Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

<p>Abstract</p> <p>Background</p> <p>Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States.</p> <p>Methods/Design</p> <p>The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy.</p> <p>A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m²have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I), 9 months of continued monthly contact (Phase II) and then 6 months (follow-up) on their own. Safety endpoints include adverse event reporting. Intention-to-treat analysis will be applied to all data.</p> <p>Discussion</p> <p>Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01378806">NCT01378806</a>.</p

International planning directions for provision of mental health services

Internationally, there have been calls for more strategic mental health care delivery. For this to occur, individual countries need to define 'core' mental health services and set evidence-based, country-specific resource targets related to these. Via a web search, we identified 32 current mental health plans from five developed countries. We synthesised descriptive information from these documents, in order to compare profiles of 'core' services, resource targets relating to these services, and rationales for these resource targets. Most plans list 'core' clinical services, typically including a mix of inpatient and community services. Only four plans cite resource targets for these 'core' services, and these are difficult to compare due to different definitional and counting rules. All four provide rationales for the targets, though these vary in strength. The challenge remains for individual countries to develop plans that include appropriate resource targets, and to implement initiatives that move them towards these targets