ObesityNCT03060863
ABC Brain Games Self-Regulation Intervention
A study testing 2. Executive Functioning, 3. Food Bias and 4. Emotion Regulation in people with Obesity and Self-Regulation, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Obesity, Self-Regulation
- What is being tested?
- 2. Executive Functioning, 3. Food Bias and 4. Emotion Regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- History of food allergies or medical problems affecting growth
- Non-fluency in English
- Foster child
- Medications affecting cortisol
- Significant developmental delay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Self-Regulation to Promote Adherence and Health Behaviors in Children
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.
Read the 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
- Being tested
- 2. Executive Functioning, 3. Food Bias, 4. Emotion Regulation, 5. Future orientation
- Keywords
- children
- Medical subject headings
- Obesity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2. Executive FunctioningBehavioural
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 BiasBehavioural
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 RegulationBehavioural
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 orientationBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| 1. Comparison | No intervention | Families in this group will not receive any of the interventions. |
| 2. Executive functioning | Experimental | 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). Receives: Behavioral: 2. Executive Functioning |
| 3. Food Bias | Experimental | 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. Receives: Behavioral: 3. Food Bias |
| 4. Emotion Regulation | Experimental | Children in this arm will use a computer-based, game-like relaxation training to teach emotion regulation and coping strategies. Receives: Behavioral: 4. Emotion Regulation |
| 5. Future orientation | Experimental | Children in this arm will participate in an interview training protocol to promote their capacity to utilize and articulate a future oriented perspective. Receives: Behavioral: 5. Future orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Working Memory
Working memory is assessed using a standardized digit span task from the Wechsler Intelligence Scale for Children-WISC-IV, which requires participants to recite digits they have just heard in progressively longer sequences. The longest correct span of digits the participants repeats is the index of working memory.
Measured: 6 weeks
Change in Inhibitory Control
Inhibitory control is measured using a go/no-go task. In this task, children are taught to play a computer-based "Zoo" game wherein their goal is to help the zookeeper find animals that have escaped and are loose in the zoo. Children are instructed to press a key to respond as fast as possible when they see the "go" stimulus (i.e., an orangutan who is "helping" the zookeeper retrieve the escaped animals, presented for 300 ms) but not when they see the no-go stimulus (i.e., any other animal that has "escaped"). The task thus requires children to demonstrate the capacity to inhibit the response to "go" when they see the "helper" animal, and indexes inhibitory control. Scores on this task are scored based on accuracy and reaction time.
Measured: 6 weeks
Change in Behavior Rating Inventory of Executive Functioning (BRIEF)
Parents complete the 86-item Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF yields two broad subscales of Behavioral Regulation and Metacognition that reflect the child's planning and organizing capabilities, attention shifting, working memory, and emotional control.
Measured: 6 weeks
Change in emotional and behavioral displays indicating frustration
Child emotional and behavioral displays indicating frustration in response to a task designed to be frustrating (a lockbox with a wrong key) are videotaped and coded for latency to and intensity of child negative affect (e.g., frown, cry) or behavioral indicators of frustration (e.g., loud sigh, set keys down roughly).
Measured: 6 weeks
Change in SIDES Affect dysregulation scale
Individual interview using SIDES Affect dysregulation scale to assess the child's ability to control feelings and how much strong feelings get in the way of doing things (e.g., "small problems got me very upset").
Measured: 6 weeks
Change in Children's Emotion Management Scales
Children report on their tendency to engage in reappraisal and suppression emotion regulation strategies using the Children's Emotion Management Scales (e.g., "when I am feeling mad, I can stop myself from losing my temper"). Children report on the use of such strategies for feelings of anger, sadness, and worry and subscales are created to generate effective emotion management strategy scores for each emotion, and overall.
Measured: 6 weeks
Change in NIH Toolbox scale
Parents report on child perceived stress responses, or how well the parent views the child's capacity to cope with stress, using the parent-report NIH Toolbox scale to assess perceived stress.
Measured: 6 weeks
Change in Positive and Negative Affect Schedule for children
Parents report on child positive and negative mood using the Positive and Negative Affect Schedule for children, which presents parents with different positively- and negatively-valenced words and asks them to indicate which words best describe the way they perceive the child to feel, in general (e.g., upset, scared vs. interested, excited). Responses are summed to generate positive and negative affect scores.
Measured: 6 weeks
Change in episodic future thinking
The interviewer asks children to think of three different upcoming future events that could happen over the next few days, next week, and the next few months, and to describe each event. The interview is audiotaped and later coded using an adaptation of prior coding systems.Indicators of episodic future thinking include use of rich, descriptive detail, vivid imagery, future-oriented language (e.g., "we will…"), and coherent narratives. Coding of the interviews is thus based on the level of detailed description of specific events; child use of future-oriented language; mental state language; and narrative coherence, and scores for richness of episodic future thinking language are generated.
Measured: 6 weeks
Change in NIH Self-Efficacy
The NIH Self-Efficacy questionnaire assesses a participant's belief in his/her capacity to manage and have control over meaningful events (e.g., "I can manage to solve difficult problems if I try hard enough").
