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Adolescent ObesityTRUSTNCT03016247

TRUST Study of Adolescent Weight Self-Management

A study testing TRUST Intervention in people with Adolescent Obesity, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Obesity
What is being tested?
TRUST Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
15 Jan 2018to 31 Jul 2019
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 10 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Case Western Reserve University

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: 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).

Read the detailed description

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.
Being tested
TRUST Intervention, Enhanced Usual Care
Keywords
magnetic resonance imaging, trust, reward
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRUST InterventionBehavioural

    Also called Trust-building weight Self-management Together

    The TRUST intervention will be guided by Rotenberg's Framework of Interpersonal Trust 3. The TRUST group will meet with an interventionist trained in weight self-management for eight 90-minute weekly sessions. Each session will include adolescent/parent trust-building exercises (honesty, reliability, emotional connection), didactic content, experiential skills developing (nutrition label reading), behavior-change goal-setting, and problem-solving.

  • Enhanced Usual CareBehavioural

    Single meeting with a Nutritionist for physical activity and eating counseling.

Study groups in NCT03016247
Study groupRoleWhat they receive
Enhanced Usual CareActive comparatorGroup will receive a single visit with a Nutritionist for dietary and physical activity counseling
Receives: Behavioral: Enhanced Usual Care
TRUST interventionExperimentalGroup will receive parent-adolescent trust-building and weight self-management training.
Receives: Behavioral: TRUST Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Statistically significant change in BMI from baseline to 3 months and 6 months

    Measured: 6 months

Secondary outcomes (3)
  1. Eating

    Change in Nutrient Data Systems Report data

    Measured: 6 months

  2. Physical Activity

    Change in accelerometer data

    Measured: 6 months

  3. Sleep

    Change in PROMIS-Sleep 4 scale score and Pediatric Daytime Sleepiness Scale score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start15 Jan 2018
  3. Primary completion24 Jun 2019
  4. Study completion31 Jul 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016247
Sponsor's protocol ID
09-16-49
Acronym
TRUST
Status last verified
Nov 2019
First submitted
6 Jan 2017
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared for further analysis after main results are published.

Publications

  • Heinberg LJ, Kutchman EM, Berger NA, Lawhun SA, Cuttler L, Seabrook RC, Horwitz SM. Parent involvement is associated with early success in obesity treatment. Clin Pediatr (Phila). 2010 May;49(5):457-65. doi: 10.1177/0009922809337531. Epub 2009 Jun 1.

    PubMed 19487764
  • Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. doi: 10.1016/j.dr.2007.08.002.

    PubMed 18509515
  • Jack AI, Dawson AJ, Begany KL, Leckie RL, Barry KP, Ciccia AH, Snyder AZ. fMRI reveals reciprocal inhibition between social and physical cognitive domains. Neuroimage. 2013 Feb 1;66:385-401. doi: 10.1016/j.neuroimage.2012.10.061. Epub 2012 Oct 27.

    PubMed 23110882
  • Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

    PubMed 32205788

Questions about this trial

What is this clinical trial studying?

A study testing TRUST Intervention in people with Adolescent Obesity, run by University Hospitals Cleveland Medical Center 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 6 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 2 Dec 2019. 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?

Body Mass Index (time frame: 6 months). 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 NCT03016247, which also lists 4 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 2 Dec 2019.

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