TRUST Study of Adolescent Weight Self-Management



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 12
Updated:7/12/2018
Start Date:January 15, 2018
End Date:July 2019
Contact:Heather K Hardin, PhD
Email:hkh10@case.edu
Phone:216-368-5129

Use our guide to learn which trials are right for you!

Pilot Study Evaluating the Effects of a Trust-Building Intervention on Adolescent Weight Self-Management Behaviors

The purpose of this pilot study is to evaluate the effect of the Trust-building weight
Self-management Together (TRUST) intervention on weight self-management behaviors and neural
processing in overweight/obese adolescents. Study aims include comparing the effects of the
TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese
early adolescents and exploring differences in neural processing (DMT/TPN switching and
reward activation).

Background Adolescent obesity is a serious concern in the US, placing young people at risk
for multiple chronic conditions. Family-based interventions are most effective with this
challenge1, but adolescents' trust of their parents diminishes around age 14 as a result of
developmental brain changes2-4. This distrust may thwart family-based weight self-management
interventions; therefore, in this study the investigators will assess the effects of building
trust between adolescents ages 10-12 and their parents, alongside weight self-management
skills. Trust is a reciprocal quality between dyads that crosses the cognitive, affective,
and behavioral domains and consists of honesty, receptivity to disclosures, and perceived
compatibility between one's actions and words, which results in a sense of psychological
safety from criticism, embarrassment, or harm.5 Because of its central role in
adolescent-parent social interactions/relationships, trust may be a key factor in acquiring
and sustaining healthy behaviors. Despite literature supporting the importance of
interpersonal social interactions in making behavior change1,6, no studies to date have
simultaneously examined both the biological and behavioral pathways through which trust in
interpersonal interactions elicits behavior change. Thus, we employ a study design that
includes basic research on the role of trust as a putative intervention target for behavior
change in the context of an ongoing experimental clinical study testing the effects of a
family trust-building behavioral intervention designed to reduce BMI in overweight/obese
adolescents. We posit that adolescent-parent trust is a unique and potentially important
interpersonal communication putative target to engage behavior change to improve healthy
eating, physical activity, and sleep in overweight/obese adolescents, which will in turn
reduce BMI.

Research in the area of cognitive processing has identified two broad cortical neural
networks, the Task Positive Network (TPN), which is involved with using skills, knowledge and
self-monitoring for problem solving and goal-directed action, and the Default Mode Network
(DMN), which focuses on emotion-management, self-awareness and relationships. Neural network
activity is consistently observable on fMRI. These broad networks tend to be antagonistic,
such that when one network is activated, the other is inhibited; this inhibition/activation
of the two modes may have important implications for self-management efforts, since an
individual can only efficiently adopt one mode—processing either tasks or emotions--at a
given time.7,8 The Analytic v. Emotional network theory suggests that flexible and balanced
activity between modes is optimal9-11 and may be modified by learning/training, including
practices such as meditation.12

In the work of one of the SMART Center Core leaders 7,13, Dr. Anthony Jack, fMRI revealed
that individuals, when presented with an analytical (mechanical) problem, tended to activate
analytic processing while deactivating empathic (emotional) processing. Conversely, when
presented with a social problem, individuals tended to deactivate the analytic processing
pathways in favor of increased emotional processing. These compelling findings provide an
intriguing new way to examine an individual's approach to health behaviors and provide a new
view into the brain-behavior connection. Jack's work 14,15 has shown that "coaching" exerts a
dose-dependent effect on brain regions associated with motivation. In particular, focused
training increased activity in the ventral-medial prefrontal cortex (VMPFC in left side of
Figure 2) and adjacent regions of sub-genual anterior cingulate and nucleus accumbens. These
regions, which are part of the default mode network, are implicated in motivation. In
addition to identifying differences in brain function and connectivity,15 we are also
examining any structural changes in brain anatomy brought about by the interventions. These
are hypothesized to occur in the same regions as functional changes.16,17 Prior studies have
demonstrated that residual activity in the DMN, during the performance of tasks sub served by
the TPN, causes errors and lapses of attention.18,19 On the other hand, the DMN plays a key
role in social cognition and motivation, specifically the generation of affective meaning
15,20,21 or purpose in life. A key hypothesis is that effective tuning of DMN function is
essential for effective TPN function, which is required for successful self-management.
Although neural and cognitive capacities which underlie self-management behavior may be
non-specific in nature, identifying key mechanisms and signatures of effective interventions
will better inform theoretical frameworks of self-management science.

