Clinical trial NCT03060863: ABC Brain Games Self-Regulation Intervention
Official title: Targeting Self-Regulation to Promote Adherence and Health Behaviors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Self-Regulation
Keywords: children
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-02-23
Enrollment: 246
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to measure childhood self-regulation targets known to be associated with obesity risk and poor adherence to medical regimens and to assess whether intervening on these mechanisms can improve self-regulation. The investigators will do so in a pre-existing cohort of low-income school-age children.

Detailed description: Poor self-regulation (i.e., inability to harness cognitive, emotional or motivational resources to achieve goals) contributes to a number of unhealthy behaviors across the life course, including overeating, a lack of physical activity, smoking, alcoholism and substance abuse that are linked to poor long-term health. The self-regulation processes that generate the desire for such substances or that make it difficult to engage in healthy habits are theorized to begin very early in the lifespan. Targeting early self-regulation profiles that signal risk for engaging in unhealthy behaviors would allow more effective intervention. The investigators will assess self-regulation during pre-adolescence, a critical transition when children gain responsibility for managing their health choices and self-regulation becomes increasingly associated with health outcomes. Obesity is a complex health issue with early-emerging biological and behavioral precursors that are related to self-regulation; as such it is a good model for understanding a broad range of health conditions that require active self-management. Childhood obesity is also an ongoing public health crisis, with almost 25% of children overweight by age 4 years (35% by school-age). The goal of this study is to measure childhood self-regulation targets known to be associated with obesity risk and poor adherence to medical regimens and to assess whether intervening on these mechanisms can improve self-regulation. The investigators will do so in a cohort of children with a high rate of obesity who have been extensively phenotyped for bio-behavioral self-regulation and obesity risk factors from early childhood.

The aim is to, in low-income school-age children from extant cohorts, develop and field-test interventions designed to address self-regulation targets using a Multiphase Optimization Strategy (MOST) design to detect intervention effectiveness and child or family factors (e.g., maternal education, family stress, early childhood eating or stress regulation pattern) that may moderate intervention effects. The investigators hypothesize that our interventions will cause change in the self-regulation targets most closely related to the intervention components (e.g., EF-focused intervention will change EF targets).

Eligibility criteria: Inclusion Criteria:

* Participant in the ABC (Appetite, Behavior, and Cortisol) cohort being followed longitudinally since recruitment in 2009-2013
* Primary caregiver (mostly mother) has \< 4-year college degree at time of initial enrollment (first study wave; child age \~4 years)
* Child born at 36+ weeks gestation
* Child had no significant perinatal complications.

Exclusion Criteria:

* History of food allergies or medical problems affecting growth
* Non-fluency in English
* Foster child
* Medications affecting cortisol
* Significant developmental delay.

Primary outcomes:
measure: Change in Working Memory
timeFrame: 6 weeks
measure: Change in Inhibitory Control
timeFrame: 6 weeks
measure: Change in Behavior Rating Inventory of Executive Functioning (BRIEF)
timeFrame: 6 weeks
measure: Change in emotional and behavioral displays indicating frustration
timeFrame: 6 weeks
measure: Change in SIDES Affect dysregulation scale
timeFrame: 6 weeks
measure: Change in Children's Emotion Management Scales
timeFrame: 6 weeks
measure: Change in NIH Toolbox scale
timeFrame: 6 weeks
measure: Change in Positive and Negative Affect Schedule for children
timeFrame: 6 weeks
measure: Change in episodic future thinking
timeFrame: 6 weeks
measure: Change in NIH Self-Efficacy
timeFrame: 6 weeks
measure: Change in Future Time Perspective subscale from the Zimbardo Time Perspective Questionnaire
timeFrame: 6 weeks
measure: Change in Ratio Reinforcing Computer Task
timeFrame: 6 weeks
measure: Change in implicit food bias
timeFrame: 6 weeks
measure: Change in Power of Food Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alison Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo SL, Gearhardt AN, Fredericks EM, Katz B, Sturza J, Kaciroti N, Gonzalez R, Hunter CM, Sonneville K, Chaudhry K, Lumeng JC, Miller AL. Targeted self-regulation interventions in low-income children: Clinical trial results and implications for health behavior change. J Exp Child Psychol. 2021 Aug;208:105157. doi: 10.1016/j.jecp.2021.105157. Epub 2021 Apr 25.
citation: Miller AL, Gearhardt AN, Fredericks EM, Katz B, Shapiro LF, Holden K, Kaciroti N, Gonzalez R, Hunter C, Lumeng JC. Targeting self-regulation to promote health behaviors in children. Behav Res Ther. 2018 Feb;101:71-81. doi: 10.1016/j.brat.2017.09.008. Epub 2017 Sep 28.