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Background There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. Methods The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? Results A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. Conclusions We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Direct social contact interventions are known to reduce mental health stigma. Filmed social contact may be equally effective and have practical and cost advantages. To compare the effectiveness of a DVD, a live intervention and a lecture control, in reducing stigma, testing the hypotheses that: (a) DVD and live interventions will be equally effective; and (b) the interventions with social contact (DVD/live) will be more effective than the lecture. Cost-effectiveness, process and acceptability are also assessed. Student nurses were randomised to: (a) watch a DVD of service users/informal carers talking about their experiences, (b) watch a similar live presentation, or (c) attend a lecture. Primary outcomes were changes in attitudes (using the Mental Illness: Clinicians Attitudes Scale, MICA), emotional reactions (using the Emotional Reactions to Mental Illness Scale, ERMIS), intended proximity (using the Reported and Intended Behaviour Scale, RIBS), and knowledge (using the Social Contact Intended Learning Outcomes, SCILO), immediately after the intervention and at 4-month follow-up. For the 216 participants, there were no differences between the DVD and live groups on MICA, ERMIS or RIBS scores. The DVD group had higher SCILO (knowledge) scores. The combined social contact group (DVD/live) had better MICA and RIBS scores than the lecture group, the latter difference maintained at 4 months. The DVD was the most cost-effective of the interventions, and the live session the most popular. Our hypotheses were confirmed. This study supports the wider use of filmed social contact interventions to reduce stigma about mental illness.

Background We conducted a nested randomised trial to evaluate the effect of an educational DVD, providing information about healthy food choices and exercise during pregnancy, on diet and physical activity, among pregnant women who were overweight or obese. Methods We conducted a nested randomised trial within the context of the LIMIT randomised trial. Women were eligible with a singleton pregnancy between 10 and 20 weeks gestation, and body mass index at the time of their first antenatal appointment of ≥25 kg/m 2 . All women who were randomised to the Lifestyle Advice Group of the LIMIT trial received a series of consultations with both research dieticians and research assistants, in addition to standard written dietary and exercise materials (Standard Materials Group). Women randomised to the DVD Group received the same consultations and written materials, and additionally received an educational DVD (DVD Group). The primary study outcome was the Healthy Eating Index. Other study outcomes included physical activity, and gestational weight gain. Women completed a qualitative evaluation of all the materials provided. Results 1,108 women in the LIMIT Lifestyle Advice Group participated in the nested trial, with 543 women randomised to the DVD Group, and 565 women to the Standard Materials Group. Women who received the DVD compared with those who did not, had a higher mean Healthy Eating Index at 36 weeks gestation (73.6 vs 72.3; adjusted mean difference 1.2; 95% CI 0.2 to 2.3; p = 0.02), but not at 28 weeks gestation (73.2 vs 73.5; adjusted mean difference −0.1; 95% CI −1.1 to 0.9; p = 0.82). There were no statistically significant differences in physical activity or total gestational weight gain. While most women evaluated the materials positively, frequency of utilisation was poor. Conclusions Ongoing attention to the delivery of information is required, particularly with the increased use and availability of digital and multi-media interactive technologies. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12607000161426

Background Children in households of lower socioeconomic status (SES) are more likely to be overweight/obese. We aimed to determine if home physical activity (PA) environments differed by SES and to explore home environment mediators of the relation of family SES to children’s PA and sedentary behavior. Methods Participants were 715 children aged 6 to 11 from the Neighborhood Impact on Kids (NIK) Study. Household SES was examined using highest educational attainment and income. Home environment was measured by parent report on a survey. Outcomes were child’s accelerometer-measured PA and parent-reported screen time. Mediation analyses were conducted for home environment factors that varied by SES. Results Children from lower income households had greater media access in their bedrooms (TV 52% vs. 14%, DVD player 39% vs. 14%, video games 21% vs. 9%) but lower access to portable play equipment (bikes 85% vs. 98%, jump ropes 69% vs. 83%) compared to higher income children. Lower SES families had more restrictive rules about PA (2.5 vs. 2.0). Across SES, children watched TV/DVDs with parents/siblings more often than they engaged in PA with them. Parents of lower SES watched TV/DVDs with their children more often (3.1 vs. 2.5 days/week). Neither total daily and home-based MVPA nor sedentary time differed by SES. Children’s daily screen time varied from 1.7 hours/day in high SES to 2.4 in low SES families. Media in the bedroom was related to screen time, and screen time with parents was a mediator of the SES--screen time relationship. Conclusions Lower SES home environments provided more opportunities for sedentary behavior and fewer for PA. Removing electronic media from children’s bedrooms has the potential to reduce disparities in chronic disease risk.

Background Despite almost all babies being breastfed initially, the exclusive breastfeeding rate at six months is less than 30% in China. Improving professionals’ knowledge and practical skill is a key government strategy to increase breastfeeding rates. This study aimed to test the effectiveness of a breastfeeding DVD training method for clinicians on improving their knowledge and confidence in the breastfeeding support skills of teaching mothers Positioning and Attachment (P & A) and Hand Expression (HE). Methods A randomised controlled trial was conducted in three hospitals in Zhejiang province, China in 2014. Participants were recruited before their routine breastfeeding training course and randomly allocated to intervention group (IG) and control group (CG). The 15 min “Breastfeeding: Essential Support Skills DVD” was the intervention for IG and a vaginal delivery DVD was used for CG. All participants completed questionnaires of job information, knowledge and confidence in the two skills before (baseline) and immediately after viewing the DVD (post DVD). Results Out of 210 participants, 191 completed knowledge assessments before and after watching the DVD (IG n  = 96, CG n  = 95), with the response rate of 91.0%. At baseline, there are no significant differences in job variables, total knowledge scores and confident scores. The total knowledge score significantly increased post-DVD for IG (pre-DVD: M = 5.39, SD = 2.03; post-DVD: M = 7.74, SD = 1.71; t (95) = − 10.95, p  < 0.01), but no significant change in total knowledge score for CG between pre- and post-DVD (pre-DVD: M = 5.67, SD = 1.70; post-DVD: M = 5.56, SD = 1.63; t (94) = 0.85). The total confidence scores were significantly higher post-DVD than pre-DVD in IG (pre-DVD: M = 66.49, SD = 11.27; post- DVD: M = 71.81, SD = 9.33; t (68) = − 4.92, p  < 0.01), but no significant difference was seen in CG between pre- and post-DVD total confidence scores (pre-DVD: M = 68.33, SD = 11.08; post-DVD: M = 68.35, SD = 11.40; t (65) = − 0.25). Personal and job variables did not mediate these effects. Conclusions The breastfeeding training DVD improved professionals’ knowledge and confidence of the two breastfeeding support skills. However, the effect on professionals’ practice and on breastfeeding outcomes needs to be examined in the future.

ABSTRACTBackgroundBehavioral treatments reduce anxiety, yet many older adults may not have access to these efficacious treatments. To address this need, we developed and evaluated the feasibility and acceptability of a video-delivered anxiety treatment for older Veterans. This treatment program, BREATHE ( Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment), combines psychoeducation, diaphragmatic breathing, and progressive muscle relaxation training with engagement in activities. MethodsA mixed methods concurrent study design was used to examine the clarity of the treatment videos. We conducted semi-structured interviews with 20 Veterans ( M age = 69.5, SD = 7.3 years; 55% White, Non-Hispanic) and collected ratings of video clarity. ResultsQuantitative ratings revealed that 100% of participants generally or definitely could follow breathing and relaxation video instructions. Qualitative findings, however, demonstrated more variability in the extent to which each video segment was clear. Participants identified both immediate benefits and motivation challenges associated with a video-delivered treatment. Participants suggested that some patients may need encouragement, whereas others need face-to-face therapy. ConclusionsQuantitative ratings of video clarity and qualitative findings highlight the feasibility of a video-delivered treatment for older Veterans with anxiety. Our findings demonstrate the importance of ensuring patients can follow instructions provided in self-directed treatments and the role that an iterative testing process has in addressing these issues. Next steps include testing the treatment videos with older Veterans with anxiety disorders.

Background Older Australians are high consumers of complementary and alternative medicines (CM). To help older people to take an active role in their health, we will develop and evaluate a novel educational intervention to support decision self-efficacy, and improve health literacy skills. Methods The primary hypothesis is that participants receiving a web/DVD plus booklet intervention compared with a booklet-only group will demonstrate an increase in decision self-efficacy. This study is a randomised controlled trial. One hundred and sixty-eight people aged 65 years and older will be recruited from community settings comprising retirement villages and community groups, based in Sydney, Australia. Participants will be randomly allocated to either the education intervention delivered by the Internet or a DVD plus booklet versus a control group (booklet only). The primary outcome measure is CM decision self-efficacy. Secondary outcomes are health literacy, knowledge and attitudes, and change in health-seeking behaviour. Participants’ views on the ease of using the resources, the length of the modules, the amount of information, and participant understanding of the modules will be assessed. Outcomes will be collected on completion of the intervention at 3 weeks, and at a 2-month follow up from trial entry. Discussion This trial has the potential to improve CM health literacy in older Australians. There are no educational resources designed to support decision self-efficacy and improve health literacy amongst older people related to CM. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616000135415 . Registered on 5 February 2016.

Electronic media, particularly television, have long been criticized for their potential impact on children. One area for concern is how early media exposure influences cognitive development and academic achievement. Heather Kirkorian, Ellen Wartella, and Daniel Anderson summarize the relevant research and provide suggestions for maximizing the positive effects of media and minimizing the negative effects. One focus of the authors is the seemingly unique effect of television on children under age two. Although research clearly demonstrates that well-designed, age-appropriate, educational television can be beneficial to children of preschool age, studies on infants and toddlers suggest that these young children may better understand and learn from real-life experiences than they do from video. Moreover, some research suggests that exposure to television during the first few years of life may be associated with poorer cognitive development. With respect to children over two, the authors emphasize the importance of content in mediating the effect of television on cognitive skills and academic achievement. Early exposure to age-appropriate programs designed around an educational curriculum is associated with cognitive and academic enhancement, whereas exposure to pure entertainment, and violent content in particular, is associated with poorer cognitive development and lower academic achievement. The authors point out that producers and parents can take steps to maximize the positive effects of media and minimize the negative effects. They note that research on children's television viewing can inform guidelines for producers of children's media to enhance learning. Parents can select well-designed, age-appropriate programs and view the programs with their children to maximize the positive effects of educational media. The authors' aim is to inform policymakers, educators, parents, and others who work with young children about the impact of media, particularly television, on preschool children, and what society can do to maximize the benefits and minimize the costs.

Objective: Falls, loss of health-related quality of life and physical capacity, reduced participation in activities of daily living, and increased fear of falling are all potential outcomes for older adults discharged from hospital. A low-cost video based exercise programme may address this. Design: This study was a randomized controlled trial with blinded outcomes assessment and a six-month follow-up. Subjects and setting: Participants were older adults (>65 years) using a mobility aid discharged from a tertiary hospital in Brisbane, Australia, without referral for community-based rehabilitation services. Intervention: A digital video disk-based programme encompassing six exercise types each with six levels of difficulty. A home visit from a project physiotherapist was conducted to ensure patient safety. Control group patients received usual care. Main measures: Falls, health-related quality of life, participation in activities of daily living, physical capacity and fear of falling. Results: Study participants (n = 53, 19 intervention, 34 control) experienced decreasing health-related quality of life, several falls (72), and lower levels of participation in activities of daily living over the six-month follow-up. The intervention group did not differ significantly from the control group in terms of the outcomes examined, though a non-significant reduction in the rate of falls was observed. Intervention group participants complied with the exercise programme well during the first two weeks following discharge from hospital but then reduced their compliance levels thereafter. Conclusions: The intervention may be beneficial for reducing the rate of falls in this patient population though further research with a larger sample size is indicated.