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      A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study


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          Severe obesity among youths (BMI for age≥120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment.


          This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program.


          Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points.


          This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021.


          The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial.

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          Most cited references39

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          Prevalence and trends in obesity and severe obesity among children in the United States, 1999-2012.

          Childhood obesity is the focus of public health efforts and accurate estimates of the prevalence and severity of obesity are needed for policy decisions and directions for future research. To examine the prevalence of obesity and severe obesity over time for 14 years of the continuous National Health and Nutrition Examination Survey, 1999 to 2012, and to examine differences in the trends by age, race/ethnicity, and sex. Representative sample (N = 26 690) of children in the United States, ages 2 to 19 years, in repeated cross-sections of the National Health and Nutrition Examination Survey, 1999 to 2012. Prevalence of overweight (body mass index [BMI] ≥ 85th percentile), obesity (BMI ≥ 95th percentile for age and sex), class 2 obesity (BMI ≥ 120% of the 95th percentile or BMI ≥ 35), and class 3 obesity (BMI ≥ 140% of the 95th percentile or BMI ≥ 40). From 2011 to 2012, 17.3% (95% CI, 15.3-19.3) of children in the United States aged 2 to 19 years were obese. Additionally, 5.9% (95% CI, 4.4-7.4) of children met criteria for class 2 obesity and 2.1% (95% CI, 1.6-2.7) met criteria for class 3 obesity. Although these rates were not significantly different from 2009 to 2010, all classes of obesity have increased over the last 14 years. Nationally representative data do not show any significant changes in obesity prevalence in the most recently available years, although the prevalence of obesity may be stabilizing. Continuing research is needed to determine which, if any, public health interventions can be credited with this stability. Unfortunately, there is an upward trend of more severe forms of obesity and further investigations into the causes of and solutions to this problem are needed.
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            Performance of the Automated Self-Administered 24-hour Recall relative to a measure of true intakes and to an interviewer-administered 24-h recall.

            The Automated Self-Administered 24-hour Recall (ASA24), a freely available Web-based tool, was developed to enhance the feasibility of collecting high-quality dietary intake data from large samples.
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              The level and tempo of children's physical activities: an observational study.

              We develop an observation system that quantifies the duration, intensity, and frequency of children's physical activities. We use this system to assess the level and tempo of energy expenditure under free-ranging, natural conditions experienced by 15 children aged 6-10 yr in southern California. Observations were recorded every 3 s during 4-h time blocks from 8:00 a.m.-8:00 p.m. Agreement among observers using the coding system was 91%. Using indirect calorimetry, calibration studies in the laboratory determined VO2 (ml.min-1.min-1) during each coded activity, and activities were categorized by intensity (low, medium, or high). Subjects were found to engage in activities of low intensity 77.1% of time and activities of high intensity 3.1% of time. The median duration of low and medium intensity activities was 6 s, of high intensity activities only 3 s with 95% lasting less than 15 s. Children engaged in very short bursts of intense physical activity interspersed with varying intervals of low and moderate intensity. These findings may be important for discovering how children's activity patterns under natural conditions influence physiological processes leading to growth and development. This study demonstrates the advantages of using an observational system that captures more than the intensity and frequency of children's activities to include duration and the length of intervals between activities of varying intensity.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                June 2020
                5 June 2020
                : 9
                : 6
                : e18098
                [1 ] Department of Implementation Science Division of Public Health Sciences Wake Forest School of Medicine Winston-Salem, NC United States
                [2 ] Department of Plastic Surgery Wake Forest School of Medicine Winston-Salem, NC United States
                [3 ] Department of Pediatrics Wake Forest School of Medicine Winston-Salem, NC United States
                [4 ] Department of Internal Medicine Wake Forest School of Medicine Winston-Salem, NC United States
                [5 ] Department of Interdisciplinary Health Sciences Augusta University Augusta, GA United States
                [6 ] Department of Health Promotion, Education & Behavior Arnold School of Public Health University of South Carolina Columbia, SC United States
                [7 ] Office of Operations and Accreditation Arnold School of Public Health University of South Carolina Columbia, SC United States
                [8 ] Department of Biostatistics & Data Science Division of Public Health Sciences Wake Forest School of Medicine Winston-Salem, NC United States
                Author notes
                Corresponding Author: Justin B Moore jusmoore@ 123456wakehealth.edu
                Author information
                ©Justin B Moore, Joshua R Dilley, Camelia R Singletary, Joseph A Skelton, David P Miller Jr, Vahé Heboyan, Gianluca De Leo, Gabrielle Turner-McGrievy, Matthew McGrievy, Edward H Ip. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.06.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 3 February 2020
                : 17 February 2020
                : 27 February 2020
                : 29 February 2020

                physical activity,obesity,adolescence,adult,therapy, family,mobile phone


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