Food PreferencesNCT04544332
The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
An observational study of Food Preferences and Parenting, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Nutrition supplements have tremendous impact upon the nutritional and developmental status of malnourished children. These products have been designed to be acceptable to children (often by adding nutritive sweeteners to make them more palatable), but to date there has been little rigorous testing of their… Read more about this study
- Who is it for?
- Ages 7 to 24 months
- Conditions the study is for
- Food Preferences, Parenting
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 24 months
- All sexes
- Child
Study population: Infants and toddlers and their caregivers will be recruited for this study via: * printed advertisements placed in a number of community and healthcare venues and posted on online websites. * emails sent through the university * referrals from other participating caregivers
Who may be able to join
- Term birth (at least 37 weeks gestation)
- Experience with complementary foods
- Previous exposure to nuts (butters, powders, or other nut ingredients)
- Caregiver at least 18 years of age and < 51 years of age
- Caregiver lives within 75 miles of the University of Colorado Anschutz Medical Campus
- Caregiver must feed the infant or toddler at least 50% of the time
Who cannot join
- Has a genetic disorder or developmental disability, as these conditions often result in feeding difficulties
- Has a reported illness or metabolic disorder (e.g., food allergy) that could affect food intake
- Was born prematurely (< 37 weeks gestation)
- Caregiver is less than 18 years of age
- Caregiver lives more than 75 miles from the University of Colorado Anschutz Medical Campus
- Caregiver does not read and speak English
- Caregiver has a food allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Nutrition supplements have tremendous impact upon the nutritional and developmental status of malnourished children. These products have been designed to be acceptable to children (often by adding nutritive sweeteners to make them more palatable), but to date there has been little rigorous testing of their palatability for infants, toddlers and young children. The overall goal of this project is to investigate whether:
- children's acceptance of a nutrition supplement is associated with maternal persistence in offering the food to her child over a 2-week period;
- an unsweetened version of the nutrition supplement differs in short- and long-term acceptance; and
- maternal liking of the supplement is associated with her persistence in offering the food to her child.
Read the detailed description
More rigorous pre-testing of nutrition supplements, with a focus on palatability (i.e., observations of behavioral and facial responses to its taste) and its relation to children's acceptance (defined here as consumption), could provide important insights into the capacity for these products to transition from being perceived as "medicine" to being accepted as "food," or part of the usual child diet. A clearer understanding of the relation between observed child indicators of palatability and acceptance, both initially and over time (i.e., repeated exposure effects), is important for predicting the longer-term impacts on children's dietary intake, growth and health. Further, a better grasp of caregiver perceptions of the acceptability of these products, both their child's and their own, is critical in paving the way for overcoming barriers and identifying facilitators associated with longer-term acceptance of these nutritional supplements.
We secondarily will also explore the effects of potential mediators on caregiver persistence and infant acceptance of a sweetened and an unsweetened small-quantity lipid nutrition supplement (SQ-LNS) such as:
- Maternal feeding self-efficacy
- Caregiver food neophobia
- Caregiver feeding styles using the Infant Feeding Style Questionnaire
- Infant feeding history and food experience
- Toddler eating behaviors using the Child Eating Behavior Questionnaire for Toddlers
- Infant behaviors using the Infant Behavior Questionnaire-Revised (Garstein \& Rothbart 2003 Inf Behav Dev)
- Conditions
- Food Preferences, Parenting
- Keywords
- Infant Feeding, Toddler Feeding, Food Acceptance, Food Parenting
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unsweetened Supplement | Infants will receive 10 exposures to the unsweetened small quantity lipid nutritional supplement (SQ-LNS) at home | |
| Sweetened Supplement | Infants will receive 10 exposures to the sweetened small quantity lipid nutritional supplement (SQ-LNS) at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of infant acceptance of sweetened and unsweetened nutritional supplement
Acceptance is measured at the conclusion of each offered bite using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS) on a 4-point scale from 0-3 where 0 = refusal and 3 = early acceptance of food
Measured: Baseline, Week 2
Change in infant consumption of sweetened and unsweetened nutritional supplement
Consumption of each type of supplement will be measured in grams. The weight of the remainder of each supplement will be subtracted from the initial weight of the supplement prior to offering. The remainder of the supplements offered at home will be frozen and returned to the lab to be weighed.
