic waiting rooms, healthcare provider referrals, and direct calls.\n\nAt baseline, eligible participants will be randomized to either the experimental group or comparison group (allocation ratio 1:1). Randomization will be performed at the dyad level and will be balanced on child ethnicity (Hispanic or Non-Hispanic), child biological sex (male, female), and clinic site.\n\nThe experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors. The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors. To minimize bias, participants will be blinded to the study's hypothesis.\n\nData will be collected at four timepoints: baseline (T1), main intervention end (T2), maintenance intervention end (T3), and at 12-month follow-up (T4). The primary outcome measure (BMI z-score) will be calculated using height and weight data captured via combined scale/stadiometer by a trained healthcare provider at T1, T3, T4. Secondary measures (dietary intake and dietary knowledge \\& attitudes of child participants; feeding practices and the home food environment by the parent/caregiver) will be captured via questionnaires at T1, T2, T3, T4."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (child):\n\n* self-identifies as Black/African-American and/or Latino\n* between ages 8 and 12 years (preadolescents) at time of scheduled baseline visits\n* reads and speaks in English\n* has a Body Mass Index percentile at or above 5% at baseline (categorized as healthy, overweight, or obese)\n* has regular internet access via a tablet device, smartphone, or computer/laptop\n* has regular access to a phone with texting capability\n* is comfortable reading/viewing material on electronic devices\n* is comfortable speaking with study staff about thoughts/experiences while participating in study\n* has a legal parent/guardian willing to participate in study\n\nInclusion Criteria (parent):\n\n* legal parent/guardian of child willing to participate in study\n* reads and speaks in English or Spanish\n* primarily responsible for preparing/purchasing food for child\n* has regular internet access via a tablet device, smartphone, or computer/laptop\n* has regular access to a phone with texting capability\n* comfortable reading/viewing material on electronic devices\n* able to attend in-person study visits and complete online questionnaires with their child over the full duration of study\n\nExclusion Criteria (child):\n\n* has allergies, food aversions, food disorders, or medications with side-effects that may impact participation in study\n* has a pacemaker or heart condition\n* in foster care'}, 'identificationModule': {'nctId': 'NCT05935592', 'briefTitle': 'Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents', 'orgStudyIdInfo': {'id': 'STUDY00004065'}, 'secondaryIdInfos': [{'id': '5R01HS028650-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01HS028650-03', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The experimental group will receive access to Intervention INC, a theory-guided interactive, family-centered web-based tool promoting healthy dietary behaviors.', 'interventionNames': ['Behavioral: Web-based comic and newsletters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Group', 'description': 'The comparison group will receive access to web-based newsletters focused on promoting healthy dietary behaviors.', 'interventionNames': ['Behavioral: Didactic health information']}], 'interventions': [{'name': 'Web-based comic and newsletters', 'type': 'BEHAVIORAL', 'description': 'Web-based comic and health messages (child component) and health newsletters (parent component)', 'armGroupLabels': ['Experimental Group']}, {'name': 'Didactic health information', 'type': 'BEHAVIORAL', 'description': 'Web-based newsletters (for child and parent) by email and/or text', 'armGroupLabels': ['Comparison Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10026', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sophia Gigos-Costeas, MD, MPH, FAAP', 'role': 'CONTACT', 'email': 'projectgameon@tufts.edu', 'phone': '646-883-5163'}], 'facility': "Milbank Health Center - Children's Aid", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10460', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sophia Gigos-Costeas, MD, MPH, FAAP', 'role': 'CONTACT', 'email': 'projectgameon@tufts.edu', 'phone': '646-883-5163'}], 'facility': "Bronx Health Center - Children's Aid", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'May May Leung, PhD, RDN', 'role': 'CONTACT', 'email': 'maymay.leung@tufts.edu', 'phone': '617-636-3676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Aid, New York City", 'class': 'UNKNOWN'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Hunter College of City University of New York', 'class': 'OTHER'}, {'name': 'City University of New York, School of Public Health', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}