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Effect of a Physical Activity Consultation in the Management of Adolescent Overweight (the PAC-MAnO project): study rationale, design and methods.

ABSTRACT: Background:Adolescent overweight is a major public health concern, as it is associated with several short-run and long-run adverse health outcomes. Inappropriate health behaviours may be at the front of this epidemic. There is widespread need for new strategies that may positively influence dietary and physical activity behaviours. This trial (NCT02941770) was designed to investigate the impact of a physical activity consultation, based on motivational interview technique, on physical activity behaviour and weight status among overweight adolescents followed at a tertiary paediatric care centre. Methods/Design:This is an ongoing non-randomised controlled clinical trial with a 6-month duration and follow-up at month 12. It is expected to be concluded in December 2018. Adolescents (n=129) aged 12-18 with a body mass index ?p85 are recruited and allocated into three groups: (1) control group: standard care (paediatric and nutrition consultations, n=43); (2) experimental group I: standard care plus physical activity consultation (n=43); and (3) experimental group II: exposure to two sessions/week of structured physical exercise, in addition to the standard care plus physical activity consultations (n=43). Sample size was calculated according to power analysis. Participants undergo a set of socioeconomic, anthropometric, body composition, clinical and behavioural (dietary and physical activity) assessments. Discussion:Adolescence is a critical period for the acquisition of a healthy lifestyle. The promotion of an active lifestyle may influence adolescents' weight status and further prevent multiple comorbidities. The findings of our study will provide further understanding on the impact of a physical activity consultation on physical activity behaviour and weight reduction/maintenance among overweight adolescents. Trial registration number:NCT02941770.

SUBMITTER: Videira-Silva A

PROVIDER: S-EPMC6069927 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Effect of a Physical Activity Consultation in the Management of Adolescent Overweight (the PAC-MAnO project): study rationale, design and methods.

Videira-Silva Antonio A Sardinha Luís L Fonseca Helena H

BMJ paediatrics open 20180715 1

<h4>Background</h4>Adolescent overweight is a major public health concern, as it is associated with several short-run and long-run adverse health outcomes. Inappropriate health behaviours may be at the front of this epidemic. There is widespread need for new strategies that may positively influence dietary and physical activity behaviours. This trial (NCT02941770) was designed to investigate the impact of a physical activity consultation, based on motivational interview technique, on physical ac ...[more]

PMID: 30094347

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Project description:OBJECTIVE:To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. METHODS:Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. RESULTS:CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CONCLUSIONS:CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. TRIAL REGISTRATION:ClinicalTrials.gov NCT00052078.

Project description:BACKGROUND:Physical activity decreases from childhood through adulthood. Among youth, teenagers (teens) achieve the lowest levels of physical activity, and high school age youth are particularly at risk of inactivity. Effective methods are needed to increase youth physical activity in a way that can be maintained through adulthood. Because teens text a great deal, text messages promoting walking, a low cost physical activity, may be an effective method for promoting sustainable physical activity. OBJECTIVE:The objective of our study was to determine the effect of pedometers, self selected step goals, and texts grounded in the self-determination theory (SDT) on physical activity among the teens. METHODS:"TXT Me!" was a 12 week intervention that texted 14-17 year olds to increase their daily physical activity by increasing the number of steps they take each day. The intervention was grounded in the SDT. Formative research with the teens helped construct the intervention and develop the texts. A total of 84 texts were developed (12 to set a step goal, and 72 promoting autonomy, competence, and relatedness). The pilot evaluation used a four group, randomized design (n=160). After baseline data collection, the participants were randomized to one of four conditions (no treatment control, pedometer only, pedometer + weekly prompts, pedometer + weekly prompts + SDT grounded texts). Data were collected at baseline and immediately upon completion of the study. The primary outcome was physical activity, measured by 7 days of accelerometry. Basic psychological needs, physical activity motivation, process evaluation, and program satisfaction data were also collected. RESULTS:To our knowledge, this is one of the first studies to explore the use of stand alone, SDT grounded texts, supported by pedometers and prompts to set a self selected step goal, as a method for increasing physical activity among teens. CONCLUSIONS:This pilot study will contribute valuable information regarding whether theoretically grounded text messages show promise as an effective method to increase physical activity among teens. TRIAL REGISTRATION:Clinicaltrials.gov NCT01482234; http://clinicaltrials.gov/ct2/show/NCT01482234 (Archived by WebCite at http://www.webcitation.org/6NYvRMOoq).

Project description:BackgroundChronic traumatic encephalopathy (CTE) is a neurodegenerative disease that has been neuropathologically diagnosed in brain donors exposed to repetitive head impacts, including boxers and American football, soccer, ice hockey, and rugby players. CTE cannot yet be diagnosed during life. In December 2015, the National Institute of Neurological Disorders and Stroke awarded a seven-year grant (U01NS093334) to fund the "Diagnostics, Imaging, and Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE) Research Project." The objectives of this multicenter project are to: develop in vivo fluid and neuroimaging biomarkers for CTE; characterize its clinical presentation; refine and validate clinical research diagnostic criteria (i.e., traumatic encephalopathy syndrome [TES]); examine repetitive head impact exposure, genetic, and other risk factors; and provide shared resources of anonymized data and biological samples to the research community. In this paper, we provide a detailed overview of the rationale, design, and methods for the DIAGNOSE CTE Research Project.MethodsThe targeted sample and sample size was 240 male participants, ages 45-74, including 120 former professional football players, 60 former collegiate football players, and 60 asymptomatic participants without a history of head trauma or participation in organized contact sports. Participants were evaluated at one of four U.S. sites and underwent the following baseline procedures: neurological and neuropsychological examinations; tau and amyloid positron emission tomography; magnetic resonance imaging and spectroscopy; lumbar puncture; blood and saliva collection; and standardized self-report measures of neuropsychiatric, cognitive, and daily functioning. Study partners completed similar informant-report measures. Follow-up evaluations were intended to be in-person and at 3 years post-baseline. Multidisciplinary diagnostic consensus conferences are held, and the reliability and validity of TES diagnostic criteria are examined.ResultsParticipant enrollment and all baseline evaluations were completed in February 2020. Three-year follow-up evaluations began in October 2019. However, in-person evaluation ceased with the COVID-19 pandemic, and resumed as remote, 4-year follow-up evaluations (including telephone-, online-, and videoconference-based cognitive, neuropsychiatric, and neurologic examinations, as well as in-home blood draw) in February 2021.ConclusionsFindings from the DIAGNOSE CTE Research Project should facilitate detection and diagnosis of CTE during life, and thereby accelerate research on risk factors, mechanisms, epidemiology, treatment, and prevention of CTE.Trial registrationNCT02798185.

Project description:BackgroundAbout 35 % of non-elderly U.S. adult Medicaid enrollees have a behavioral health condition, such as anxiety, mood disorders, substance use disorders, and/or serious mental illness. Individuals with serious mental illness, in particular, have mortality rates that are 2 to 3 times higher as the general population, which are due to multiple factors including inactivity, poor nutrition, and tobacco use. 61 % of Medicaid beneficiaries with behavioral health conditions also have multiple other co-occurring chronic physical health conditions, which further contributes to morbidity and mortality. The Wellness Incentives and Navigation (WIN) project is one of 10 projects under the Centers for Medicare and Medicaid Services "Medicaid Incentives for the Prevention of Chronic Diseases" Initiative, to "test the effectiveness of providing incentives directly to Medicaid beneficiaries of all ages who participate in prevention programs, and change their health risks and outcomes by adopting healthy behaviors."Methods/designWIN is a three-year randomized pragmatic clinical trial designed to examine the comparative effectiveness of the combined use of personal navigators, motivational interviewing, and a flexible wellness account on cardiovascular risk reduction among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness alone relative to the usual care provided within Medicaid Managed Care. 1250 individuals, identified through Medicaid claims data, were recruited and randomly assigned to an intervention group or control group with outcomes tracked annually. A comparison group was also recruited to help assess the study's internal validity.DiscussionThe primary outcomes are physical and mental health related quality-of-life as measured by the SF-12, and BMI, blood pressure, LDL-C, and Hba1c results for those who are diabetic measured clinically. The purpose of this paper is to present the unique design of the WIN trial prior to results becoming available in hopes of assisting other researchers in conducting community-based randomized pragmatic trials. Outcomes will be assessed through the linkage of patient reported outcomes, health care claims, and electronic health record data.Trial registrationNCT02440906.

Dataset Information

Effect of a Physical Activity Consultation in the Management of Adolescent Overweight (the PAC-MAnO project): study rationale, design and methods.

Publications

Effect of a Physical Activity Consultation in the Management of Adolescent Overweight (the PAC-MAnO project): study rationale, design and methods.

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