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Completed

NCT Number: NCT04280198

The Play With Me Study

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.

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Key information

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State University of New York at Buffalo

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple P Parenting Videos

Behavioral

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

Activity Boxes

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.

Primary outcomes

  1. Child's relative reinforcing value of food versus parent-child interaction

    Time frame: Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

  2. Change in child's relative reinforcing value of food versus parent-child interaction

    Time frame: Week 2 (baseline), Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

  3. Child's maximum schedule reached for food (food reinforcement)

    Time frame: Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

  4. Change in child's maximum schedule reached for food (food reinforcement)

    Time frame: Week 2 (baseline), Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

  5. Child's maximum schedule reached for parent-child interaction

    Time frame: Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

  6. Change in child's maximum schedule reached for parent-child interaction

    Time frame: Week 2 (baseline), Week 6 (post-test)

    Computer-based RRV task where child can earn portions of snacks and/or time doing an activity of choice with parent

Secondary outcomes

  1. Observations of warm and sensitive parenting

    Time frame: Week 6 (post-test)

    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

  2. Observations of child prosocial behavior

    Time frame: Week 6 (post-test)

    Coded from parent-child interaction using Iowa Family Interaction Rating Scales. Scale: child prosocial behavior. Range: 1-9, 9=more prosocial behavior

  3. Parent-reported nurturance in parenting

    Time frame: Week 6 (post-test)

    Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance

  4. Parent-reported structure in parenting

    Time frame: Week 6 (post-test)

    Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure

  5. Parent-reported nurturance in parenting

    Time frame: Week 10 (follow-up)

    Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance

  6. Parent-reported structure in parenting

    Time frame: Week 10 (follow-up)

    Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure

  7. Parent-reported parenting efficacy

    Time frame: Week 6 (post-test)

    Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy

  8. Parent-reported parenting efficacy

    Time frame: Week 10 (follow-up)

    Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy

  9. Parent-reported parenting satisfaction

    Time frame: Week 6 (post-test)

    Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction

  10. Parent-reported parenting satisfaction

    Time frame: Week 10 (follow-up)

    Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction

  11. Child self-regulation

    Time frame: Week 6 (post-test)

    Head Toes Knees Shoulders Task

  12. Child total behavioral difficulties

    Time frame: Week 6 (post-test)

    Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties

  13. Child overall behavioral difficulties

    Time frame: Week 10 (follow-up)

    Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties

  14. Child prosocial behavior

    Time frame: Week 6 (post-test)

    Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior

  15. Child prosocial behavior

    Time frame: Week 10 (follow-up)

    Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior

  16. Child peer relationships problems

    Time frame: Week 6 (post-test)

    Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems

  17. Child peer relationships problems

    Time frame: Week 10 (follow-up)

    Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems

Other outcomes

  1. Intervention compliance

    Time frame: Week 2-5

    Daily text messages (intervention group only)

  2. Intervention acceptability

    Time frame: Week 2-5

    Daily text messages (intervention group only)

  3. Intervention acceptability

    Time frame: Week 6 (post-test)

    Exit interview (intervention group only)

  4. Intervention use and acceptability

    Time frame: Week 10 (follow-up)

    Parent questionnaire

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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