Measured: 6 weeks
Change in Future Time Perspective subscale from the Zimbardo Time Perspective Questionnaire
Children indicate how much different items reflect their views ("I can manage to solve difficult problems if I try hard enough"; "I finish projects on time by working on them a little bit every day") and scores are generated to reflect the level of future-oriented time perspective .
Measured: 6 weeks
Change in Ratio Reinforcing Computer Task
Relative reinforcing value (RRV) for food is determined by measuring child responses on a Ratio Reinforcing Computer Task to obtain palatable food. The child is shown how to play the game on a computer and told to play the game to win candy prizes (chocolate, gummy candy, etc.). Each computer screen displays three boxes containing different shapes, and each time a key is pressed the shapes rotate and change. When all shapes match, the child receives a point and for every five points, is given a ticket to use to redeem for candy at the end of the visit. The schedule of reinforcement begins at 10 presses to earn one point and doubles each time a ticket is earned (Progressive Ratio (PR) 20, PR 40, PR 80, PR 160, PR 320, PR 640, PR 1280, PR 2560, PR 5120, PR 10240). Food reinforcement is identified by the highest reinforcement schedule completed by the child to earn candy, with higher values indicating greater motivation to work for food, indexing food reward.
Measured: 6 weeks
Change in implicit food bias
This task assesses implicit associations between images of chocolate and "stopping" versus "going". Children are first shown how to press buttons based on whether they see a "stop" (e.g., hand signaling stop) or a "go" signal (e.g., walk sign; 16 trials). In block 2 (48 trials) children sort the "stop" or "go" signals by pressing one of the buttons when one of the signals is paired with an image of chocolate (e.g., "go+chocolate") and the other button for the other (unpaired) signal ("stop"). In block 3 (48 trials), the pattern is reversed and children sort the "stop" or "go" signals based on the alternate signal-chocolate pairing (e.g., "stop+chocolate" vs. "go"). Scores are calculated using the D600 scoring protocol such that higher values on the task indicate a stronger implicit association between chocolate and "go" compared to chocolate and "stop" signals, suggesting an implicit bias toward chocolate.
Measured: 6 weeks
Change in Power of Food Scale
Children complete this 15-item scale that assesses individual differences in sensitivity to food cues in the environment (e.g.. "I think about food even when I'm not truly hungry ") and the ability of these cues to increase desire for food (e.g., "If I see or smell a food I like, I get a powerful urge to have some ").
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Sep 2015
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Alison Miller, University of Michigan
- Investigators
- Alison Miller, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060863
- Sponsor's protocol ID
- HUM00104622
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33910138Miller 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.
PubMed 29050636
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Self-Regulation to Promote Adherence and Health Behaviors in Children
- ClinicalTrials.gov ID
- NCT03060863
- Acronym / sponsor ID
- HUM00104622
- Conditions
- Obesity, Self-Regulation
- Keywords
- children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. Comparison | No intervention | –Families in this group will not receive any of the interventions. |
| 2. Executive functioning | Experimental | Behavioral: 2. Executive FunctioningChildren 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). |
| 3. Food Bias | Experimental | Behavioral: 3. Food BiasChildren 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 | Experimental | Behavioral: 4. Emotion RegulationChildren in this arm will use a computer-based, game-like relaxation training to teach emotion regulation and coping strategies. |
| 5. Future orientation | Experimental | Behavioral: 5. Future orientationChildren in this arm will participate in an interview training protocol to promote their capacity to utilize and articulate a future oriented perspective. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- History of food allergies or medical problems affecting growth
- Non-fluency in English
- Foster child
- Medications affecting cortisol
- Significant developmental delay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2. Executive FunctioningInterventions 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). | Behavioural | 2. Executive functioning |
| 3. Food BiasThe 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. | Behavioural | 3. Food Bias |
| 4. Emotion RegulationInterventions 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). | Behavioural | 4. Emotion Regulation |
| 5. Future orientationInterventions 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". | Behavioural | 5. Future orientation |
Primary outcome
Change in Working Memory
Time frame: 6 weeks
Working memory is assessed using a standardized digit span task from the Wechsler Intelligence Scale for Children-WISC-IV, which requires participants to recite digits they have just heard in progressively longer sequences. The longest correct span of digits the participants repeats is the index of working memory.
Change in Inhibitory Control
Time frame: 6 weeks
Inhibitory control is measured using a go/no-go task. In this task, children are taught to play a computer-based "Zoo" game wherein their goal is to help the zookeeper find animals that have escaped and are loose in the zoo. Children are instructed to press a key to respond as fast as possible when they see the "go" stimulus (i.e., an orangutan who is "helping" the zookeeper retrieve the escaped animals, presented for 300 ms) but not when they see the no-go stimulus (i.e., any other animal that has "escaped"). The task thus requires children to demonstrate the capacity to inhibit the response to "go" when they see the "helper" animal, and indexes inhibitory control. Scores on this task are scored based on accuracy and reaction time.
Change in Behavior Rating Inventory of Executive Functioning (BRIEF)
Time frame: 6 weeks
Parents complete the 86-item Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF yields two broad subscales of Behavioral Regulation and Metacognition that reflect the child's planning and organizing capabilities, attention shifting, working memory, and emotional control.
