Obesity, ChildhoodNCT06074926
Promoting Food Acceptance Through Positive Parenting: the Play and Grow Study
A study testing Associative Conditioning and Repeated Exposure in people with Obesity, Childhood and Overweight, Childhood, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Overweight, Childhood, Overnutrition
- What is being tested?
- Associative Conditioning and Repeated Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 1 Aug 2024
- Phase
- Interventional
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14214
About this study
Official title: Promoting Healthier Food Acceptance and Intake Among Young Children Using a Novel Positive Parent-Child Interaction Strategy
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.
Read the detailed 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.
- Conditions
- Obesity, Childhood, Overweight, Childhood, Overnutrition, Pediatric Obesity, Eating, Healthy
- Being tested
- Associative Conditioning, Repeated Exposure
- Keywords
- Repeated Exposure, Associative Conditioning, Positive Parenting, Food Acceptance, Diet Quality
- Medical subject headings
- Pediatric Obesity, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Associative ConditioningBehavioural
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 ExposureBehavioural
There will be 3 planned exposures per week (9 total). Exposures will include only individual tastes of the child's assigned target vegetable.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Repeated Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's target vegetable preference
Ranked ordered preference overall (range 1-7, 7 = least preferred) and relative to control vegetable
Measured: 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
Measured: 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)
Measured: 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
Measured: Week 5 (post-test)
Secondary outcomes (3)
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)
Measured: Week 5 (post-test)
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
Measured: Week 5 (post-test)
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
Measured: Week 5 (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Oct 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Anzman-Frasca, State University of New York at Buffalo
- Investigators
- Stephanie Anzman-Frasca, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074926
- Sponsor's protocol ID
- STUDY00007145
- Status last verified
- Aug 2024
- First submitted
- 3 Oct 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthier Food Acceptance and Intake Among Young Children Using a Novel Positive Parent-Child Interaction Strategy
- ClinicalTrials.gov ID
- NCT06074926
- Acronym / sponsor ID
- STUDY00007145
- Conditions
- Obesity, Childhood, Overweight, Childhood, Overnutrition, Pediatric Obesity, Eating, Healthy
- Keywords
- Repeated Exposure, Associative Conditioning, Positive Parenting, Food Acceptance, Diet Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 10 Oct 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Intervention | Experimental | Behavioral: Associative ConditioningParticipants 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). |
| Group 2 - Control | Experimental | Behavioral: Repeated ExposureParticipants will attend the same two laboratory visits and complete a 3-week intervention, which consists of only individual taste exposures to their target vegetable. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Associative ConditioningThere 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. | Behavioural | Group 1 - Intervention |
| Repeated ExposureThere will be 3 planned exposures per week (9 total). Exposures will include only individual tastes of the child's assigned target vegetable. | Behavioural | Group 2 - Control |
Primary outcome
Child's target vegetable preference
Time frame: Week 5 (post-test)
Ranked ordered preference overall (range 1-7, 7 = least preferred) and relative to control vegetable
Child's target vegetable liking
Time frame: Week 5 (post-test)
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
Child's willingness to taste target vegetable
Time frame: Week 5 (post-test)
Observed by study staff, defined as child placing vegetable in his/her mouth (i.e., eating the vegetable or spitting it out)
Child target vegetable ad libitum consumption
Time frame: Week 5 (post-test)
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
3 secondary outcomes
Reported general parenting
Time frame: Week 5 (post-test)
Observed general parenting
Time frame: Week 5 (post-test)
Observed child affect/behavior
Time frame: Week 5 (post-test)
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 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Stephanie Anzman-Frasca, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Associative Conditioning and Repeated Exposure in people with Obesity, Childhood and Overweight, Childhood, run by State University of New York at Buffalo 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 4 inclusion and 3 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 27 Aug 2024. 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?
Child's target vegetable preference (time frame: Week 5 (post-test)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.