Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics.
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ABSTRACT:
SUBMITTER: Simione M
PROVIDER: S-EPMC8411392 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background:Connect for Health is an evidence-based weight management program with clinical- and family-facing components for delivery in pediatric primary care for families of children ages 2 to 12?years. We used the Consolidated Framework for Implementation Research (CFIR) to guide formative work prior to national implementation. The purpose of this study was to describe the process and results of stakeholder engagement and program adaptation. Methods:We used mixed qualitative and quantitative methods to iteratively adapt and optimize the program by assessing needs and perspectives of clinicians and parents, as well as contextual barriers, facilitators, and organizational readiness for the uptake of the proposed program tools and implementation strategies. We conducted interviews with primary care clinicians from four health care organizations in Boston, MA; Denver, CO; and Greenville, SC, and used principles of immersion-crystallization for qualitative analyses. We also conducted surveys of parents of children with a body mass index ? 85th percentile. Results:We reached thematic saturation after 52 clinician interviews. Emergent themes representing the CFIR domains of intervention characteristics, outer and inner setting, and process included (1) importance of evidence-based clinical decision support tools that integrate into the workflow and do not extend visit time, (2) developing resources that respond to family's needs, (3) using multimodal delivery options for family resources, (4) addressing childhood obesity while balancing competing demands, (5) emphasizing patient care rather than documentation and establishing sustainability plans, and (6) offering multiple training methods that incorporate performance feedback. Of the parents surveyed (n = 400), approximately 50% were Spanish-speaking and over 75% reported an annual income < $50,000. Parents affirmed the importance of addressing weight management during well-child visits, being provided with referrals and resources, and offering multiple methods for resource delivery. Decisions about program modifications were made at the program and healthcare-system level and based on stakeholder engagement findings. Modifications included cultural, geographic, and target audience adaptations, as well as varied resource delivery options. Conclusions:To ensure the fit between the Connect for Health program and national implementation settings, adaptations were systematically made through engagement of clinician and parent stakeholders to support adoption, sustainability, and health outcomes. Trial registration:NCT04042493.
| S-EPMC7427919 | biostudies-literature
Project description:BackgroundTo address the evolving needs and context changes due to the COVID-19 pandemic, we adapted Connect for Health, an evidence-based, primary care, pediatric weight management intervention. The objective of this study is to describe the planned adaptation process to ensure continued and equitable program uptake during the pandemic.MethodsGuided by adaptation frameworks, we identified the core functions and forms of Connect for Health and then adapted the intervention in response to a changing healthcare context. We engaged stakeholders and surveyed parents of children with a BMI ≥ 85th percentile and pediatric clinicians and examined their experiences using telehealth for pediatric weight management and needs and preferences. Using multivariable logistic regression, we examined the preferences of parents with limited English proficiency regarding key aspects of pediatric weight management.ResultsWe surveyed 200 parents and 43% had a primary language of Spanish. Parents wanted care to be a combination of in-person and virtual visits (80%). We found that parents with limited English proficiency had a higher odds ratio of affirming in-person visits are better than virtual visits for ensuring their child's health concern can be taken care of (OR: 2.91; 95% CI: 1.36, 6.21), feeling comfortable when discussing personal information (OR: 3.91; 95% CI: 1.82, 8.43), talking about healthy behaviors and setting goals (OR: 3.09; 95% CI: 1.39, 6.90), and talking about mental health and overall well-being (OR: 4.02; 95% CI: 1.83, 8.87) than parents without limited English proficiency. We surveyed 75 clinicians and 60% felt telehealth was a useful tool to provide care for pediatric weight management. Clinicians felt virtual visits did not pose barriers to all aspects of care. Informed by the surveys and stakeholder input, we made clinician- and family-level adaptations while retaining the program's function.ConclusionsBy engaging stakeholders and adapting the program for telehealth, we optimized the reach and fit of Connect for Health to ensure its continued uptake. We have provided a real-world example of how clinical innovations can evolve and how to systematically plan adaptations in response to changing healthcare contexts.Trial registrationClinicaltrials.gov (NCT04042493), Registered on August 2, 2019.
| S-EPMC10652425 | biostudies-literature
Project description:Obesity is an important public health concern with limited effective treatment options. Internet-based technologies offer a cost-effective means to treat obesity. However, most of the online programs have been of short duration, have focused on a limited number of treatment modalities, and have not utilized the potential of coaching as part of the intervention. In this paper, we present the design, methods and participants' baseline characteristics in a real-life internet-based weight management program. Healthy Weight Coaching (HWC) is a 12-month web-based intervention for the management of obesity. The program is based on the Acceptance and Commitment Therapy and includes themes important for weight loss, including diet, physical activity, psychological factors, and sleep. In addition to the automated, interactive program, a personal coach is allocated to each participant. The participants are nationally enrolled through referrals from primary care, occupational health, hospitals, and private health care units. Adult individuals with BMI ?25 kg/m2 without severe complications are included. On a weekly basis, participants submit their weight logs, training sessions, and lifestyle targets to the internet portal and are scheduled to have online discussions with their coaches 26 times over the course of a year. Questionnaires on lifestyle, diet, physical activity, psychological factors, sleep, and quality of life are completed at baseline, 3, 6, 9, and 12 months, and thereafter yearly until 5 years. Additionally, log data on the use of the service and discussions with the coach are collected. The main outcome is weight change from baseline to 12 months. Recruitment to the HWC is ongoing. Baseline data of the participants recruited between Oct 2016 and Mar 2019 (n = 1189) are provided. This research will bring insight into how internet-based technologies can be implemented in the virtual management of obesity. Trial registration:The trial is registered at clinicaltrials.cov (Clinical Trials Identifier NCT04019249).
| S-EPMC7451764 | biostudies-literature
Project description:BackgroundAmong people with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches.ObjectiveThis study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches' knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum.MethodsThe trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing virtual training, and web-based avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies, and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to the clients with SMI. Primary outcomes will be coaches' knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also examine the acceptability, feasibility, and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors.ResultsData collection started in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The expected start of data analyses will occur in March 2023, with primary results submitted for publication in April 2023.ConclusionsCommunity mental health programs may be an ideal setting for implementing an evidence-based weight management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs.Trial registrationClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997.International registered report identifier (irrid)DERR1-10.2196/45802.
| S-EPMC10209790 | biostudies-literature
Project description:BackgroundOver recent decades, the prevalence of pediatric obesity has increased markedly in developed and developing countries, and the impact of obesity on health throughout the lifespan has led to urgent calls for action. Family-based weight management interventions that emphasize healthy lifestyle changes can lead to modest improvements in weight status of children with obesity. However, these interventions are generally short in duration, reported in the context of randomized controlled trials and there are few reports of outcomes of these treatment approaches in the clinical setting. Answering these questions is critical for improving the care of children with obesity accessing outpatient health services for weight management. In response, the CANadian Pediatric Weight management Registry (CANPWR) was designed with the following three primary aims: 1. Document changes in anthropometric, lifestyle, behavioural, and obesity-related co-morbidities in children enrolled in Canadian pediatric weight management programs over a three-year period; 2. Characterize the individual-, family-, and program-level determinants of change in anthropometric and obesity-related co-morbidities; 3. Examine the individual-, family-, and program-level determinants of program attrition.Methods/designThis prospective cohort, multi-centre study will include children (2-17 years old; body mass index ?85(th) percentile) enrolled in one of eight Canadian pediatric weight management centres. We will recruit 1,600 study participants over a three-year period. Data collection will occur at presentation and 6-, 12-, 24-, and 36-months follow-up. The primary study outcomes are BMI z-score and change in BMI z-score over time. Secondary outcomes include anthropometric (e.g., height, waist circumference,), cardiometabolic (e.g., blood pressure, lipid profile, glycemia), lifestyle (e.g., dietary intake, physical activity, sedentary activity), and psychosocial (e.g., health-related quality of life) variables. Potential determinants of change and program attrition will include individual-, family-, and program-level variables.DiscussionThis study will enable our interdisciplinary team of clinicians, researchers, and trainees to address foundational issues regarding the management of pediatric obesity in Canada. It will also serve as a harmonized, evidence-based registry and platform for conducting future intervention research, which will ultimately enhance the weight management care provided to children with obesity and their families.
| S-EPMC4082676 | biostudies-literature
Project description:BackgroundThe prevalence and consequences of obesity among children and adolescents remain a leading global public health concern, and evidence-based, multidisciplinary lifestyle interventions are the cornerstone of treatment. Mobile electronic devices are widely used across socioeconomic categories and may provide a means of extending the reach and efficiency of health care interventions.ObjectiveWe aimed to synthesize the evidence regarding mobile health (mHealth) for the treatment of childhood overweight and obesity to map the breadth and nature of the literature in this field and describe the characteristics of published studies.MethodsWe conducted a systematic scoping review in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews, by searching nine academic databases in addition to gray literature for studies describing acceptability, usability, feasibility, effectiveness, adherence, or cost-effectiveness of interventions assessing mHealth for childhood obesity treatment. We also hand searched the reference lists of relevant articles. Studies aimed at the prevention of overweight or obesity were excluded, as were studies in which mHealth was not the primary mode of treatment delivery for at least one study arm or was not independently assessed. A random portion of all abstracts and full texts was double screened by a second reviewer to ensure consistency. Data were charted according to study characteristics, including design, participants, intervention content, behavior change theory (BCT) underpinning the study, mode of delivery, and outcomes measured.ResultsWe identified 42 eligible studies assessing acceptability (n=7), usability (n=2), feasibility or pilot studies (n=15), treatment effect (n=17), and fidelity (n=1). Change in BMI z-scores or percentiles was most commonly measured, among a variety of dietary, physical activity, psychological, and usability or acceptability measures. SMS, mobile apps, and wearable devices made up the majority of mobile interventions, and 69% (29/42) of the studies specified a BCT used.ConclusionsPediatric weight management using mHealth is an emerging field, with most work to date aimed at developing and piloting such interventions. Few large trials are published, and these are heterogeneous in nature and rarely reported according to the Consolidated Standards of Reporting Trials for eHealth guidelines. There is an evidence gap in the cost-effectiveness analyses of such studies.
| S-EPMC7301268 | biostudies-literature
Project description:BackgroundThe burden of obesity is high among US veterans, yet many face barriers to engaging in in-person, facility-based treatment programs. To improve access to weight-management services, the Veterans Health Administration (VHA) developed TeleMOVE, a home-based, 82-day curriculum that utilizes in-home messaging devices to promote weight loss in VHA patients facing barriers to accessing facility-based services.ObjectiveThe primary aim was to establish preliminary evidence for the program by comparing outcomes for TeleMOVE with standard, facility-based MOVE weight-management services (group, individual modalities) over the evaluation period based on the number of patients enrolled per site and the program's clinical effectiveness, as demonstrated by average weight lost per patient. The secondary aim was to understand factors influencing TeleMOVE implementation variability across demonstration sites to develop recommendations to improve national program dissemination.MethodsWe employed a formative mixed-methods design to evaluate the phased implementation of TeleMOVE at 9 demonstration sites and compare patient- and site-level measures of program uptake. Data were collected between October 1, 2009 and September 30, 2011. Patient-level program outcomes were extracted from VHA patient care databases to evaluate program enrollment rates and clinical outcomes. To assess preliminary clinical effectiveness, weight loss outcomes for veterans who enrolled in TeleMOVE were compared with outcomes for veterans enrolled in standard MOVE! at each demonstration site, as well as with national averages during the first 2 years of program implementation. For the secondary aim, we invited program stakeholders to participate in 2 rounds of semistructured interviews about aspects of TeleMOVE implementation processes, site-level contextual factors, and program delivery. Twenty-eight stakeholders participated in audio-recorded interviews.ResultsAlthough stakeholders at 3 sites declined to be interviewed, objective program uptake was high at 2 sites, delayed-high at 2 sites, and low at 5 sites. At 6 months post enrollment, the mean weight loss was comparable for TeleMOVE (n=417) and MOVE! (n=1543) participants at -5.2 lb (SD 14.4) and -5.1 lb (SD 12.2), respectively (P=.91). All sites reported high program complexity because TeleMOVE required more staff time per participant than MOVE! due to logistical and technical assistance issues related to the devices. High-uptake sites overcame implementation challenges by leveraging communication networks with stakeholders, adapting the program to patient needs whenever possible, setting programmatic goals and monitoring feedback of results, and taking time to reflect and evaluate on delivery to foster incremental delivery improvements, whereas low-uptake sites reported less leadership support and effective communication among stakeholders.ConclusionsThis implementation evaluation of a clinical telehealth program demonstrated the value of partnership-based research in which researchers not only provided operational leaders with feedback regarding the effectiveness of a new program but also relevant feedback into contextual factors related to program implementation to enable adaptations for national deployment efforts.
