Health TrialsbyHealthPanel

Mothers' Action Project for Child Health

ConditionsDental CariesObesity Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-45
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >=18;

Speaks and reads/writes Bengali or Hindi/Urdu;

Mother born in a South Asian country;

Mother is primary caretaker of child

Disqualifiers

Unable to provide informed consent,

Lack of availability--either plans to travel for > 1 month during 12 month initial study period or other barriers to attendance;

Mother has exclusionary health condition--either intellectual/cognitive or medical.

Weighed < 5lbs at birth,

Trial design

Design model

Parallel

Treatments tested in this trial

  • health education and social network building

    Behavioral

    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. Educational materials and vetted dentist referrals, plus navigation to dentist visits, will be provided.

  • dental referral and educational materials

    Behavioral

    Control arm will receive a referral to vetted dentist and educational materials on child health

Treatment groups

460 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

NIDCR ECC Collaborative Criteria Dental Exam

The investigators will assess 18 month incidence in dental caries using dental hygienist exams at baseline and 18 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.

Time frame
18 months

Secondary outcomes

1

Weight Gain Velocity

We will measure child weight and height/length at 0, 12 and 18 months. Research staff will obtain weight and height data at baseline, 12 and 18 m. For children under 24 months of age, 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 18 months.

Time frame
18 months
2

Infant Feeding Styles Questionnaire--Adapted

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.

Time frame
18 months
3

Oral Hygiene and Dental Utilization Questionnaire

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.

Time frame
18 months
4

Food frequency Questionnaire

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.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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