Parenting Clinical Trial
Official title:
The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
NCT number | NCT04544332 |
Other study ID # | 17-2308 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 25, 2018 |
Est. completion date | April 1, 2019 |
Verified date | September 2020 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. children's acceptance of a nutrition supplement is associated with maternal persistence
in offering the food to her child over a 2-week period;
2. an unsweetened version of the nutrition supplement differs in short- and long-term
acceptance; and
3. maternal liking of the supplement is associated with her persistence in offering the
food to her child.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 7 Months to 24 Months |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Global Alliance for Improved Nutrition, Purdue University, Temple University |
United States,
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. — View Citation
Wardle 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline, Week 2 | |
Primary | 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. | Baseline up to Week 2 | |
Secondary | 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. | Baseline | |
Secondary | 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. | Visit two: change from baseline caregivers' perceived ratings at two weeks | |
Secondary | 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. | Baseline | |
Secondary | 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. | Visit two: change from baseline caregivers' acceptability ratings at two weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03905278 -
Parental Support Intervention in the Oncological Context
|
N/A | |
Recruiting |
NCT06111040 -
Nurturing Needs Study: Parenting Food Motivated Children
|
N/A | |
Completed |
NCT03559907 -
Partnering for Prevention: Building Healthy Habits in Underserved Communities
|
N/A | |
Completed |
NCT04628546 -
The Parenting Young Children Check-up Evaluation
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Terminated |
NCT03517111 -
The Impact of a Parenting Intervention on Latino Youth Health Behaviors
|
N/A | |
Completed |
NCT04502979 -
Learning to Love Mealtime Together
|
N/A | |
Completed |
NCT03097991 -
Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)
|
N/A | |
Recruiting |
NCT06038721 -
Unified Protocol: Community Connections
|
N/A | |
Completed |
NCT04556331 -
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds
|
N/A | |
Completed |
NCT04101799 -
Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden
|
N/A | |
Completed |
NCT02792309 -
Impact Evaluation of MotherWise Program
|
N/A | |
Recruiting |
NCT02622048 -
Understanding and Helping Families: Parents With Psychosis
|
N/A | |
Completed |
NCT02718508 -
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use
|
N/A | |
Completed |
NCT01861158 -
Online Parent Training for Children With Behavior Disorders
|
N/A | |
Completed |
NCT01554215 -
Mom Power is an Attachment Based Parenting Program for Families and Their Children
|
Phase 2 | |
Terminated |
NCT01395238 -
Enhancing Father's Ability to Support Their Preschool Child
|
N/A | |
Completed |
NCT05930535 -
Family-Focused Adolescent & Lifelong Health Promotion
|
N/A | |
Completed |
NCT04525703 -
Pathways for Parents After Incarceration Feasibility Study
|
N/A | |
Recruiting |
NCT06038799 -
Caregiver Skills Training: Comparing Clinician Training Methods
|
N/A |