Significance Our premise is that self-management interventions that target both analytic and
emotional components of neurocognitive processing will be most effective in helping
individuals achieve self-management outcomes. We are using functional magnetic resonance
imaging (fMRI) to examine the relationship between two large-scale cortical networks, the
default mode network (DMN) and the task positive network (TPN), and their contributions to
behavior. Numerous studies have demonstrated that these networks may suppress each other, as
measured both during task performance and in the resting state, which represents a marker of
psychological health 22. The investigators interpret these findings as the ability to
flexibly move between distinct cognitive modes associated with each network 13. A key
hypothesis is that effective tuning of DMN function is essential for effective TPN function,
and in turn, optimal performance of self-management activities. We posit that the TRUST
intervention will influence the adolescent's emotional (DMT) neural processing through the
trust-building component, while the analytic (TPN) neural processing will be influenced by
the skills building component of the intervention, both of which work together to promote
healthy weight self-management behaviors 23. In addition, the investigators hypothesize that
the TRUST intervention will influence the adolescent's neurological reward activation between
social reward and palatable food reward demonstrated in the ventral striatum 24,25.

As demonstrated in our model—consistent with the P30 Center of Excellence in Self-Management
Research (SMART) framework being used for all SMART Center studies—the investigators
hypothesize that an adolescent's weight self-management behaviors are influenced by the
ability of the individual to balance DMT and TPN neural processing. the investigators posit
that a reduction of body mass index (BMI) and an improvement in quality of life (QOL) will
result from weight self-management behaviors (eating, physical activity, sleep) as mediated
by two neural processes (DMT/TPN task-switching, reward activation), adolescent trust of
parent, parent trust of adolescent, adolescent/parent relationship quality, social support,
decision-making, self-efficacy, patient activation, and self-regulation. The influence of
potential moderators (gender, binge-eating, perceived stress, depressive symptoms, executive
functioning, parenting style) will be assessed for their effect on the relationship between
the intervention and the proximal and distal outcomes. The investigators will conduct a
two-group intervention trial to describe the effects of the TRUST intervention on BMI, QOL,
and cognitive task switching between the DMT and TPN neural networks.

If the findings confirm the hypotheses, the intervention can serve as a model for improving
adolescent weight self-management behaviors. The conduct of this project will also provide
invaluable insights on the neurocognitive underpinnings of trust-building and its role as a
facilitator of adolescent weight self-management. Specifically, the knowledge gained from
this project will provide a foundational evidence on how trust-building in primary
relationships can lead to enhanced states of self-management and reward sensitivity.
Improvements in weight self-managements behaviors have shown to improve health outcomes.
Successful weight self-management behaviors are associated with increased survival and
decreased morbidity. If successful, this trust-building weight self-management will provide
an acceptable and feasible self-management intervention that allows parents and adolescents
to work together to improve the health and well-being of the family. In general, the
potential benefits of this project outweighs the potential risks, and we have an experienced
team of investigators and research staff that are prepared to address the minimal risks that
may occur.

Purpose/Aims

The purpose of this pilot study is to evaluate the effect of the Trust-building weight
Self-management Together (TRUST) intervention on weight self-management behaviors and neural
processing in overweight/obese adolescents. The aims of this two-group randomized trial are
to:

1. Compare the effects of the TRUST intervention with Enhanced Usual Care on BMI and QOL in
overweight/obese early adolescents;

2. Determine the extent to which gender, binge-eating, perceived stress, depressive
symptoms, executive functioning, and parenting style moderate the effect of TRUST on BMI
and QOL;

3. Compare the effects of the TRUST intervention with Enhanced Usual Care on weight
self-management behaviors (eating, physical activity, sleep);

4. Determine the extent to which gender, binge-eating, perceived stress, depressive
symptoms, executive functioning, and parenting style moderate the effect of TRUST on
weight self-management behaviors (eating, physical activity, sleep); and

5. Explore differences in neural processing (DMT/TPN task-switching, reward activation) in
the TRUST intervention and Enhanced Usual Care group outcomes.

Inclusion Criteria:

- 10-12 year old Cleveland Metropolitan School District student

- identified as overweight or obese (BMI >85th percentile for age/sex during school
screenings)

- able to read, speak, and understand the English language

- able to complete a self-administered questionnaire

Exclusion Criteria:

- taking medications that alter appetite or weight

- stage 2 hypertension or stage 1 hypertension with end organ damage

- severe behavioral problems that preclude group participation (as reported by
parent/guardian)

- child involvement in another weight management program

- pregnancy

- family expectation to move from the region within 1 year
We found this trial at
1
site
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Phone: 216-368-5129
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials