The Play With Me Study

Obesity, Childhood Clinical Trial

Official title:

Using Positive Parent-child Interactions as an Alternative Reinforcer to Promote Healthier Eating Among Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280198
• Other study ID #: STUDY00004200
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: August 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 20, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• High Food Reinforcement
• Hyperphagia
• Obesity, Childhood
• Overeating
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
United States	State University of New York at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention compliance	Daily text messages (intervention group only)	Week 2-5
Other	Intervention acceptability	Daily text messages (intervention group only)	Week 2-5
Other	Intervention acceptability	Exit interview (intervention group only)	Week 6 (post-test)
Other	Intervention use and acceptability	Parent questionnaire	Week 10 (follow-up)
Primary	Child's relative reinforcing value of food versus parent-child interaction	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 6 (post-test)
Primary	Change in child's relative reinforcing value of food versus parent-child interaction	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 2 (baseline), Week 6 (post-test)
Primary	Child's maximum schedule reached for food (food reinforcement)	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 6 (post-test)
Primary	Change in child's maximum schedule reached for food (food reinforcement)	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 2 (baseline), Week 6 (post-test)
Primary	Child's maximum schedule reached for parent-child interaction	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 6 (post-test)
Primary	Change in child's maximum schedule reached for parent-child interaction	Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent	Week 2 (baseline), Week 6 (post-test)
Secondary	Observations of warm and sensitive parenting	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	Week 6 (post-test)
Secondary	Observations of child prosocial behavior	Coded from parent-child interaction using Iowa Family Interaction Rating Scales. Scale: child prosocial behavior. Range: 1-9, 9=more prosocial behavior	Week 6 (post-test)
Secondary	Parent-reported nurturance in parenting	Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance	Week 6 (post-test)
Secondary	Parent-reported structure in parenting	Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure	Week 6 (post-test)
Secondary	Parent-reported nurturance in parenting	Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance	Week 10 (follow-up)
Secondary	Parent-reported structure in parenting	Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure	Week 10 (follow-up)
Secondary	Parent-reported parenting efficacy	Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy	Week 6 (post-test)
Secondary	Parent-reported parenting efficacy	Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy	Week 10 (follow-up)
Secondary	Parent-reported parenting satisfaction	Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction	Week 6 (post-test)
Secondary	Parent-reported parenting satisfaction	Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction	Week 10 (follow-up)
Secondary	Child self-regulation	Head Toes Knees Shoulders Task	Week 6 (post-test)
Secondary	Child total behavioral difficulties	Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties	Week 6 (post-test)
Secondary	Child overall behavioral difficulties	Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties	Week 10 (follow-up)
Secondary	Child prosocial behavior	Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior	Week 6 (post-test)
Secondary	Child prosocial behavior	Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior	Week 10 (follow-up)
Secondary	Child peer relationships problems	Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems	Week 6 (post-test)
Secondary	Child peer relationships problems	Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems	Week 10 (follow-up)