Center for Children, Families, and Communities
Mount Pleasant, Michigan, 48858, United States
NCT Number: NCT03982511
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.
Looking for future studies?
Notify Me30 month–84 month
All sexes
Interventional
Not applicable
Mount Pleasant, Michigan, 48858, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time).
Other names: PATCH Program
Time frame: Pre-intervention (T1), post-intervention (T2;4 months after pre-intervention), and six-month follow-up (T3;10 months after pre-intervention)
Change in child BMI percentile will be calculated using standardized anthropometric measurement (height and weight) procedure
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Change in child BMI z-score will be calculated using standardized anthropometric measurement (height and weight) procedure. The z-score is a standard deviation away from the mean, based on the CDC growth charts. Higher z-scores indicate greater weight status. A Z-score of 0 equals the population mean, based on age and sex.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Emotion Regulation (ER) Checklist, higher scores = greater regulation (better outcome). Mean calculation for total score, with Min=1 to Max=4
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Parent report of weekly amount of time child spends viewing/using screen media. Scores range from 0-168, with total scores reflecting sum of daily screen time across multiple types of screen media. Higher scores = more screen time.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Measured by Actigraph accelerometer to assess sedentary, moderate, moderate-to-vigorous, and vigorous physical activity (MVPA)
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Measured by parent report of bedtime, wake time, and naps.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Measured by Actigraph accelerometer.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Measured by the parent-report via Problematic Media Use Measure (Domoff et al., 2019). Higher scores = greater problematic media use. Total scores = mean of items; Min = 1 to Max = 5.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Dyadic Parent-Child Interaction Coding System-IV (DPICS-IV) will be used. The DPICS provides a reliable measure of parent-child relationship quality (e.g., parents' child-centered skills, parent and child positive and negative physical and verbal interactions) and parent behavior management skills (e.g., use of contingent reinforcement, effective discipline, child compliance). This outcome reflects behavioral observation of parents' child-centered skills ("DO" skills) during child led play. This is a count variable that can range from 0 displayed skills (min) with no determined maximum. Higher numbers = more skills (better outcome).
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Parent-child Dysfunctional Interaction (PCDI) subscale of the Parenting Stress Index will be used as the parent-report of parent-child relationship quality. Values range from 12 to 60, with higher scores indicating greater dysfunction in (poorer quality of) the parent-child relationship.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Child Feeding Questionnaire (CFQ)- Pressure to Eat subscale will be calculated. This subscale score is a mean, with minimum of 1 and maximum of 5 (higher scores = more pressure to eat, a worse outcome).
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Child Feeding Questionnaire (CFQ)-Restriction subscale will be calculated. A mean is calculated for this subscale (min = 1 to max = 5). Higher scores = greater restriction of food (poorer outcome).
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Child Feeding Questionnaire (CFQ)- Emotional Feeding subscale will be calculated with a mean of responses to items. Min = 1 to max = 5. Higher scores reflect worse outcome.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Parental Feeding Questionnaire (PFQ)- Instrumental Feeding subscale will be calculated. Mean calculation of responses, with scores ranging from 1 (min) to 5 (max). Higher scores reflect poorer outcome.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Instructive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Restrictive Mediation subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Scores on the Social Coviewing subscale of the Parental Mediation Scale (Valkenburg et al., 1999) will be calculated via sum score of 5 items. Min = 5, max = 20, higher scores = better outcome.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Parents will report on the location/quantity of screen media in home and child's bedroom.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Family mealtime observations will be coded for presence and use of screen media (TV, mobile device present, other media present). Coding of the observed behavior is as follows: TV on = 1 if TV is on during mealtime, TV on = 0 if TV is off during mealtime, lower values = better outcomes. Mobile device present = 1 if a mobile device is present, 0 if no mobile device is present, with lower values= better outcomes. Other media present = 1 if other screens are present, 0 if no other screens are present (lower values=better outcomes).
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Family mealtime observations will be coded using a modified version of the Mealtime Interaction Coding System. Aspects of task accomplishment (TA) and behavior control BC) were coded. Scores could range from 1 (min) to 3 (max), with higher scores = better outcomes.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Eyberg Child Behavior Inventory (ECBI); intensity t-score. Higher t-scores indicate poorer outcomes (i.e., greater intensity of behavior problems). T-scores have a mean of 50 (SD = 10). T-scores of 60 or higher indicate clinical significance.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Behavior Assessment System for Children (BASC-3); internalizing symptoms t-score (lower scores better outcome) and adaptive skills t-score (higher scores better outcome). T-scores M = 50, SD = 10, with clinical cut-offs at 70 or above.
Time frame: Pre-intervention (T1), post-intervention (T2; 4 months after pre-intervention), and six-month follow-up (T3; 10 months after pre-intervention)
Psychosocial Strengths Inventory for Children and Adolescents (PSICA). Scores reflect total sum, ranging from 36 (min) to 252 (max); higher scores indicate better outcomes.
Central Michigan University
Other
Improving Parent-Child Interactions to Prevent Child Obesity in Early Childhood
Acronym: PCIT-Health
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06486922
Behavior, Behavior, Animal
New Hyde Park, New York, United States
View Trial DetailsNCT04802291
Behavior, Body Weight
New Brunswick, New Jersey, United States
View Trial DetailsNCT04754269
Body Weight, Child Development
San Francisco, California, United States
View Trial DetailsNCT07304141
Body Weight, Child Obesity
Gothenburg, Sweden
View Trial Details