Process evaluation design and tools used in a kindergarten-based, family-involved intervention to prevent obesity in early childhood. The ToyBox-study

Process evaluation (PE) is used for the in-depth evaluation of the implementation process of health promotion programmes. The aim of the current paper was to present the PE design and tools used in the ToyBox-intervention. The PE design was based on a three-step approach, including the identification of ToyBox-specific PE elements (step 1), the development of PE tools and harmonization of procedures (step 2), and the implementation of PE using standardized protocol and tools across the intervention countries (step 3). Specifically, to evaluate the implementation of the intervention, teachers' monthly logbooks were recorded (dose delivered, fidelity, dose received); post-intervention questionnaires were completed by parents/caregivers and teachers (dose received); participation and attrition rates were recorded (recruitment, reach); and audit questionnaires and retrospective information on weather conditions were collected (physical and social environment within which the intervention was implemented). Regarding the teachers' training sessions, the researchers who performed the trainings completed evaluation forms and documented teachers' attendance after each training (dose delivered, fidelity, dose received) and teachers completed evaluation forms after each training (dose received). The PE performed in the ToyBox-intervention may contribute in the evaluation of its effectiveness, guide the revision of the intervention material and provide insights for future health promotion programmes and public health policy.

Designing and implementing a kindergarten-based, family-involved intervention to prevent obesity in early childhood: the ToyBox-study

The development of the ToyBox-intervention was based on the outcomes of the preliminary phase of the ToyBox-study, aiming to identify young children's key behaviours and their determinants related to early childhood obesity. The ToyBox-intervention is a multi-component, kindergarten-based, family-involved intervention with a cluster-randomized design, focusing on the promotion of water consumption, healthy snacking, physical activity and the reduction/ breaking up of sedentary time in preschool children and their families. The intervention was implemented during the academic year 2012–2013 in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and Spain. Standardized protocols, methods, tools and material were used in all countries for the implementation of the intervention, as well as for the process, impact, outcome evaluation and the assessment of its cost-effectiveness. A total sample of 7,056 preschool children and their parents/caregivers, stratified by socioeconomic level, provided data during baseline measurements and participated in the intervention. The results of the ToyBox-study are expected to provide a better insight on behaviours associated with early childhood obesity and their determinants and identify effective strategies for its prevention. The aim of the current paper is to describe the design of the ToyBox-intervention and present the characteristics of the study sample as assessed at baseline, prior to the implementation of the intervention.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial

Background
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes.

Methods/Design
The original protocol was published in Trial s (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion “surgical or medical intervention to treat obesity” has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy.

Three year follow-up of an early childhood intervention: what about physical activity and weight status?

Fundamental movement skills are a correlate of physical activity and weight status. Children who participated in a preschool intervention had greater movement skill proficiency and improved anthropometric measures (waist circumference and BMI z scores) post intervention. Three years later, intervention girls had retained their object control skill advantage. The study purpose was to assess whether at three year follow up a) intervention children were more physically active than controls and b) the intervention effect on anthropometrics was still present.

Mothers' perceptions of Melbourne InFANT Program : informing future practice

Intervention programs to prevent childhood obesity are more likely to be successful when mothers are involved and engaged. Yet programs that involve mothers do not often employ process evaluation to identify aspects of the intervention that participants enjoyed or viewed as useful. The aims of this study were to describe how participants of the Melbourne InFANT Program-an early childhood obesity prevention intervention-engaged in the program and perceived its usefulness. Process evaluation data were collected at multiple time points during and after the intervention, using mixed methods drawing upon both quantitative and qualitative data. Results from short surveys (n = 271) and interview transcripts (n = 26) revealed that the Melbourne InFANT Program was perceived as useful and relevant by most (82-93%) participants. The formats through which the knowledge and skills were delivered were considered concise and effective, and aspects considered particularly useful included group sessions and advice on practical strategies to minimize stress around mealtimes. Findings from this study are important to inform future practice and the development of interventions which are well received by participants.

Online mindfulness-based intervention for late-stage bipolar disorder: pilot evidence for feasibility and effectiveness

OBJECTIVES: People in the late stage of bipolar disorder (BD) experience elevated relapse rates and poorer quality of life (QoL) compared with those in the early stages. Existing psychological interventions also appear less effective in this group. To address this need, we developed a new online mindfulness-based intervention targeting quality of life (QoL) in late stage BD. Here, we report on an open pilot trial of ORBIT (online, recovery-focused, bipolar individual therapy). METHODS: Inclusion criteria were: self-reported primary diagnosis of BD, six or more episodes of BD, under the care of a medical practitioner, access to the internet, proficient in English, 18-65 years of age. Primary outcome was change (baseline - post-treatment) on the Brief QoL.BD (Michalak and Murray, 2010). Secondary outcomes were depression, anxiety, and stress measured on the DASS scales (Lovibond and Lovibond, 1993). RESULTS: Twenty-six people consented to participate (Age M=46.6 years, SD=12.9, and 75% female). Ten participants were lost to follow-up (38.5% attrition). Statistically significant improvement in QoL was found for the completers, t(15)=2.88, 95% CI:.89-5.98, p=.011, (Cohen׳s dz=.72, partial η(2)=.36), and the intent-to-treat sample t(25)=2.65, 95% CI:.47-3.76, (Cohen׳s dz=.52; partial η(2)=.22). A non-significant trend towards improvement was found on the DASS anxiety scale (p=.06) in both completer and intent-to-treat samples, but change on depression and stress did not approach significance. LIMITATIONS: This was an open trial with no comparison group, so measured improvements may not be due to specific elements of the intervention. Structured diagnostic assessments were not conducted, and interpretation of effectiveness was limited by substantial attrition. CONCLUSION: Online delivery of mindfulness-based psychological therapy for late stage BD appears feasible and effective, and ORBIT warrants full development. Modifications suggested by the pilot study include increasing the 3 weeks duration of the intervention, adding cautions about the impact of extended meditations, and addition of coaching support/monitoring to optimise engagement.

A telephone support program to reduce costs and hospital admissions for patients at risk of readmissions: lessons from an evaluation of a complex health intervention

This study aimed to evaluate the effectiveness of a telephone health coaching and support service provided to members of an Australian private health insurance fund-Telephonic Complex Care Program (TCCP)-on hospital use and associated costs. A case-control pre-post study design was employed using propensity score matching. Private health insurance members (n=273) who participated in TCCP between April and December 2012 (cases) were matched (1:1) to members who had not previously been enrolled in the program or any other disease management programs offered by the insurer (n=232). Eligible members were community dwelling, aged ≥65 years, and had 2 or more hospital admissions in the 12 months prior to program enrollment. Preprogram variables that estimated the propensity score included: participant demographics, diagnoses, and hospital use in the 12 months prior to program enrollment. TCCP participants received one-to-one telephone support, personalized care plan, and referral to community-based services. Control participants continued to access usual health care services. Primary outcomes were number of hospital admission claims and total benefits paid for all health care utilizations in the 12 months following program enrollment. Secondary outcomes included change in total benefits paid, hospital benefits paid, ancillary benefits paid, and total hospital bed days over the 12 months post enrollment. Compared with matched controls, TCCP did not appear to reduce health care utilization or benefits paid in the 12 months following program enrollment. However, program characteristics and implementation may have impacted its effectiveness. In addition, challenges related to evaluating complex health interventions such as TCCP are discussed.

A web- and mobile phone-based intervention to prevent obesity in 4-year-olds (MINISTOP): a population-based randomized controlled trial

BACKGROUND: Childhood obesity is an increasing health problem globally. Overweight and obesity may be established as early as 2-5 years of age, highlighting the need for evidence-based effective prevention and treatment programs early in life. In adults, mobile phone based interventions for weight management (mHealth) have demonstrated positive effects on body mass, however, their use in child populations has yet to be examined. The aim of this paper is to report the study design and methodology of the MINSTOP (Mobile-based Intervention Intended to Stop Obesity in Preschoolers) trial.

METHODS/DESIGN: A two-arm, parallel design randomized controlled trial in 300 healthy Swedish 4-year-olds is conducted. After baseline measures, parents are allocated to either an intervention- or control group. The 6- month mHealth intervention consists of a web-based application (the MINSTOP app) to help parents promote healthy eating and physical activity in children. MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive, personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children. Parents also register physical activity and intakes of candy, soft drinks, vegetables as well as fruits of their child and receive feedback through the application. Primary outcomes include body fatness and energy intake, while secondary outcomes are time spent in sedentary, moderate, and vigorous physical activity, physical fitness and intakes of fruits and vegetables, snacks, soft drinks and candy. Food and energy intake (Tool for Energy balance in Children, TECH), body fatness (pediatric option for BodPod), physical activity (Actigraph wGT3x-BT) and physical fitness (the PREFIT battery of five fitness tests) are measured at baseline, after the intervention (six months after baseline) and at follow-up (12 months after baseline).

DISCUSSION: This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children. If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity.

Brief Cognitive Behavioral Intervention in Groups in a Brazilian Assisted Reproduction Program

The study's objective was to assess the effect of a cognitive behavioral group intervention on the pregnancy rates of patients submitted to in vitro fertilization (IVF) techniques or to intracytoplasmic sperm injection (ICSI). The study was conducted on 188 patients, 93 who participated in a group of psychological intervention before the IVF and ICSI procedures and 95 patients submitted to IVF and ICSI during the same period of time, who did not participate in the intervention (control group). Clinical pregnancy was the outcome measure. Demographic and clinical variables were compared between groups in order to assess the group's homogeneity. Participants in the psychological intervention obtained a pregnancy rate of 39.8%, significantly higher than the 23.2% rate of nonparticipants (chi(2) = 6.03, p =.01, odds ratio of 22 (CI: 1.16-4.13). The data suggest that group psychological intervention before IVF and ICSI in order to control stress seems to increase the rate of success of these procedures.

Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program

OBJECTIVES The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. BACKGROUND The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. METHODS We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. RESULTS The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). CONCLUSIONS The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).