Measured: Baseline up to Week 2
Secondary outcomes (4)
Baseline caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
After feeding each version of the supplement, the caregiver will be instructed to rate how much he/she thought his/her infant liked the supplement by placing a mark on a 100 mm visual analog scale (VAS) ranging from "dislikes extremely" to "likes extremely". The distance of the caregivers' marking on the 100mm line is measured from "dislikes extremely" in mm, with higher measurement values meaning caregivers perceive the infants like the supplement more.
Measured: Baseline
Follow up caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
After feeding each version of the supplement, the caregiver will be instructed to rate how much he/she thought his/her infant liked the supplement by placing a mark on a 100 mm visual analog scale (VAS) ranging from "dislikes extremely" to "likes extremely". The distance of the caregivers' marking on the 100mm line is measured from "dislikes extremely" in mm, with higher measurement values meaning caregivers perceive the infants like the supplement more.
Measured: Visit two: change from baseline caregivers' perceived ratings at two weeks
Baseline caregivers' perceived acceptability of the sweetened and unsweetened supplements
After feeding each version of the supplement, the caregiver will be instructed to rate how likely they would be to serve each supplement again by placing a mark on a 100 mm visual analog scale (VAS) ranging from "not at all likely" to "extremely likely". The distance of the caregivers' marking on the 100mm line is measured from "not at all likely" in mm, with higher measurement values meaning caregivers are more likely to serve the supplement again.
Measured: Baseline
Follow up caregivers' perceived acceptability of the sweetened and unsweetened supplements
After feeding each version of the supplement, the caregiver will be instructed to rate how likely they would be to serve each supplement again by placing a mark on a 100 mm visual analog scale (VAS) ranging from "not at all likely" to "extremely likely". The distance of the caregivers' marking on the 100mm line is measured from "not at all likely" in mm, with higher measurement values meaning caregivers are more likely to serve the supplement again.
Measured: Visit two: change from baseline caregivers' acceptability ratings at two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start25 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Food PreferencesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Global Alliance for Improved Nutrition, Purdue University
- Responsible party
- Sponsor
- Investigators
- Susan L Johnson, PhD, Principal investigator, University of Colorado, DenverMatthew Greenhawt, MD, Principal investigator, University of Colorado, DenverJennifer O Fisher, PhD, Principal investigator, Temple UniversityKameron J Moding, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544332
- Sponsor's protocol ID
- 17-2308
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available upon request to the Principal Investigator (SL Johnson)
Publications
Thompson AL, Mendez MA, Borja JB, Adair LS, Zimmer CR, Bentley ME. Development and validation of the Infant Feeding Style Questionnaire. Appetite. 2009 Oct;53(2):210-21. doi: 10.1016/j.appet.2009.06.010. Epub 2009 Jul 1.
PubMed 19576254Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.
PubMed 11693591Johnson SL, Shapiro ALB, Moding KJ, Flesher A, Davis K, Fisher JO. Infant and Toddler Consumption of Sweetened and Unsweetened Lipid Nutrient Supplements After 2-Week Home Repeated Exposures. J Nutr. 2021 Sep 4;151(9):2825-2834. doi: 10.1093/jn/nxab148.
PubMed 34036363
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
- ClinicalTrials.gov ID
- NCT04544332
- Acronym / sponsor ID
- 17-2308
- Conditions
- Food Preferences, Parenting
- Keywords
- Infant Feeding, Toddler Feeding, Food Acceptance, Food Parenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Temple University, Global Alliance for Improved Nutrition, Purdue University
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition supplements have tremendous impact upon the nutritional and developmental status of malnourished children. These products have been designed to be acceptable to children (often by adding nutritive sweeteners to make them more palatable), but to date there has been little rigorous testing of their palatability for infants, toddlers and young children. The overall goal of this project is to investigate whether:
- children's acceptance of a nutrition supplement is associated with maternal persistence in offering the food to her child over a 2-week period;
- an unsweetened version of the nutrition supplement differs in short- and long-term acceptance; and
- maternal liking of the supplement is associated with her persistence in offering the food to her child.
Detailed description
More rigorous pre-testing of nutrition supplements, with a focus on palatability (i.e., observations of behavioral and facial responses to its taste) and its relation to children's acceptance (defined here as consumption), could provide important insights into the capacity for these products to transition from being perceived as "medicine" to being accepted as "food," or part of the usual child diet. A clearer understanding of the relation between observed child indicators of palatability and acceptance, both initially and over time (i.e., repeated exposure effects), is important for predicting the longer-term impacts on children's dietary intake, growth and health. Further, a better grasp of caregiver perceptions of the acceptability of these products, both their child's and their own, is critical in paving the way for overcoming barriers and identifying facilitators associated with longer-term acceptance of these nutritional supplements.
