Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06753669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mothers' Action Project for Child Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1260}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIDCR ECC Collaborative Criteria Dental Exam', 'timeFrame': '24 months', 'description': 'The investigators will assess 24 month incidence in dental caries using dental hygienist exams at baseline and 24 months post baseline. The exams will be conducted in the home, in the knee to knee position or on the floor, using artificial light and a front plane mirror. The teeth will be dry brushed and wiped. An explorer will be used to remove debris to visualize the tooth surface except as specified for the assessment of hardness. No magnification will be allowed. The examiner will use a trained recorder.'}], 'secondaryOutcomes': [{'measure': 'Weight Gain Velocity', 'timeFrame': '24 months', 'description': 'We will measure child weight and height/length at 0, 12 and 24 months. Research staff will obtain weight and height data at baseline, 12 and 24 m. For children under 24 months, two supine measures will be taken using infantometers (Seca 417), to the nearest 0.1 cm. For children ≥24 months, a stadiometer will be used. If measurements differ by +/- 0.5 cm., a third measure will be taken, and the means averaged. Research quality scales will be used to assess weight. Primary outcome is change in weight/height over 24 months.'}, {'measure': 'Infant Feeding Styles Questionnaire--Adapted', 'timeFrame': '24 months', 'description': 'This measure assesses maternal feeding style, including pressured feeding. The original measure has been heavily adapted for the current population. The scale includes 19 items. The score ranges from 0 to 76 with a higher score indicating more problematic feeding styles.'}, {'measure': 'Oral Hygiene and Dental Utilization Questionnaire', 'timeFrame': '24 months', 'description': 'This 25 Item inventory, adapted for a previous study with a similar population, includes subscales covering the following domains: holding a bottle, sleeping with a bottle, tooth brushing, toothpaste, tap water, dental visits.'}, {'measure': 'Food frequency Questionnaire', 'timeFrame': '24 months', 'description': 'This seven day food frequency questionnaire has been adapted for use in the current study. It includes a variety of subscales focusing on food items relevant to weight gain and dental health including breast milk, formula, cows milk, sweetened beverages, sweets, junk food/snacks, and fruits/vegetables.'}, {'measure': 'Dental utilization', 'timeFrame': '24 months', 'description': 'Presence or absence of a dental visit AND # dental visits between baseline and 24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early childhood caries', 'child obesity', 'social network intervention'], 'conditions': ['Dental Caries', 'Obesity Risk']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will recruit Bangladeshi mothers and their young children into a 12 month intervention that provides child health and oral health education and seeks to build social networks among mothers.', 'detailedDescription': "MAP-CH is a cluster randomized clinical trial. A total of 180 proximally dwelling clusters of approximately 7 mothers will be randomized 1:1 to the intervention and control arms (90 clusters/arm). One child per family will be enrolled, resulting in a total sample size of 1260. The target population of this study is low-income SA mothers of young children aged 12-72 months.\n\nRecruitment: To identify eligible families for recruitment, the MAP-CH research staff will conduct a Mapping Project. Community health workers (CHWs) will identify clusters of eligible families living close together in SA neighborhoods. Accompanied by local contacts project staff will visit homes of potential participants and assess eligibility and recruit eligible consenting mothers.\n\nIntervention: Mothers assigned to the intervention group will participate in a 12-month, multi-session, group-based intervention. Intervention meetings will take place in participant homes and will be led in Bengali (or the language spoken by that cluster), by a skilled bilingual facilitator from our research staff. The intervention is designed to: 1) improve knowledge, attitudes, and behaviors related to reducing dietary sugar; and 2) increase maternal assertiveness and parenting skills related to healthy feeding; and 3) build lasting social networks supportive of these norms and behaviors among participants. Eighteen sessions will be delivered over 12 months.\n\nControl group: Mothers assigned to the control arm will receive a series of packages and mailings.\n\nData collection: Interviews will be conducted in the home, by RAs at T1/Baseline, T2 (12months' post baseline) and T3 (24 months' post baseline). Data collected at each interview includes anthropometric data collection; and questionnaires/interviews. Social network data will also be collected at T1, 3M, 6M, T1, 18M and T3. Dental caries assessments will occur at baseline and T3.\n\nAnalyses: The primary outcome is reduced d2-4mfs increment at 24 months' post baseline in the intervention compared to the control group. A secondary outcome is reduced weight gain. Other outcomes include servings of sweetened foods and beverages, servings of junk food, use of bottles, maternal feeding behaviors, oral hygiene, and dental utilization. The investigators will also evaluate potential mediators and moderators of treatment impact including knowledge, assertiveness, depression, household empowerment, and social network quality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMother:\n\n1 age 18-45; 2)speaks and reads/writes Bengali or Hindi/Urdu; 3) mother born in a South Asian country; 4) mother is primary caretaker of child\n\nChild:\n\nAged 12-48 months Has Medicaid or CHIP (NYS health plan for low income families not qualifying for Medicaid) -\n\nExclusion Criteria:\n\nMother:\n\n1\\) unable to provide informed consent, 2) has plans to travel for \\> month during first 12-month study period\n\nChild:\n\n1\\) weighed \\< 5lbs at birth, 2) has an exclusionary health condition and/or is taking long term (\\>1 m) antibiotics\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06753669', 'acronym': 'MAP-CH', 'briefTitle': "Mothers' Action Project for Child Health", 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': "Mothers' Action Project for Child Health", 'orgStudyIdInfo': {'id': '00000666'}, 'secondaryIdInfos': [{'id': 'UH3DE030070', 'link': 'https://reporter.nih.gov/quickSearch/UH3DE030070', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Health education and social network building', 'interventionNames': ['Behavioral: health education and social network building']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'The control arm will receive referrals to vetted dentists and educational materials on child feeding and oral health.', 'interventionNames': ['Behavioral: dental referral and educational materials']}], 'interventions': [{'name': 'health education and social network building', 'type': 'BEHAVIORAL', 'description': 'The investigators will use techniques from the social network literature to build each treatment group as a cohesive social network and will diffuse educational messages through these groups.', 'armGroupLabels': ['Intervention arm']}, {'name': 'dental referral and educational materials', 'type': 'BEHAVIORAL', 'description': 'Control arm will receive a referral to vetted dentist and educational materials on child health', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alison Karasz, PhD', 'role': 'CONTACT', 'email': 'alison.karasz@umassmed.edu', 'phone': '347-843-5652'}, {'name': 'Christine Fountain', 'role': 'CONTACT', 'email': 'cfountain1@fordham.edu', 'phone': '803-315-1780'}], 'overallOfficials': [{'name': 'Alison Karasz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Chan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Data will be available indefinitely as soon as all study analyses are complete', 'ipdSharing': 'YES', 'description': 'Demographics, social network, and outcome data', 'accessCriteria': 'Qualified researcher with a clear analysis plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alison Karasz', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}