High Food ReinforcementNCT04280198
The Play With Me Study
A study testing Triple P Parenting Videos and Activity Boxes in people with High Food Reinforcement and Overeating, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- High Food Reinforcement, Overeating, Obesity, Childhood
- What is being tested?
- Triple P Parenting Videos and Activity Boxes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14214
About this study
Official title: Using Positive Parent-child Interactions as an Alternative Reinforcer to Promote Healthier Eating Among Young Children
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.
Read the 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
- Being tested
- Triple P Parenting Videos, Activity Boxes
- Keywords
- relative reinforcing value of food, food reinforcement, positive parenting, parenting intervention
- Medical subject headings
- Hyperphagia, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P Parenting VideosBehavioural
Four video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices.
Activity BoxesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Triple P Parenting Videos; Behavioral: Activity Boxes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 2 (baseline), Week 6 (post-test)
Secondary outcomes (17)
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
Measured: Week 6 (post-test)
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
Measured: Week 6 (post-test)
Parent-reported nurturance in parenting
Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance
Measured: Week 6 (post-test)
Parent-reported structure in parenting
Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure
Measured: Week 6 (post-test)
Parent-reported nurturance in parenting
Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more nurturance
Measured: Week 10 (follow-up)
Parent-reported structure in parenting
Comprehensive General Parenting Questionnaire. Range: 1-5, 5=more structure
Measured: Week 10 (follow-up)
Parent-reported parenting efficacy
Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy
Measured: Week 6 (post-test)
Parent-reported parenting efficacy
Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more efficacy
Measured: Week 10 (follow-up)
Parent-reported parenting satisfaction
Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction
Measured: Week 6 (post-test)
Parent-reported parenting satisfaction
Parenting Sense of Competence Questionnaire. Range: 1-6, 6=more satisfaction
Measured: Week 10 (follow-up)
Child self-regulation
Head Toes Knees Shoulders Task
Measured: Week 6 (post-test)
Child total behavioral difficulties
Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties
Measured: Week 6 (post-test)
Child overall behavioral difficulties
Strengths and difficulties questionnaire. Range=0-40, 40=more difficulties
Measured: Week 10 (follow-up)
Child prosocial behavior
Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior
Measured: Week 6 (post-test)
Child prosocial behavior
Strengths and difficulties questionnaire. Range=0-10, 10=more prosocial behavior
Measured: Week 10 (follow-up)
Child peer relationships problems
Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems
Measured: Week 6 (post-test)
Child peer relationships problems
Strengths and difficulties questionnaire. Range=0-10, 10=more peer problems
Measured: Week 10 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start26 Feb 2020
- Primary completion18 May 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Food ReinforcementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Anzman-Frasca, State University of New York at Buffalo
- Investigators
- Stephanie Anzman-Frasca, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280198
- Sponsor's protocol ID
- STUDY00004200
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Positive Parent-child Interactions as an Alternative Reinforcer to Promote Healthier Eating Among Young Children
- ClinicalTrials.gov ID
- NCT04280198
- Acronym / sponsor ID
- STUDY00004200
- Conditions
- High Food Reinforcement, Overeating, Obesity, Childhood
- Keywords
- relative reinforcing value of food, food reinforcement, positive parenting, parenting intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Triple P Parenting Videos, Behavioral: Activity BoxesParticipants 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. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple P Parenting VideosFour video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices. | Behavioural | Experimental: Group 2 - Intervention |
| Activity BoxesThere 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. | Behavioural | Experimental: Group 2 - Intervention |
Primary outcome
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
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
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
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
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
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
17 secondary outcomes
Observations of warm and sensitive parenting
Time frame: Week 6 (post-test)
Observations of child prosocial behavior
Time frame: Week 6 (post-test)
Parent-reported nurturance in parenting
Time frame: Week 6 (post-test)
Parent-reported structure in parenting
Time frame: Week 6 (post-test)
Parent-reported nurturance in parenting
Time frame: Week 10 (follow-up)
Parent-reported structure in parenting
Time frame: Week 10 (follow-up)
Parent-reported parenting efficacy
Time frame: Week 6 (post-test)
Parent-reported parenting efficacy
Time frame: Week 10 (follow-up)
Parent-reported parenting satisfaction
Time frame: Week 6 (post-test)
Parent-reported parenting satisfaction
Time frame: Week 10 (follow-up)
Child self-regulation
Time frame: Week 6 (post-test)
Child total behavioral difficulties
Time frame: Week 6 (post-test)
Child overall behavioral difficulties
Time frame: Week 10 (follow-up)
Child prosocial behavior
Time frame: Week 6 (post-test)
Child prosocial behavior
Time frame: Week 10 (follow-up)
Child peer relationships problems
Time frame: Week 6 (post-test)
Child peer relationships problems
Time frame: Week 10 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Anzman-Frasca, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple P Parenting Videos and Activity Boxes in people with High Food Reinforcement and Overeating, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's relative reinforcing value of food versus parent-child interaction (time frame: Week 6 (post-test)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.