The Play With Me Study

NCT ID: NCT04280198

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2022-06-20

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.

Conditions

High Food Reinforcement; Overeating; Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Triple P Parenting Videos

Intervention Type: BEHAVIORAL

Four video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices.

Activity Boxes

Intervention Type: BEHAVIORAL

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.

Interventions

Triple P Parenting Videos

Four video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices.

Intervention Type: BEHAVIORAL

Activity Boxes

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Anzman-Frasca

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Anzman-Frasca, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

State University of New York at Buffalo

Buffalo, New York, United States

Countries

United States

Other Identifiers

STUDY00004200

Identifier Type: -

Identifier Source: org_study_id