NCT06074926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

October 3, 2023

Last Update Submit

August 26, 2024

Conditions

Keywords

Repeated ExposureAssociative ConditioningPositive ParentingFood AcceptanceDiet Quality

Outcome Measures

Primary Outcomes (4)

  • Child's target vegetable preference

    Ranked ordered preference overall (range 1-7, 7 = least preferred) and relative to control vegetable

    Week 5 (post-test)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • Reported general parenting

    Week 5 (post-test)

  • Observed general parenting

    Week 5 (post-test)

  • Observed child affect/behavior

    Week 5 (post-test)

Other Outcomes (2)

  • Frequency of vegetables consumed by child (past week)

    Week 4 (intervention period)

  • Variety of vegetables consumed by child (past week)

    Week 4 (intervention period)

Study Arms (2)

Group 1 - Intervention

EXPERIMENTAL

Participants will attend two laboratory visits and complete a 3-week intervention, which consists of interactive parent-child activities (\~45 min of interactive activities/week) that pair tasting an assigned target vegetable with positive parent-child interactions. Positive interactions will be promoted via positive parenting prompts embedded in the activity instructions (e.g., prompts promoting child-directed play).

Behavioral: Associative Conditioning

Group 2 - Control

EXPERIMENTAL

Participants will attend the same two laboratory visits and complete a 3-week intervention, which consists of only individual taste exposures to their target vegetable.

Behavioral: Repeated Exposure

Interventions

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.

Group 1 - Intervention

There will be 3 planned exposures per week (9 total). Exposures will include only individual tastes of the child's assigned target vegetable.

Group 2 - Control

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Pediatric ObesityOvernutrition

Condition Hierarchy (Ancestors)

ObesityOverweightNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie Anzman-Frasca, PhD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Membership in the "intervention" versus "control" group will not be discussed as such, but participants will know whether they receive the repeated exposure (control group) or associative conditioning (intervention group) activities.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

October 30, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations