Time2bHealthy – An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol

BackgroundThe use of parent-focused internet-based programs for the prevention and treatment of childhood obesity has shown promise but there is an acknowledged gap in parent-focused interventions which target the early childhood stage.MethodsThe aim of this study is to determine the efficacy of Time2bHealthy - an online healthy lifestyle program for parents of preschool-aged children. The program will be evaluated using a two-arm, parallel, randomised controlled design. The 11-week program is underpinned by Social Cognitive Theory and consists of interactive modules on healthy eating, physical activity, screen-time and sleep. The intervention also involves elements of social media, where participants share discuss ideas and experiences and they can interact and obtain information with experts. Time2bHealthy is being compared to a comparison condition. Outcomes include change in BMI (primary outcome), dietary intake, physical activity, sleep, child feeding, parental role-modelling and parent self-efficacy. Process evaluation data, such as adherence and engagement with the online forums, will also be collected.DiscussionTime2bHealthy is the first randomised controlled trial to our knowledge to assess the efficacy of an online parent-focussed healthy lifestyle program for preschool-aged children in changing body mass index. Early childhood is a crucial time for establishing healthy lifestyle behaviours and parents play an important role. This study therefore fills an important gap in the literature. If found to be efficacious, Time2bHealthy has potential for broad-reach access and translation into primary health care services.Trial RegistrationThe study is registered with the Australian and New Zealand Clinical Trials Registry (12616000119493).     

Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes – A randomized controlled trial

BackgroundRacial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes.Methods290 primarily African American adults with poor glycemic control were recruited from the Detroit Veteran's Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms were assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. Participants met face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant's personalized health data (iDecide). Over six months, coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.Results290 participants were enrolled.DiscussionTailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management.     

Growing Right Onto Wellness (GROW): A family-centered,community-based obesity prevention randomized controlled trial for preschool child–parent pairs

Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent–child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., built-environment) and micro (i.e., genetics) level systems that contribute to the childhood obesity epidemic.Six hundred parent–child pairs will be randomized to a 3-year healthy lifestyle intervention or a 3-year school readiness program. Eligible children are enrolled between ages 3 and 5, are from minority communities, and are not obese. The principal site for the GROW intervention is local community recreation centers and libraries.The primary outcome is childhood body mass index (BMI) trajectory at the end of the three-year study period. In addition to other anthropometric measurements, mediators and moderators of growth are considered, including genetics, accelerometry, and diet recall.GROW is a staged intensity intervention, consisting of intensive, maintenance, and sustainability phases. Throughout the study, parents build skills in nutrition, physical activity, and parenting, concurrently forming new social networks. Participants are taught goal-setting, self-monitoring, and problem solving techniques to facilitate sustainable behavior change. The GROW curriculum uses low health literacy communication and social media to communicate key health messages. The control arm is administered to both control and intervention participants.By conducting this trial in public community centers, and by implementing a family-centered approach to sustainable healthy childhood growth, we aim to develop an exportable community-based intervention to address the expanding public health crisis of pediatric obesity.     

Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial

Background

Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws) or conservatively by wearing a splint or a cast. Following both of these approaches, rehabilitation has proven effective to prevent functional limitations and to re-establish normal shoulder function. However, access to these rehabilitation services and compliance tends to be limited in elderly patients due to travelling difficulties caused by their precarious health status and, in some cases, social and marital status. Since the majority of patients with a proximal humerus fracture are elderly, it becomes relevant to find a new way to offer quick, simple and suitable rehabilitation service. Thus, the use of promising alternative approaches, as in-home telerehabilitation, can enhance access to rehabilitation services for such population. The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture.

Methods/Design

In this randomized controlled trial, individuals who have had a proximal humerus fracture treated conservatively at the Centre intégré universitaire de santé et de services sociaux de l’Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l’Estrie CHUS), and who are returning home will be included. Participants will be recruited during their visit to the emergency ward or outpatient clinic by the medical or research team and will then sign the informed consent form if they are interested to participate in the study. We expect to recruit 52 participants (26 per group). Randomization will be done by a random number generator with sealed envelopes. Each patient will be evaluated before the beginning of the rehabilitation (T1), and immediately after the 2-month intervention (T2). The following outcomes will be measured: 1) upper extremity function (Constant Shoulder Score and Disability of the Arm, Shoulder and Hand questionnaire [DASH]); 2) range of motion (conventional goniometer); 3) user satisfaction (Health Care Satisfaction questionnaire); and 4) cost of services to the public healthcare system.The difference between the two groups will be compared using a t-test or a chi-squared test, and through a cost-effectiveness economic analysis.

Discussion

We hypothesize that in-home telerehabilitation will provide a good alternative to conventional rehabilitation, in terms of its efficacy, simplicity, patient satisfaction, and low associated costs.

Trial registration

ClinicalTrials.gov: NCT02425267. April 22^nd, 2015.

     

Design of the FRESH study: A randomized controlled trial of a parent-only and parent–child family-based treatment for childhood obesity

Approximately 1 out of 3 children in the United States is overweight or obese. Family-based treatment (FBT) is considered the gold-standard treatment for childhood obesity, but FBT is both staff and cost intensive. Therefore, we developed the FRESH (Family, Responsibility, Education, Support, & Health) study to evaluate the effectiveness of intervening with parents, without child involvement, to facilitate and improve the child's weight status. Targeting parents directly in the treatment of childhood obesity could be a promising approach that is developmentally appropriate for grade-school age children, highly scalable, and may be more cost effective to administer. The current paper describes the FRESH study which was designed to compare the effectiveness of parent-based therapy for pediatric obesity (PBT) to a parent and child (FBT) program for childhood obesity. We assessed weight, diet, physical activity, and parenting, as well as cost-effectiveness, at baseline, post-treatment, and at 6- and 18-month follow-ups. Currently, all participants have been recruited and completed assessment visits, and the initial stages of data analysis are underway. Ultimately, by evaluating a PBT model, we hope to optimize available child obesity treatments and improve their translation into clinical settings.     

Early aggressive intervention for infantile atopic dermatitis to prevent development of food allergy: a multicenter,investigator-blinded,randomized, parallel group controlled trial (PACI Study)—protocol for a randomized controlled trial

Background

Atopic dermatitis is the first clinical manifestation of the atopic march, with the highest incidence in the first year of life. Those affected often go on to develop other allergic diseases including food allergy, asthma, and allergic rhinitis. Recent evidence suggests that sensitization to foods may occur through a defective skin barrier which is common in atopic dermatitis in early life. We hypothesize that therapeutic aggressive intervention to treat new onset atopic dermatitis may prevent the development of later allergen sensitization, and associated food allergy, asthma, and allergic rhinitis.

Methods

This study is a multi-center, pragmatic, two-parallel group, assessor-blind, superiority, individually randomized controlled trial. Atopic dermatitis infants (N?=?650) 7–13 weeks old who develop an itchy rash within the previous 28 days are randomly assigned to the aggressive treatment or the conventional treatment in a 1:1 ratio. The primary outcome is oral food challenge-proven IgE-mediated hen’s egg allergy at the age of 28 weeks.

Discussion

This is a novel pragmatic RCT study to examine the efficacy of early aggressive treatment for atopic dermatitis to prevent later food allergy. If our hypothesis is correct, we hope that such a strategy might impact on disease prevention in countries where food allergy is common, and that our results might reduce the frequency and associated costs of all food allergies as well as hens egg food allergy. Long-term follow and other similar studies will help to determine whether such a strategy will reduce the burden of other allergic diseases such as asthma and allergic rhinitis.Trial registration UMIN-CTR: UMIN000028043

     

Health coaching to improve self-care of informal caregivers of adults with chronic heart failure – iCare4Me: Study protocol for a randomized controlled trial

BackgroundPersons with chronic heart failure are living longer. These patients typically live in the community and are cared for at home by informal caregivers. These caregivers are an understudied and stressed group.MethodsWe are conducting a two-arm, randomized controlled trial of 250 caregivers of persons with chronic heart failure to evaluate the efficacy of a health coaching intervention. A consecutive sample of participants is being enrolled from both clinic and hospital settings at a single institution affiliated with a large medical center in the northeastern US. Both the intervention and control groups receive tablets programmed to provide standardized health information. In addition, the intervention group receives 10 live coaching sessions delivered virtually by health coaches using the tablets. The intervention is evaluated at 6-months, with self-care as the primary outcome. Cost-effectiveness of the intervention is evaluated at 12-months. We are also enrolling heart failure patients (dyads) whenever possible to explore the effect of caregiver outcomes (self-care, stress, coping, health status) on heart failure patient outcomes (number of hospitalizations and days in the hospital) at 12-months.DiscussionWe expect the proposed study to require 5 years for completion. If shown to be efficacious and cost-effective, our virtual health coaching intervention can easily be scaled to.support millions of caregivers worldwide.     

Rationale and study protocol for the ‘Active Teen Leaders Avoiding Screen-time’ (ATLAS) group randomized controlled trial: An obesity prevention intervention for adolescent boys from schools in low-income communities

IntroductionThe negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are ‘at risk’ of obesity. The aim of this paper is to report the rationale and study protocol for the ‘Active Teen Leaders Avoiding Screen-time’ (ATLAS) obesity prevention intervention for adolescent boys living in low-income communities.Methods/designThe ATLAS intervention will be evaluated using a cluster randomized controlled trial in 14 secondary schools in the state of New South Wales (NSW), Australia (2012 to 2014). ATLAS is an 8-month multi-component, school-based program informed by self-determination theory and social cognitive theory. The intervention consists of teacher professional development, enhanced school-sport sessions, researcher-led seminars, lunch-time physical activity mentoring sessions, pedometers for self-monitoring, provision of equipment to schools, parental newsletters, and a smartphone application and website. Assessments were conducted at baseline and will be completed again at 9- and 18-months from baseline. Primary outcomes are body mass index (BMI) and waist circumference. Secondary outcomes include BMI z-scores, body fat (bioelectrical impedance analysis), physical activity (accelerometers), muscular fitness (grip strength and push-ups), screen-time, sugar-sweetened beverage consumption, resistance training skill competency, daytime sleepiness, subjective well-being, physical self-perception, pathological video gaming, and aggression. Hypothesized mediators of behavior change will also be explored.DiscussionATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities.     

Rationale and study protocol for ‘Switch-off 4 Healthy Minds’ (S4HM): A cluster randomized controlled trial to reduce recreational screen time in adolescents

IntroductionExcessive recreational screen time (i.e., screen use for entertainment) is a global public health issue associated with adverse mental and physical health outcomes. Considering the growing popularity of screen-based recreation in adolescents, there is a need to identify effective strategies for reducing screen time among adolescents. The aim of this paper is to report the rationale and study protocol for the ‘Switch-off 4 Healthy Minds’ (S4HM) study, an intervention designed to reduce recreational screen time among adolescents.MethodsThe S4HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools (N = 322 students) in New South Wales, Australia. The 6-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies. The intervention is grounded in Self-Determination Theory (SDT) and includes the following components: an interactive seminar for students, eHealth messaging, behavioral contract and parental newsletters. All outcomes will be assessed at baseline and at 6-months (i.e., immediate post-test). The primary outcome is recreational screen time measured by the Adolescent Sedentary Activity Questionnaire (ASAQ). Secondary outcomes include: self-reported psychological well-being, psychological distress, global physical self-concept, resilience, pathological video gaming and aggression, and objectively measured physical activity (accelerometry) and body mass index (BMI). Hypothesized mediators of behavior change will also be explored.DiscussionThe S4HM study will involve the evaluation of an innovative, theory-driven, multi-component intervention that targets students and their parents and is designed to reduce recreational screen time in adolescents. The intervention has been designed for scalability and dissemination across Australian secondary schools.