ABC Brain Games Self-Regulation Intervention

NCT ID: NCT03060863

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2018-01-31

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).

Conditions

Obesity; Self-Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1. Comparison

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

2. Executive functioning

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).

Group Type: EXPERIMENTAL

2. Executive Functioning

Intervention Type: BEHAVIORAL

Interventions will occur in 3 biweekly visits plus technology-based practice. The investigators will use computer-based working memory training to improve Executive Functioning (EF) and will use a working memory training game that has been used with children this age (N-back task).

3. Food Bias

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.

Group Type: EXPERIMENTAL

3. Food Bias

Intervention Type: BEHAVIORAL

The investigators will use attention-bias retraining techniques that have been tested in adults that have children practice approach and avoidance attentional strategies using a joystick and food images (healthy and unhealthy foods). Interventions will occur in 3 biweekly visits. 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.

4. Emotion Regulation

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

Group Type: EXPERIMENTAL

4. Emotion Regulation

Intervention Type: BEHAVIORAL

Interventions will occur in 3 biweekly visits plus home practice. The investigators will use assisted relaxation training where children are trained to monitor and control their heart rate and skin conductance using biofeedback in a computer-game context (Journey to Wild Divine).

5. Future orientation

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

Group Type: EXPERIMENTAL

5. Future orientation

Intervention Type: BEHAVIORAL

Interventions will occur in 3 biweekly visits. Children will participate in an interview protocol designed to enhance their capacity to visualize upcoming future events and describe them in detail, with the goal to make the "future" become "present".

Interventions

2. Executive Functioning

Interventions will occur in 3 biweekly visits plus technology-based practice. The investigators will use computer-based working memory training to improve Executive Functioning (EF) and will use a working memory training game that has been used with children this age (N-back task).

Intervention Type: BEHAVIORAL

3. Food Bias

The investigators will use attention-bias retraining techniques that have been tested in adults that have children practice approach and avoidance attentional strategies using a joystick and food images (healthy and unhealthy foods). Interventions will occur in 3 biweekly visits. 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.

Intervention Type: BEHAVIORAL

4. Emotion Regulation

Interventions will occur in 3 biweekly visits plus home practice. The investigators will use assisted relaxation training where children are trained to monitor and control their heart rate and skin conductance using biofeedback in a computer-game context (Journey to Wild Divine).

Intervention Type: BEHAVIORAL

5. Future orientation

Interventions will occur in 3 biweekly visits. Children will participate in an interview protocol designed to enhance their capacity to visualize upcoming future events and describe them in detail, with the goal to make the "future" become "present".

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Alison Miller

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33910138 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29050636 (View on PubMed)

Other Identifiers

HUM00104622

Identifier Type: -

Identifier Source: org_study_id