Change in emotional and behavioral displays indicating frustration
Time frame: 6 weeks
Child emotional and behavioral displays indicating frustration in response to a task designed to be frustrating (a lockbox with a wrong key) are videotaped and coded for latency to and intensity of child negative affect (e.g., frown, cry) or behavioral indicators of frustration (e.g., loud sigh, set keys down roughly).
Change in SIDES Affect dysregulation scale
Time frame: 6 weeks
Individual interview using SIDES Affect dysregulation scale to assess the child's ability to control feelings and how much strong feelings get in the way of doing things (e.g., "small problems got me very upset").
Change in Children's Emotion Management Scales
Time frame: 6 weeks
Children report on their tendency to engage in reappraisal and suppression emotion regulation strategies using the Children's Emotion Management Scales (e.g., "when I am feeling mad, I can stop myself from losing my temper"). Children report on the use of such strategies for feelings of anger, sadness, and worry and subscales are created to generate effective emotion management strategy scores for each emotion, and overall.
Change in NIH Toolbox scale
Time frame: 6 weeks
Parents report on child perceived stress responses, or how well the parent views the child's capacity to cope with stress, using the parent-report NIH Toolbox scale to assess perceived stress.
Change in Positive and Negative Affect Schedule for children
Time frame: 6 weeks
Parents report on child positive and negative mood using the Positive and Negative Affect Schedule for children, which presents parents with different positively- and negatively-valenced words and asks them to indicate which words best describe the way they perceive the child to feel, in general (e.g., upset, scared vs. interested, excited). Responses are summed to generate positive and negative affect scores.
Change in episodic future thinking
Time frame: 6 weeks
The interviewer asks children to think of three different upcoming future events that could happen over the next few days, next week, and the next few months, and to describe each event. The interview is audiotaped and later coded using an adaptation of prior coding systems.Indicators of episodic future thinking include use of rich, descriptive detail, vivid imagery, future-oriented language (e.g., "we will…"), and coherent narratives. Coding of the interviews is thus based on the level of detailed description of specific events; child use of future-oriented language; mental state language; and narrative coherence, and scores for richness of episodic future thinking language are generated.
Change in NIH Self-Efficacy
Time frame: 6 weeks
The NIH Self-Efficacy questionnaire assesses a participant's belief in his/her capacity to manage and have control over meaningful events (e.g., "I can manage to solve difficult problems if I try hard enough").
Change in Future Time Perspective subscale from the Zimbardo Time Perspective Questionnaire
Time frame: 6 weeks
Children indicate how much different items reflect their views ("I can manage to solve difficult problems if I try hard enough"; "I finish projects on time by working on them a little bit every day") and scores are generated to reflect the level of future-oriented time perspective .
Change in Ratio Reinforcing Computer Task
Time frame: 6 weeks
Relative reinforcing value (RRV) for food is determined by measuring child responses on a Ratio Reinforcing Computer Task to obtain palatable food. The child is shown how to play the game on a computer and told to play the game to win candy prizes (chocolate, gummy candy, etc.). Each computer screen displays three boxes containing different shapes, and each time a key is pressed the shapes rotate and change. When all shapes match, the child receives a point and for every five points, is given a ticket to use to redeem for candy at the end of the visit. The schedule of reinforcement begins at 10 presses to earn one point and doubles each time a ticket is earned (Progressive Ratio (PR) 20, PR 40, PR 80, PR 160, PR 320, PR 640, PR 1280, PR 2560, PR 5120, PR 10240). Food reinforcement is identified by the highest reinforcement schedule completed by the child to earn candy, with higher values indicating greater motivation to work for food, indexing food reward.
Change in implicit food bias
Time frame: 6 weeks
This task assesses implicit associations between images of chocolate and "stopping" versus "going". Children are first shown how to press buttons based on whether they see a "stop" (e.g., hand signaling stop) or a "go" signal (e.g., walk sign; 16 trials). In block 2 (48 trials) children sort the "stop" or "go" signals by pressing one of the buttons when one of the signals is paired with an image of chocolate (e.g., "go+chocolate") and the other button for the other (unpaired) signal ("stop"). In block 3 (48 trials), the pattern is reversed and children sort the "stop" or "go" signals based on the alternate signal-chocolate pairing (e.g., "stop+chocolate" vs. "go"). Scores are calculated using the D600 scoring protocol such that higher values on the task indicate a stronger implicit association between chocolate and "go" compared to chocolate and "stop" signals, suggesting an implicit bias toward chocolate.
Change in Power of Food Scale
Time frame: 6 weeks
Children complete this 15-item scale that assesses individual differences in sensitivity to food cues in the environment (e.g.. "I think about food even when I'm not truly hungry ") and the ability of these cues to increase desire for food (e.g., "If I see or smell a food I like, I get a powerful urge to have some ").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Derived from this study: PubMed 33910138Lo 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.
- Derived from this study: PubMed 29050636Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Miller, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2. Executive Functioning, 3. Food Bias and 4. Emotion Regulation in people with Obesity and Self-Regulation, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Working Memory (time frame: 6 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.