- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280198
The Play With Me Study
Using Positive Parent-child Interactions as an Alternative Reinforcer to Promote Healthier Eating Among Young Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The modern environment is obesity-promoting, with easy access to palatable, energy-dense foods and appealing sedentary activities. Despite this overarching environment, some individuals are able to maintain a normal weight status, suggesting that there are individual differences in susceptibility to obesity-promoting environments. The RRV of food captures individual differences in the motivation to eat by measuring how hard individuals will work for access to food versus other activities, and it has been shown to predict weight outcomes among infants, children, and adults. In a pilot study with infants, Kong, Eiden, Epstein, et al. demonstrated support for this hypothesis as providing infants and parents with access to group music classes increased infants' reinforcing values of music relative to food. Compared to other age groups, less research has been conducted on the RRV of food in preschool children. Filling this gap in the literature is important, as the preschool period is a period of drastic transitions, including extensive learning of food preferences and habits. Studies have also shown that obesity during adolescence is more likely among children who are already overweight by age 5, further highlighting the importance of innovative approaches to childhood obesity prevention prior to school entry.
In the proposed study, we aim to bring together the literature on food reinforcement and the literature on parenting interventions in early childhood by promoting positive, rewarding parent-child interactions as a novel alternative reinforcer to decrease the RRV of food. Positive parenting can be defined as sensitive, responsive parenting, where parents' responses are appropriate for and contingent upon the child's cues and developmental level. This style of parenting early in life has been linked to positive cognitive and socio-emotional outcomes in adolescence and beyond. The focus of the present study is to assess the initial efficacy of the present parenting intervention, as well as its feasibility. This study will pave the way for future testing of this intervention's effects on the RRV of food and other positive developmental and health outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14214
- State University of New York at Buffalo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Child is 4-5 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 participation
- At least one of the child's parents/guardians are overweight/obese based on self-reported height and weight. This is intended to facilitate recruitment of children at risk for obesity, given the overarching goals of this research.
- Parent and child are English speaking
Exclusion Criteria:
- The child is outside the age range of 4-5 years
- Child is diagnosed with a serious physical or mental health condition that precludes participation
- Parent/guardian <18 years old
- None of the child's parents/legal guardians overweight/obese based on self-reported height and weight
- Parent or child not English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No Intervention: Group 1 - Control
Participants will attend three laboratory visits: baseline 1, baseline 2, and post-test.
At baseline 2 and post-test, the primary outcome of child RRV of food vs. parent child interaction is measured.
Other measures include child height and weight, child self-regulation, and parenting in the context of a parent-child interaction task.
Participants in the control group will not be assigned to complete any intervention activities during the 4-week intervention phase (which takes place between baseline 2 and post-test visits); however, they will receive contacts from a member of the lab each week in the form of electronic reminders (i.e.
texts) to remind them of their upcoming post-test laboratory appointment and will receive some intervention materials after the post-test assessment.
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Experimental: Experimental: Group 2 - Intervention
Participants will attend the same three laboratory visits as the control group.
The intervention group will also participate in a 4-week intervention, which consists of the parent watching brief weekly parenting videos from the online Triple P Parenting Program and completing interactive parent-child activities from activity boxes created by our laboratory (~60 min of interactive activities/week).
Participants will use their activity boxes to practice specific parenting skills from the week's parenting video.
Throughout the intervention phase, participants will receive regular text messages to remind them of the week's activities and ask several questions about engagement in study activities over the past 24 hours.
The intervention group will also complete an exit interview about the intervention following the post-test assessment to provide insights on fidelity and acceptability.
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Four video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices.
There will be about 4 planned activities per week within activity boxes provided to families.
The activities will be a context in which the positive parenting behaviors can be practiced.
Each activity will take about 15 minutes.
Families can pick each week whether they'd like their parenting practice to be embedded in reading activities, nature walks/active games, or arts and crafts.
Instructions will be included with each activity, including prompts to allow the parent to apply learnings from that week's parenting video and to allow interactions to be child-led.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child's relative reinforcing value of food versus parent-child interaction
Time Frame: Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 6 (post-test)
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Change in child's relative reinforcing value of food versus parent-child interaction
Time Frame: Week 2 (baseline), Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 2 (baseline), Week 6 (post-test)
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Child's maximum schedule reached for food (food reinforcement)
Time Frame: Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 6 (post-test)
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Change in child's maximum schedule reached for food (food reinforcement)
Time Frame: Week 2 (baseline), Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 2 (baseline), Week 6 (post-test)
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Child's maximum schedule reached for parent-child interaction
Time Frame: Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 6 (post-test)
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Change in child's maximum schedule reached for parent-child interaction
Time Frame: Week 2 (baseline), Week 6 (post-test)
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Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent
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Week 2 (baseline), Week 6 (post-test)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Observations of warm and sensitive parenting
Time Frame: Week 6 (post-test)
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Coded from parent-child interaction using Iowa Family Interaction Rating Scales.
