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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06074926
Other study ID # STUDY00007145
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date May 1, 2024

Study information

Verified date January 2024
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Approximately one half of adults and one-fifth of children have obesity, including 14% of 2-5-year-olds. Early obesity prevention is essential as children who are overweight by age 5 are at increased risk for later obesity. Dietary intake is inextricably linked to weight status, and the majority of young children fail to meet intake recommendations, with socioeconomically disadvantaged and racial/ethnic minority children at increased risk of poor diet quality. However, children's liking of healthier foods predicts their intake, and children can learn to like healthier foods via experience. The current study brings together evidence from the parenting and learning literatures to: 1) examine effects of a novel learning strategy leveraging positive parent-child interactions on 3-5-year-old children's vegetable acceptance and dietary intake, as well as to explore 2) individual differences in learning strategy effects.


Description:

Repeated exposure, in which children taste a target food across several occasions, is an effective strategy for increasing children's acceptance and intake of healthier foods. An alternative strategy that may be preferable for those less likely to try unfamiliar or disliked foods is associative conditioning. This refers to changes in one's response to a target food after it is repeatedly, concurrently paired with an unconditioned stimulus - typically another food - that already has a positive valence. While evidence-based, this approach has the disadvantage of adding extra calories and exposure to less healthy foods. Pilot data provided support for the hypothesis that non-food stimuli could be leveraged in conditioning strategies to promote healthier food acceptance. After pairing positive peer interactions (via group games) with tasting a target vegetable across 11 sessions, 6-8-year-old children's preferences for target vegetables increased at post-test. In considering application of this approach for younger children, positive parent-child interactions may be an appropriate non-food stimulus as parents are a primary social influence for this age group. Despite this, no studies to date have leveraged this positive stimulus in the context of associative conditioning paradigms designed to promote vegetable acceptance. Additionally, although other food preference learning approaches, like repeated exposure, are well-established in the experimental literature, less is known regarding individual differences impacting intervention effectiveness. The current study seeks to examine effects of a novel learning strategy leveraging positive parent-child interactions on 3-5-year-old children's vegetable acceptance and dietary intake, as well as to explore individual differences in learning strategy effects. Findings will inform future intervention work, as well as offer insight into potential behavioral factors influencing young children's diet and health.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - Child is 3-5 years old - Parent/ guardian is 18 years of age or older - Child is not diagnosed with a serious physical or mental health condition that precludes safe participation - Parent and child are English speaking Exclusion Criteria: - The child is outside the age range of 3-5 years - Child is diagnosed with a serious physical or mental health condition that precludes participation - Parent/ guardian is less than 18 years of age

Study Design


Intervention

Behavioral:
Associative Conditioning
There will be 3 planned activities per week (9 total) within play kits provided to families. Children will first taste their assigned target vegetable and then complete an activity with their parent following provided instructions. Activity instructions will include positive parenting skills adapted from evidence-based parenting programs (i.e., Parent-Child Interaction Therapy (PCIT) and Triple-P) designed to promote positive parent-child interactions.
Repeated Exposure
There will be 3 planned exposures per week (9 total). Exposures will include only individual tastes of the child's assigned target vegetable.

Locations

Country Name City State
United States State University of New York at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Frequency of vegetables consumed by child (past week) Parents will report on how often their child consumed vegetables during week 4 (intervention period) via the EPOCH Preschooler Dietary Questionnaire (range: 0 to "more than once per day") Week 4 (intervention period)
Other Variety of vegetables consumed by child (past week) Parents will report which of 26 possible types of vegetables their child consumed during week 4 (intervention period) via the EPOCH Preschooler Dietary Questionnaire (range: 0 to 26) Week 4 (intervention period)
Primary Child's target vegetable preference Ranked ordered preference overall (range 1-7, 7 = least preferred) and relative to control vegetable Week 5 (post-test)
Primary Child's target vegetable liking Child-reported liking (3-point visual face scale (e.g., yummy, yucky, just OK) adapted from Birch and colleagues) overall and relative to control vegetable Week 5 (post-test)
Primary Child's willingness to taste target vegetable Observed by study staff, defined as child placing vegetable in his/her mouth (i.e., eating the vegetable or spitting it out) Week 5 (post-test)
Primary Child target vegetable ad libitum consumption 10-minute period where child can eat as much or as little of provided foods (7 study vegetables + a neutral snack food (i.e., cracker)). Consumption will be measured via plate waste and overall consumption (grams) of the target vegetable, as well as consumption relative to the a) control vegetable and b) neutral snack will be calculated Week 5 (post-test)
Secondary Reported general parenting Parents will complete the Comprehensive General Parenting Questionnaire (CGPQ; items rated from 1 (strongly disagree) - 5 (strongly agree), higher scores reflect higher level of parenting dimension of interest) to assess 5 dimension of general parenting (sensitivity/nurturance, structure, overprotection, coercive control, behavioral control) Week 5 (post-test)
Secondary Observed general parenting Observations of parenting will be coded from an 8-minute interactive play activity using the Iowa Family Interaction Rating Scales (IFIRS; ratings range from 1-9, 9=higher levels of behavior of interest). Aspects of parenting examined include: positive mood, warmth/support, physical affection, communication, listener responsiveness, prosocial behavior, encourages independence, intrusiveness, positive reinforcement, sensitive/child-centered, relationship quality Week 5 (post-test)
Secondary Observed child affect/behavior Observations of child affect/behavior will be coded from an 8-minute interactive play activity with a parent using the IFIRS Scales (described previously). Aspects of child affect/behavior examined include: positive mood, prosocial behavior, antisocial (i.e., externalizing) behavior Week 5 (post-test)
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