We secondarily will also explore the effects of potential mediators on caregiver persistence and infant acceptance of a sweetened and an unsweetened small-quantity lipid nutrition supplement (SQ-LNS) such as:
- Maternal feeding self-efficacy
- Caregiver food neophobia
- Caregiver feeding styles using the Infant Feeding Style Questionnaire
- Infant feeding history and food experience
- Toddler eating behaviors using the Child Eating Behavior Questionnaire for Toddlers
- Infant behaviors using the Infant Behavior Questionnaire-Revised (Garstein \& Rothbart 2003 Inf Behav Dev)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unsweetened Supplement | – | –Infants will receive 10 exposures to the unsweetened small quantity lipid nutritional supplement (SQ-LNS) at home |
| Sweetened Supplement | – | –Infants will receive 10 exposures to the sweetened small quantity lipid nutritional supplement (SQ-LNS) at home |
Who may qualify
- Ages
- 7 to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Infants and toddlers and their caregivers will be recruited for this study via: * printed advertisements placed in a number of community and healthcare venues and posted on online websites. * emails sent through the university * referrals from other participating caregivers
Key inclusion criteria (6 listed)
- Term birth (at least 37 weeks gestation)
- Experience with complementary foods
- Previous exposure to nuts (butters, powders, or other nut ingredients)
- Caregiver at least 18 years of age and < 51 years of age
- Caregiver lives within 75 miles of the University of Colorado Anschutz Medical Campus
Key exclusion criteria (7 listed)
- Has a genetic disorder or developmental disability, as these conditions often result in feeding difficulties
- Has a reported illness or metabolic disorder (e.g., food allergy) that could affect food intake
- Was born prematurely (< 37 weeks gestation)
- Caregiver is less than 18 years of age
- Caregiver lives more than 75 miles from the University of Colorado Anschutz Medical Campus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in rate of infant acceptance of sweetened and unsweetened nutritional supplement
Time frame: Baseline, Week 2
Acceptance is measured at the conclusion of each offered bite using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS) on a 4-point scale from 0-3 where 0 = refusal and 3 = early acceptance of food
Change in infant consumption of sweetened and unsweetened nutritional supplement
Time frame: Baseline up to Week 2
Consumption of each type of supplement will be measured in grams. The weight of the remainder of each supplement will be subtracted from the initial weight of the supplement prior to offering. The remainder of the supplements offered at home will be frozen and returned to the lab to be weighed.
4 secondary outcomes
Baseline caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
Time frame: Baseline
Follow up caregivers' perceived ratings of infant liking of sweetened and unsweetened supplements
Time frame: Visit two: change from baseline caregivers' perceived ratings at two weeks
Baseline caregivers' perceived acceptability of the sweetened and unsweetened supplements
Time frame: Baseline
Follow up caregivers' perceived acceptability of the sweetened and unsweetened supplements
Time frame: Visit two: change from baseline caregivers' acceptability ratings at two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Background: PubMed 19576254Thompson AL, Mendez MA, Borja JB, Adair LS, Zimmer CR, Bentley ME. Development and validation of the Infant Feeding Style Questionnaire. Appetite. 2009 Oct;53(2):210-21. doi: 10.1016/j.appet.2009.06.010. Epub 2009 Jul 1.
- Background: PubMed 11693591Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.
- Derived from this study: PubMed 34036363Johnson SL, Shapiro ALB, Moding KJ, Flesher A, Davis K, Fisher JO. Infant and Toddler Consumption of Sweetened and Unsweetened Lipid Nutrient Supplements After 2-Week Home Repeated Exposures. J Nutr. 2021 Sep 4;151(9):2825-2834. doi: 10.1093/jn/nxab148.
- Individual participant dataSharing planned: Undecided. Data may be available upon request to the Principal Investigator (SL Johnson)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L Johnson, PhD principal investigator
University of Colorado, Denver
Matthew Greenhawt, MD principal investigator
University of Colorado, Denver
Jennifer O Fisher, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Preferences and Parenting, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rate of infant acceptance of sweetened and unsweetened nutritional supplement (time frame: Baseline, Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04544332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.