| S-EPMC6307696 | biostudies-literature
Project description:Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively. Whereas LAUNCH was designed as a skills based intervention, MI focused on addressing the guardian's motivation to make changes in diet and activity and providing tools to do so at the guardian's level of readiness to implement changes. Child body mass index z-score was the primary outcome, assessed at pretreatment, posttreatment (Month 6), and 6 and 12month follow-ups (Months 12 and 18). Mechanisms of weight change (e.g., dietary intake, physical activity) and environmental factors associated with weight (e.g., foods available in the home, caregiver diet) were also assessed. This study is unique because it is one of the few randomized controlled trials to examine a developmentally informed, clinic and home skills based behavioral family intervention for preschoolers who are already obese. Being obese during the preschool years increases the likelihood of remaining obese as an adult and is associated with serious health conditions; if this intervention is successful, it has the potential to change the health trajectories for young children with obesity.
| S-EPMC6309338 | biostudies-other
Project description:IntroductionChildhood obesity is a serious public health concern. Multidisciplinary pediatric weight management programs have been deemed effective. However, effectiveness of these programs is impacted by attrition, limiting health benefits to children, and inefficiently utilizing scarce resources.MethodsWe have developed a model (the Outcomes Forecasting System, OFS) that isolates variables associated with attrition from pediatric weight management, with the potential to forecast participant dropout. In Aim 1, we will increase the power and precision of the OFS and then validate the model through the consistent acquisition of key patient, family, and treatment data, from three different weight management sites. In Aim 2, external validity will be established through the application of the OFS at a fourth pediatric weight management program. Aim 3 will be a pilot clinical trial, incorporating an intervention built on the results of Aims 1 and 2 and utilizing the OFS to reduce attrition.DiscussionA greater understanding of the patient, family, and disease-specific factors that predict dropout from pediatric weight management can be utilized to prevent attrition. The goal of the current study is to refine the OFS to a level of precision and efficiency to be a valuable tool to any weight management program. By identifying the most pertinent factors driving attrition across weight management sites, new avenues for treatment will be identified. This study will result in a valuable forecasting tool that will be applicable for diverse programs and populations, decrease program costs, and improve patient retention, adherence, and outcomes.Clinicaltrialsgov identifierNCT04364282.
| S-EPMC8209185 | biostudies-literature
Project description:Objective: We aimed to evaluate the fidelity and estimate the effectiveness of a novel health system employee weight-management program. Methods: Employees participating in a weight loss program consisting of self-monitoring, health coaching and meal replacements optionally enrolled in the 12-month study. Longitudinal, single-arm analyses were conducted evaluating change over time via survey, claims and programmatic data. Token participation incentives were offered for survey completion. Results: In total, 140 participants enrolled (51.2 ± 9.8 years; BMI = 33.2 ± 6.5 kg/m2; 89.3% female). During 1 year, participants attended 18.0 ± 12.2 coaching appointments and self-reported significant improvements in weight (-8.2 ± 10.5% body weight), BMI (-3.9 ± 6.5 kg/m2), fruit/vegetable intake, home food preparation, added sugar, sugar sweetened beverages and life satisfaction (all p < 0.05). No significant changes were reported in physical activity, weight-related social support, self-efficacy or healthcare utilization (all p > 0.05). Conclusions: The findings from this evaluation establish implementation fidelity. Clinically significant self-reported weight loss, coupled with improvements in many weight-related behaviors, suggest the program is an effective weight management tool when offered as an employee well-being program.
| S-EPMC8199381 | biostudies-literature