The score will be a composite of the following scales, following work by Eiden and colleagues: positive reinforcement, encourages independence, sensitive child-centered, positive mood, warmth/support, prosocial, communication, listener response, relationship quality, rater response.
We will also examine relationships between the scales to examine whether the composite is appropriate.
Range: 1-9, 9=more warmth/sensitive parenting
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Week 6 (post-test)
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Observations of child prosocial behavior
Time Frame: Week 6 (post-test)
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Coded from parent-child interaction using Iowa Family Interaction Rating Scales.
Scale: child prosocial behavior.
Range: 1-9, 9=more prosocial behavior
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Week 6 (post-test)
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Parent-reported nurturance in parenting
Time Frame: Week 6 (post-test)
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Comprehensive General Parenting Questionnaire.
Range: 1-5, 5=more nurturance
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Week 6 (post-test)
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Parent-reported structure in parenting
Time Frame: Week 6 (post-test)
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Comprehensive General Parenting Questionnaire.
Range: 1-5, 5=more structure
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Week 6 (post-test)
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Parent-reported nurturance in parenting
Time Frame: Week 10 (follow-up)
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Comprehensive General Parenting Questionnaire.
Range: 1-5, 5=more nurturance
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Week 10 (follow-up)
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Parent-reported structure in parenting
Time Frame: Week 10 (follow-up)
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Comprehensive General Parenting Questionnaire.
Range: 1-5, 5=more structure
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Week 10 (follow-up)
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Parent-reported parenting efficacy
Time Frame: Week 6 (post-test)
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Parenting Sense of Competence Questionnaire.
Range: 1-6, 6=more efficacy
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Week 6 (post-test)
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Parent-reported parenting efficacy
Time Frame: Week 10 (follow-up)
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Parenting Sense of Competence Questionnaire.
Range: 1-6, 6=more efficacy
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Week 10 (follow-up)
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Parent-reported parenting satisfaction
Time Frame: Week 6 (post-test)
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Parenting Sense of Competence Questionnaire.
Range: 1-6, 6=more satisfaction
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Week 6 (post-test)
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Parent-reported parenting satisfaction
Time Frame: Week 10 (follow-up)
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Parenting Sense of Competence Questionnaire.
Range: 1-6, 6=more satisfaction
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Week 10 (follow-up)
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Child self-regulation
Time Frame: Week 6 (post-test)
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Head Toes Knees Shoulders Task
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Week 6 (post-test)
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Child total behavioral difficulties
Time Frame: Week 6 (post-test)
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Strengths and difficulties questionnaire.
Range=0-40, 40=more difficulties
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Week 6 (post-test)
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Child overall behavioral difficulties
Time Frame: Week 10 (follow-up)
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Strengths and difficulties questionnaire.
Range=0-40, 40=more difficulties
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Week 10 (follow-up)
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Child prosocial behavior
Time Frame: Week 6 (post-test)
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Strengths and difficulties questionnaire.
Range=0-10, 10=more prosocial behavior
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Week 6 (post-test)
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Child prosocial behavior
Time Frame: Week 10 (follow-up)
|
Strengths and difficulties questionnaire.
Range=0-10, 10=more prosocial behavior
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Week 10 (follow-up)
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Child peer relationships problems
Time Frame: Week 6 (post-test)
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Strengths and difficulties questionnaire.
Range=0-10, 10=more peer problems
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Week 6 (post-test)
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Child peer relationships problems
Time Frame: Week 10 (follow-up)
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Strengths and difficulties questionnaire.
Range=0-10, 10=more peer problems
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Week 10 (follow-up)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intervention compliance
Time Frame: Week 2-5
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Daily text messages (intervention group only)
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Week 2-5
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Intervention acceptability
Time Frame: Week 2-5
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Daily text messages (intervention group only)
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Week 2-5
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Intervention acceptability
Time Frame: Week 6 (post-test)
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Exit interview (intervention group only)
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Week 6 (post-test)
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Intervention use and acceptability
Time Frame: Week 10 (follow-up)
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Parent questionnaire
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Week 10 (follow-up)
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Collaborators and Investigators
Investigators
- Principal Investigator: Stephanie Anzman-Frasca, PhD, State University of New York at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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