ABC Brain Games Self-Regulation Intervention

University of Michigan

Status: Completed

Conditions: Obesity; Self-Regulation

Treatments: Behavioral: 2. Executive Functioning; Behavioral: 3. Food Bias; Behavioral: 4. Emotion Regulation; Behavioral: 5. Future orientation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03060863

HUM00104622

Details and patient eligibility

About

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.

Full 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).

Enrollment: 246 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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246 participants in 5 patient groups

1. Comparison

No Intervention group

Description:

Families in this group will not receive any of the interventions.

2. Executive functioning

Experimental group

Description:

Children in this arm will have the opportunity to use a computer-based working memory training game to practice recalling stimuli with an increasing number of presentations prior ("n-back" task).

Treatment:

Behavioral: 2. Executive Functioning

3. Food Bias

Experimental group

Description:

Children in this arm will use a computer-based approach avoidance task to reduce attentional biases for food by using a joystick to push away images of nonhealthy foods and pull closer images of healthy foods.

Treatment:

Behavioral: 3. Food Bias

4. Emotion Regulation

Experimental group

Description:

Children in this arm will use a computer-based, game-like relaxation training to teach emotion regulation and coping strategies.

Treatment:

Behavioral: 4. Emotion Regulation

5. Future orientation

Experimental group

Description:

Children in this arm will participate in an interview training protocol to promote their capacity to utilize and articulate a future oriented perspective.

Treatment:

Behavioral: 5. Future orientation