Clinical trial NCT03982511: Improving Parent-Child Interactions to Enhance Child Health
Official title: Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Lead sponsor: Central Michigan University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Michigan
First posted: 2019-06-11
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control.
Primary purpose: PREVENTION

Brief summary: Childhood obesity is a formidable public health issue in the United States, disproportionately affecting children from lower socioeconomic status households. Onset of obesity predicts cardiometabolic risks and other health problems in adolescence and into adulthood; thus, effective and early prevention is critical. Healthy parenting may play a pivotal role in preventing early childhood obesity. Warm, responsive, and consistent parenting is associated with the development of child self-regulation as well as healthy eating and physical activity practices, and thus may be protective against obesity risk. Targeting the parent-child relationship may be especially important when facilitating behavior change in parents who have ongoing stressors (e.g., low-income families). The proposed study aims to test an adaptation of Parent-Child Interaction Therapy (PCIT), an innovative parent management program that improves the parent-child relationship and enhances general parenting skills through the use of therapeutic in vivo coaching. Our adapted version, PCIT-Health, is a selective-prevention intervention that includes content specific to improving parent-child interactions and parenting in obesity-salient contexts, such as mealtime and child screen time. This project will elucidate novel approaches to, and novel targets of, early childhood obesity prevention and will provide data critical to test PCIT-Health in a large-scale randomized controlled trial. Parent-child dyads will be randomly assigned to PCIT-Health or a waitlist control in order to accomplish the following aims: AIM 1: To assess the acceptability and feasibility of the PCIT-Health delivery and assessment methods in low-income parents of overweight young children ages 3 to 6 years. AIM 2: To test the preliminary efficacy and estimate the effect size of PCIT-Health on changes in child BMI z-score (primary outcome) from baseline to (1) intervention completion and (2) 6-month post-intervention. AIM 3: To explore the effect of PCIT-Health on the following secondary outcomes: (1) parent-child relationship quality, (2) parent behavior management skills, (3) child self-regulation, (4) child eating behaviors, (5) child physical activity, and (6) child screen media use.


Eligibility criteria: Inclusion Criteria:

* child BMI \> 5th percentile
* child born at 37+ weeks gestation, with no significant neo- or perinatal complications.

Exclusion Criteria:

* Child is experiencing clinical levels of behavior problems
* History of food allergies or medical problems or medications affecting appetite or weight
* Non-fluency in English
* Significant child or parent developmental delay
* Child currently in State custody
* Family currently involved with Child Protective Services
* Caregiver is receiving or has plans to receive other behavioral parenting interventions

Primary outcomes:
measure: Change in Child Body Mass Index (BMI) Percentile
timeFrame: Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)
measure: Change in Child Body Mass Index (BMI) Z-score
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Secondary outcomes:
measure: Child Self-regulation (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Screen Time
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Physical Activity
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Sleep (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Sleep (Via Actigraphy)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Problematic Media Use
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Parent-child Relationship Quality (Observed)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Parent-child Relationship Quality (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Pressure to Eat (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Restriction (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Emotional Feeding (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Instrumental Feeding (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Active Mediation of Television (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Restrictive Mediation of Television (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Social Coviewing of Television (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Location/Quantity of Screen Media in the Home (Parent-report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Media Parenting Practices (Observed)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Parent Feeding Practices (Observed)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Other outcomes:
measure: Child Disruptive Behaviors (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Psychological Functioning (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
measure: Child Psychosocial Strengths (Parent Report)
timeFrame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Locations:
city: Mount Pleasant
country: United States
facility: Center for Children, Families, and Communities
state: Michigan
Study officials:
affiliation: Central Michigan University
name: Sarah Domoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: