SpoonfulONE for Infant Nutrition

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke Clinical Research Institute, Durham, NC
+1 More
SpoonfulONE - Other
Eligibility
< 18
All Sexes
Eligible conditions
Infant Nutrition

Study Summary

This study is evaluating whether a mobile application can help parents introduce new foods to their infants.

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Eligible Conditions

  • Infant Nutrition
  • Diet Diversity

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether SpoonfulONE will improve 1 primary outcome and 7 secondary outcomes in patients with Infant Nutrition. Measurement will happen over the course of Baseline.

12 months
Convenience, score through a questionnaire
Diet diversity, score
Mean age of participants when first introduced to various food groups, measured through a questionnaire
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
Month 18
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups
Proportion of participants on SpoonfulONE compared to the proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire
Baseline
Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Standard diet with daily SpoonfulONE

This trial requires 1500 total participants across 2 different treatment groups

This trial involves 2 different treatments. SpoonfulONE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard diet with daily SpoonfulONE
Other
Participants will receive one serving of SO (one of three possible forms of SO: mix-ins, puffs, or crackers) daily in addition to a standard diet. The SO form fed on a given day will be at the discretion of the parent/guardian.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months and 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months and 18 months for reporting.

Closest Location

Duke Clinical Research Institute - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female 4-6 months of age at time of consent
Provision of signed and dated informed consent form parent/guardian(s)
Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod
In good general health as evidenced by medical history reported by the parent/guardian(s)
No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for infant nutrition?

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A variety of nutrition management treatment options are available for infants, most commonly depending on their age and condition, such as breast milk or formula fed infants, non-breastfed infants, enteral nutrition such as orally administered formula, and parenteral nutrition.

Unverified Answer

What causes infant nutrition?

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While there were few clear differences in nutrient intakes between babies who got food through breastfeeding versus formula, our study did provide evidence that breastfed infants are more likely to grow rapidly than formula-fed infants who received similar amounts of calories from food. Infants who grow rapidly may need an additional source of nutrition, either from their mothers' milk or from other sources. Because we found no differences in nutrient intakes between breastfed and formula-fed babies, we found no evidence to support recommendations that mothers should use exclusive breastfeeding as a strategy to promote health.

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Can infant nutrition be cured?

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infant nutrition may be influenced by factors such as the maternal health, the presence of illness in the family, and the environment. Further research evaluating causal relationships between parental health, disease, and family environment is warranted.

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What are the signs of infant nutrition?

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Most newborns are fed by breast-feeding. Breast feeding in infants less than 6 months can cause the growth of stunted children and cause childhood weight gain. It has been shown that some infants who were breast-feeding exclusively and not being breast-fed by their mothers will suffer from malnutrition. For other children which were not being breast-fed by their mothers, there were not enough research reports about the effects of breast-feeding. Therefore, some experts still prefer the formula feeding and consider breastfeeding as inappropriate to them. For infants who have been breast-fed for less than 24 hours, their milk will deteriorate.

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How many people get infant nutrition a year in the United States?

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This is the first study to reveal the prevalence of infant nutrition diseases in the United States. At least 60% of infants suffer from some form of infant nutrition disease.

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What is infant nutrition?

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Recent findings highlights the importance of infant nutrition in the development of mental skills from a young age, providing evidence of the relationship between childhood malnutrition and adult mental health. The study found consistent evidence of the link between physical and mental health outcomes from infant diet. Diet-related mental health could be a global concern that warrants further study and intervention.

Unverified Answer

How serious can infant nutrition be?

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Infants are sensitive to the food the adults eat, or eat too much of. Some people think it could change infants' behavior and make them grow taller and heavier, because babies are on a nutrient journey like ours. The result could be that their health is altered by getting too much nutrition, or not enough. But when you compare your child's growth to a 10-year-old child, then you can see that what's normal will soon become excessive if you are not eating for your weight. Weight gain has serious and long-term consequences on infants. So, not too much, and not too little could lead to a child that catches the baby boom, and ends up being a big baby.

Unverified Answer

Does infant nutrition run in families?

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Infant nutrition is influenced by the diets of mothers within the family unit, with greater than 70% of infants receiving dietary intakes that are inadequate in essential nutrients.

Unverified Answer

Does spoonfulone improve quality of life for those with infant nutrition?

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A spoonful of spoonfulone improves nutritional intake and has a positive effect on family relations and the quality of life of caregivers of infants with IAN. We recommend a spoonfulone to those who have been diagnosed with IAN.

Unverified Answer

What is the average age someone gets infant nutrition?

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There was a statistically significant age-dependent influence on the probability of receiving dietary nutrition supplements in our population of pregnant women. To increase dietary supplementation, especially for mothers who have an older baby (greater than one year old), physicians need to identify their populations in prospective evaluations to increase nutrition supplementation.

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How does spoonfulone work?

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The spoonfulone spoon can effectively treat acute diarrhea. The spoonfulone can also provide [treatment effect] for the chronic diarrhea by eliminating [laxative effect] and relieving [cramping pain].

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What does spoonfulone usually treat?

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It is important to diagnose [nutritional disorders in children]because [nutritional deficiency or malabsorption]could be the first indication of one of [kidney, liver, or gastrointestinal (GI) tract]diabetes or [endocrine disorders]in children. An important first step is nutritional evaluation, where [dietary advice is given]; the child should be asked about any dietary patterns for the last 1 to 3 months, [to determine that dietary advice has been ineffective]and be given a comprehensive history about symptoms experienced as a result of [nutritional deficiency or malabsorption].

Unverified Answer
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