Increased Monitoring of Physical Activity and Calories With Technology
NCT ID: NCT03961061
Last Updated: 2024-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2020-11-04
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brenner FIT (Standard Care)
Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments.
Brenner mFIT (standard care)
Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.
Brenner mFIT (standard care plus mobile health components)
Adolescents will participate in Brenner Families in Training along with their caregiver.
Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT
Brenner mFIT (standard care plus mobile health components)
Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components.
The six mHealth components that will be used in addition to standard Brenner Families in Training program include-
1. a mobile-enabled website,
2. diet and physical activity tracking apps and physical activity tracker
3. tailored self-monitoring feedback
4. caregiver podcasts
5. animated videos for adolescent patients
6. social support via social media.
Interventions
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Brenner mFIT (standard care)
Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.
Brenner mFIT (standard care plus mobile health components)
Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components.
The six mHealth components that will be used in addition to standard Brenner Families in Training program include-
1. a mobile-enabled website,
2. diet and physical activity tracking apps and physical activity tracker
3. tailored self-monitoring feedback
4. caregiver podcasts
5. animated videos for adolescent patients
6. social support via social media.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Justin B Moore, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Brenner Children's Hospital
Winston-Salem, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00058207
Identifier Type: -
Identifier Source: org_study_id
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