Clinical trial NCT04280198: The Play With Me Study
Official title: Using Positive Parent-child Interactions as an Alternative Reinforcer to Promote Healthier Eating Among Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Food Reinforcement
Overeating
Obesity, Childhood
Keywords: relative reinforcing value of food
food reinforcement
positive parenting
parenting intervention
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The obesity epidemic continues to be a major public health concern, with 38% of US adults and 17% of children obese. One factor that has been highlighted as a robust predictor of weight outcomes is the relative reinforcing value (RRV) of food, or how rewarding one finds eating compared to alternative activities. An emerging body of literature has built upon the observed relationship between the RRV of food and weight by hypothesizing that the promotion of alternative reinforcers, or rewarding activities that could take the place of eating, offers a novel approach to decreasing excess energy intake and combatting obesity. We aim to integrate distinct bodies of literature and fill a gap in the evidence by testing whether parenting intervention messages delivered and practiced in the context of shared activities can decrease the RRV of food by making parent-child interactions more rewarding. The ultimate goal of this research is to demonstrate that such an intervention can increase children's motivation to interact with their parent instead of eating a favorite food, demonstrating the potential for positive parent-child interactions to become an alternative source of pleasure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child's relative reinforcing value of food versus parent-child interaction
timeFrame: Week 6 (post-test)
measure: Change in child's relative reinforcing value of food versus parent-child interaction
timeFrame: Week 2 (baseline), Week 6 (post-test)
measure: Child's maximum schedule reached for food (food reinforcement)
timeFrame: Week 6 (post-test)
measure: Change in child's maximum schedule reached for food (food reinforcement)
timeFrame: Week 2 (baseline), Week 6 (post-test)
measure: Child's maximum schedule reached for parent-child interaction
timeFrame: Week 6 (post-test)
measure: Change in child's maximum schedule reached for parent-child interaction
timeFrame: Week 2 (baseline), Week 6 (post-test)
Secondary outcomes:
measure: Observations of warm and sensitive parenting
timeFrame: Week 6 (post-test)
measure: Observations of child prosocial behavior
timeFrame: Week 6 (post-test)
measure: Parent-reported nurturance in parenting
timeFrame: Week 6 (post-test)
measure: Parent-reported structure in parenting
timeFrame: Week 6 (post-test)
measure: Parent-reported nurturance in parenting
timeFrame: Week 10 (follow-up)
measure: Parent-reported structure in parenting
timeFrame: Week 10 (follow-up)
measure: Parent-reported parenting efficacy
timeFrame: Week 6 (post-test)
measure: Parent-reported parenting efficacy
timeFrame: Week 10 (follow-up)
measure: Parent-reported parenting satisfaction
timeFrame: Week 6 (post-test)
measure: Parent-reported parenting satisfaction
timeFrame: Week 10 (follow-up)
measure: Child self-regulation
timeFrame: Week 6 (post-test)
measure: Child total behavioral difficulties
timeFrame: Week 6 (post-test)
measure: Child overall behavioral difficulties
timeFrame: Week 10 (follow-up)
measure: Child prosocial behavior
timeFrame: Week 6 (post-test)
measure: Child prosocial behavior
timeFrame: Week 10 (follow-up)
measure: Child peer relationships problems
timeFrame: Week 6 (post-test)
measure: Child peer relationships problems
timeFrame: Week 10 (follow-up)
Other outcomes:
measure: Intervention compliance
timeFrame: Week 2-5
measure: Intervention acceptability
timeFrame: Week 2-5
measure: Intervention acceptability
timeFrame: Week 6 (post-test)
measure: Intervention use and acceptability
timeFrame: Week 10 (follow-up)
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Stephanie Anzman-Frasca, PhD
role: PRINCIPAL_INVESTIGATOR
References: