Randomized controlled trial of a telephone-based intervention for child fruit and vegetable intake: long-term follow-up

Telephone-based interventions can be effective in increasing child fruit and vegetable intake in the short term (<6 mo). The long-term efficacy of such interventions, however, is unknown.

A multifaceted pharmacist intervention to improve antihypertensive adherence: a cluster-randomized, controlled trial (HAPPy trial)

About half of all patients taking antihypertensives discontinue treatment by 12 months. There is potential for substantial health gains at both individual and population levels through improved treatment adherence. The objective was to evaluate a community pharmacist intervention to improve adherence with antihypertensive medicines with a view to improving blood pressure (BP) control.

Protocol and rationale-the efficacy of minocycline as an adjunctive treatment for major depressive disorder: a double blind, randomised, placebo controlled trial

While current pharmacotherapies are efficacious, there remain a clear shortfall between symptom remission and functional recovery. With the explosion in our understanding of the biology of these disorders, the time is ripe for the investigation of novel therapies. Recently depression is conceptualized as an immune-inflammatory and nitro-oxidative stress related disorder. Minocycline is a tetracycline antibiotic that has anti-inflammatory, pro-oxidant, glutamatergic, neurotrophic and neuroprotective properties that make it a viable target to explore as a new therapy. This double blind, randomised, placebo controlled adjunctive trial will investigate the benefits of 200 mg/day of minocycline treatment, in addition to any usual treatment, as an adjunctive treatment for moderate-severe major depressive disorder. Sixty adults are being randomised to 12 weeks of treatment (with a 4 week follow-up post-discontinuation). The primary outcome measure for the study is mean change on the Montgomery-Asberg Depression Rating Scale (MADRS), with secondary outcomes including the Social and Occupational Functioning Assessment Scale (SOFAS), Clinical Global Impressions (CGI), Hamilton Rating Scale for Anxiety (HAM-A), Patient Global Impression (PGI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Range of Impaired Functioning Tool (LIFE-RIFT). Biomarker analyses will also be conducted at baseline and week 12. The study has the potential to provide new treatment targets, both by showing efficacy with a new class of 'antidepressant' but also through the analysis of biomarkers that may further inform our understanding of the pathophysiology of unipolar depression.

Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression

Objective: Bipolar disorder places a significant burden on individuals, caregivers and family, and the broader community. Current treatments are believed to be more effective against manic symptoms, leaving a shortfall in recovery during the depressive phase of the illness. The current study draws on recent evidence suggesting that, in addition to increased oxidative load, alterations in mitochondrial function occur in bipolar disorder. Methods: This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase. Results: The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment. Conclusion: This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression. Trial registration: Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.

Feasibility of conducting a palliative care randomized controlled trial in children with advanced cancer: assessment of the PediQUEST study

Pediatric palliative care randomized controlled trials (PPC-RCTs) are uncommon.

Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention : results from the PediQUEST randomized controlled trial.

This study aimed to determine whether feeding back patient-reported outcomes (PROs) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life (HRQoL).

Caffeine increases sugar-sweetened beverage consumption in a free-living population: a randomised controlled trial

Excessive sugar-sweetened beverage (SSB) consumption has been associated with overweight and obesity. Caffeine is a common additive to SSB, and through dependence effects, it has the potential to promote the consumption of caffeine-containing foods. The objective of the present study was to assess the influence that caffeine has on the consumption of SSB. Participants (n 99) were blindly assigned to either a caffeinated SSB (C-SSB) or a non-caffeinated SSB (NC-SSB) group. Following randomisation, all participants completed a 9 d flavour-conditioning paradigm. They then completed a 28 d ad libitum intake intervention where they consumed as much or as little of C-SSB or NC-SSB as desired. The amount consumed (ml) was recorded daily, 4 d diet diaries were collected and liking of SSB was assessed at the start and end of the intervention. Participants (n 50) consuming the C-SSB had a daily SSB intake of 419 (sd 298) ml (785 (sd 559) kJ/d) over the 28 d intervention, significantly more than participants (n 49) consuming the NC-SSB (273 (sd 278) ml/d, 512 (sd 521) kJ/d) (P< 0·001). A trained flavour panel (n 30) found no difference in flavour between the C-SSB and NC-SSB (P>0·05). However, participants who consumed the C-SSB liked the SSB more than those who consumed the NC-SSB (6·3 v. 6·0 on a nine-point hedonic scale, P= 0·022). The addition of low concentrations of caffeine to the SSB significantly increases the consumption of the SSB. Regulating caffeine as a food additive may be an effective strategy to decrease the consumption of nutrient-poor high-energy foods and beverages.

Individualised, flexible postnatal care: a feasibility study for a randomised controlled trial

Abstract
Background:
Postnatal care in hospital is often provided using defined care pathways, with limited opportunity for more refined and individualised care. We explored whether a tertiary maternity service could provide flexible, individualised early postnatal care for women in a dynamic and timely manner, and if this approach was acceptable to women.
Methods: A feasibility study was designed to inform a future randomised controlled trial to evaluate an alternative approach to postnatal care. English-speaking women at low risk of medical complications were recruited around 26 weeks gestation to explore their willingness to participate in a study of a new, flexible model of care that involved antenatal planning for early postpartum discharge with additional home-based postnatal care. The earlier women were discharged from hospital, the more home-based visits they were eligible to receive. Program uptake was measured, women’s views obtained by a postal survey sent at eight weeks postpartum and clinical data collected from medical records.
Results: Study uptake was 39% (109/277 approached). Most women (n=103) completed a postnatal care plan during pregnancy; 17% planned to leave hospital within 12 hours of giving birth and 36% planned to stay 48 hours. At eight weeks postpartum most women (90%) were positive about the concept and 88% would opt for the same program again. Of the 28% who stayed in hospital for the length they had planned, less than half (43%) received the appropriate number of home visits, and only 41% were given an option for the timing of the visit. Most (62%) stayed in hospital longer than planned (probably due to clinical complications); 11% stayed shorter than planned.
Conclusions: Women were very positive about individualised postnatal care planning that commenced during pregnancy. Given the hospital stay may be impacted by clinical factors, individualised care planning needs to continue into the postnatal period to take into account circumstances which cannot be planned for during pregnancy. However, individualised care planning during the postnatal period which incorporates a high level of flexibility may be challenging for organisations to manage and implement, and a randomised controlled trial of such an approach may not be feasible.

A cluster randomised controlled trial of a telephone-based intervention targeting the home food environment of preschoolers (The Healthy Habits Trial): the effect on parent fruit and vegetable consumption

Abstract
Background: The home food environment is an important setting for the development of dietary patterns in childhood. Interventions that support parents to modify the home food environment for their children, however, may also improve parent diet. The purpose of this study was to assess the impact of a telephone-based intervention targeting the home food environment of preschool children on the fruit and vegetable consumption of parents.
Methods: In 2010, 394 parents of 3 – 5 year – old children from 30 preschools in the Hunter region of Australia were recruited to this cluster randomised controlled trial and were randomly assigned to an intervention or control group. Intervention group parents received four weekly 30-minute telephone calls and written resources. The scripted calls focused on; fruit and vegetable availability and accessibility, parental role-modelling, and supportive home food routines. Two items from the Australian National Nutrition Survey were used to assess the average number of serves of fruit and vegetables consumed each day by parents at baseline, and 2-, 6-, 12-, and 18-months later, using generalised estimating equations (adjusted for baseline values and clustering by preschool) and an intention-to-treat-approach.
Results: At each follow-up, vegetable consumption among intervention parents significantly exceeded that of controls. At 2-months the difference was 0.71 serves (95% CI: 0.58-0.85, p < 0.0001), and at 18-months the difference was 0.36 serves (95% CI: 0.10-0.61, p = 0.0067). Fruit consumption among intervention parents was found to significantly exceed consumption of control parents at the 2-,12- and 18-month follow-up, with the difference at 2-months being 0.26 serves (95% CI: 0.12-0.40, p = 0.0003), and 0.26 serves maintained at 18-months, (95% CI: 0.10-0.43, p = 0.0015).
Conclusions: A four-contact telephone-based intervention that focuses on changing characteristics of preschoolers’ home food environment can increase parents’ fruit and vegetable consumption.
(ANZCTR12609000820202)

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial

Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth, given (1) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life; and (2) the delay in lactogenesis II compared with women without diabetes that increases their infant's risk of receiving infant formula. The Diabetes and Antenatal Milk Expressing (DAME) trial will establish whether advising women with diabetes in pregnancy (pre-existing or gestational) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units (SCN/NICU) compared with infants of women receiving standard care. Secondary outcomes include birth gestation, breastfeeding outcomes and economic impact.

My road ahead study protocol: a randomised controlled trial of an online psychological intervention for men following treatment for localised prostate cancer

There is a need for psychosocial interventions for men with prostate cancer to promote adaptive coping with the challenges and distress associated with diagnosis, treatment and recovery. In addition, interventions are needed that help to overcome barriers to psychosocial treatment such as limited face-to-face psychosocial support services, a shortage of adequately trained professionals, geographical distance, perceived and personal stigma and a preference for consumer-centric and self-directed learning. My Road Ahead is an online cognitive behaviour therapy (CBT) intervention for prostate cancer. This protocol describes a randomised controlled trial (RCT) that will evaluate the efficacy of this online intervention alone, the intervention in combination with a moderated online forum, and the moderated online forum alone.

A randomised controlled trial of an intervention to increase the implementation of a healthy canteen policy in Australian primary schools: study protocol

Background: The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain. Internationally, research suggests that schools often fail to implement practices consistent with healthy school canteen policies. Without a population wide implementation, the potential benefits of these policies will not be realised. The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales (NSW), Australia, government known as the 'Fresh Tastes @ School NSW Healthy School Canteen Strategy'.Methods/design: The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales, Australia. Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy. Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel. Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff, staff training, resources, recognition and incentives, consensus and leadership strategies, follow-up support and implementation feedback. The 35 schools allocated to the control group will not receive any intervention support as part of the research trial. The primary outcome measures will be i) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ('red' and 'banned' items) and ii) the proportion of schools where healthy canteen items ('green' items) represent the majority (>50%) of products listed on the menu. Outcome data will be collected via a comprehensive menu audit, conducted by dietitians blind to group allocation. Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values.Discussion: The proposed trial will represent a novel contribution to the literature, being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy.