N/A
N=59
Improving Parent-Child Interactions to Enhance Child Health
Child Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03982511 ↗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
| Outcome | Result | p-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
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.