Obesity Clinical Trial
Official title:
Pilot Testing of Baby Feed: A Web Application for Health Professionals and Parents to Improve Infant Diets
Verified date | April 2023 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project will pilot test "Baby Feed" online web portals among clinicians and parents to learn about their experience with the portals. Baby Feed evaluates infant diets online using a validated Infant Food Frequency Questionnaire, provides immediate results online to health care providers on nutrients and foods/beverages consumed above or below the recommended levels, provides current diet recommendations by infant's age online, and helps track progress at home. The investigators will recruit 2 clinicians from Borinquen Health Care Center in Miami and 50 of their patients (parents with infants) scheduled for a routine Well-Child Visit when infants are 4-12 months old. Participants will be equally randomized to the intervention group or the control group. If randomized to Baby Feed, parents will discuss the results with the healthcare professional and track their infants' diets at home. Parents in the Control group will only complete the infant FFQ online but will not have access to the other features of Baby Feed. After 3 months, the investigators will evaluate the infant diet and weight gain during this period.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Months to 12 Months |
Eligibility | Inclusion Criteria: - parent/guardian responsible for infant's care; - parent of an infant age 4 to 12 months, who is healthy and with any weight status; - have internet access; - willing to participate for the full study duration of 2 weeks; Exclusion criteria: - parents of infants with special diets, limited mobility, preterm birth of < 37 weeks, birthweight < 10th or > 90th percentile; - parent/guardian unable to consent to participate. |
Country | Name | City | State |
---|---|---|---|
United States | Borinquen Medical Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University |
United States,
Palacios C, Bolton J, Wang W, Gatto A, Concepcion L, Sadjadi M, Varella M, Hannan J. Development and pilot testing of the Baby-Feed web application for healthcare professionals and parents to improve infant diets. Int J Med Inform. 2023 Mar 17;174:105047. doi: 10.1016/j.ijmedinf.2023.105047. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infant's diet | Results from the infant FFQ will be analyzed to calculate if percentage change of the foods and beverages consumed above or below the recommended levels changed during this study period | 3 months | |
Primary | Diet quality using the Diet Quality Index Score (DQIS) | Using the results from the infant FFQ, the investigators will calculate the DQIS score, which is composed of 9 food groups: breastfeeding and milk, grains, proteins, vegetables, fruits, 100% juices, sugar-sweetened beverages, sweets, and salty snacks. A total of 5 points are assigned if the intake is within the recommended amounts, 2.5 points if the intake is slightly over or under recommended amount, and 0 points if the intake is excessive or not consumed. The points are summed, and diet quality is categorized as Excellent (score: 45-55), Good (score: 35-44), Needs Improvement (score: 25-34), and Poor (score: 0-24). | 3 months | |
Secondary | Rate of weight gain | The investigators will calculate the weight z score and weight-for-length z score using the WHO Anthro Survey Analyzer. The rate of weight gain will be calculated as the change in weight z score between visits and categorized as: (1) Adequate weight gain (change of -0.67 to 0.67 standard deviations; (2) Rapid weight gain in (change > 0.67 standard deviations); (3) Slow weight gain (change of < -0.67 standard deviations). | 3 months | |
Secondary | Parenting Self-Efficacy | This will be assessed using a validated questionnaire, as mediator of behavioral change. The investigators will evaluate changes in the level of confidence that parents feel about feeding their baby between baseline and follow up visits. | 3 months |
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