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N/A N=59 Randomized Single-blind Prevention

Improving Parent-Child Interactions to Enhance Child Health

Child Obesity

Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Change in Child Body Mass Index (BMI) Percentile — 3.66; 1.74; 1.12; 0.88 percentile — p=.73

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PCIT-Health (Behavioral)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Central Michigan University
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Child Body Mass Index (BMI) Percentile
3.66; 1.74; 1.12; 0.88 .73
PRIMARY
Change in Child Body Mass Index (BMI) Z-score
0.11; 0.06; 0.01; 0.02 .73
SECONDARY
Child Self-regulation (Parent Report)
0.23; 0.03; 0.26; 0.26 0.12
SECONDARY
Child Screen Time
-5.72; 0.36; -2.92; -8.75 0.28
SECONDARY
Child Physical Activity
38.26; 2.94; 32.55; 16.46; -59.17; 5.23 0.16
SECONDARY
Child Sleep (Parent Report)
-1.0; -0.36; -1.05; -2.44 0.41
SECONDARY
Child Sleep (Via Actigraphy)
-10.15; 2.47; -29.54; 9.29 0.42
SECONDARY
Child Problematic Media Use
-0.30; -0.38; -0.36; -0.15 0.77
SECONDARY
Parent-child Relationship Quality (Observed)
7.65; 0.00; 6.35; -0.11 0.005 sig
SECONDARY
Parent-child Relationship Quality (Parent Report)
-9.59; 7.64; -13.21; 6.22 0.02 sig
SECONDARY
Pressure to Eat (Parent-report)
-0.84; -0.59; -0.59; -0.58 0.50
SECONDARY
Restriction (Parent-report)
-0.71; -0.25; -0.88; -0.53 0.17
SECONDARY
Emotional Feeding (Parent-report)
-0.19; -0.16; -0.37; -0.20 0.91
SECONDARY
Instrumental Feeding (Parent-report)
-0.74; -0.27; -0.91; -0.36 0.03 sig
SECONDARY
Active Mediation of Television (Parent-report)
2.86; 0.64; 2.95; 0.44 0.05
SECONDARY
Restrictive Mediation of Television (Parent-report)
2.36; -1.27; 1.53; 0.22 0.002 sig
SECONDARY
Social Coviewing of Television (Parent-report)
1.14; 0.45; 1.11; 0.78 0.53
SECONDARY
Location/Quantity of Screen Media in the Home (Parent-report)
0.32; 0.18; 0.49; -0.39; -0.21; 0.19 0.91
SECONDARY
Media Parenting Practices (Observed)
-0.39; 0.11; -0.33; 0.00; -0.09; 0.11 0.03 sig
SECONDARY
Parent Feeding Practices (Observed)
0.09; -0.33; 0.11; 0.14; 0.13; -0.11 0.009 sig

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03982511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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