The Play With Me Study

NCT04280198 | Completed

• 1 other identifier: STUDY00004200
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

High Food Reinforcement; Overeating; Obesity, Childhood

Keywords

relative reinforcing value of food; food reinforcement; positive parenting; parenting intervention

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (17)

• Observations of warm and sensitive parenting

  Week 6 (post-test)

• Observations of child prosocial behavior

  Week 6 (post-test)

• Parent-reported nurturance in parenting

  Week 6 (post-test)

• Parent-reported structure in parenting

  Week 6 (post-test)

• Parent-reported nurturance in parenting

  Week 10 (follow-up)

Other Outcomes (4)

• Intervention compliance

  Week 2-5

• Intervention acceptability

  Week 2-5

• Intervention acceptability

  Week 6 (post-test)

Study Arms (2)

No Intervention: Group 1 - Control

NO INTERVENTION

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.

Experimental: Group 2 - Intervention

EXPERIMENTAL

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.

Behavioral: Triple P Parenting Videos; Behavioral: Activity Boxes

Interventions

Triple P Parenting Videos BEHAVIORAL

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

Experimental: Group 2 - Intervention

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.

Experimental: Group 2 - Intervention

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Hyperphagia; Pediatric Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Stephanie Anzman-Frasca, PhD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Membership in the "intervention" vs. "control" group will not be discussed as such, but participants will know whether they receive intervention activities early (intervention group) or after the post-test assessment (control group)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: February 26, 2020
• Primary Completion: May 18, 2022
• Study Completion: June 20, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)