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Trial design We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods The study aimed to recruit 206 male or female...
Background The recruitment of participants into community-based randomized controlled trials studying childhood obesity is often challenging, especially from low-income racial/ethnical minorities and when long-term participant commitments are required. This paper describes strategies used to recruit and enroll predominately low-income racial/ethnic minority parents and children into the Childhood...
Background Insufficient physical activity (PA) is a major public health issue. Whilst PA is an important contributor to disease prevention, engagement in PA decreases with age, particularly among women in socio-economically disadvantaged areas. Research using existing support networks to engage ‘hard to reach’ populations in PA interventions is sparse. We developed and tested the feasibility of a...
Background The International Federation of Gynaecology and Obstetrics (FIGO), in collaboration with the Sri Lankan College of Obstetrics and Gynaecologists (SLCOG), launched an initiative in 2014 to institutionalize immediate postpartum IUD (PPIUD) services as a routine part of antenatal counseling and delivery room services in Sri Lanka. In this study, we evaluate the effect of the FIGO-SLCOG PPIUD...
Background In Denmark, exercise therapy in combination with work modification is the first-choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The...
Background Current population surveys suggest around 20% of Australians meet diagnostic criteria for an alcohol use disorder. However, only a minority seek professional help due to individual and structural barriers, such as low health literacy, stigma, geography, service operating hours and wait lists. Telephone-delivered interventions are readily accessible and ideally placed to overcome these barriers...
Background Growth restriction in the newborn (GRN) can predispose to severe complications including hypoglycemia, sepsis, and necrotizing enterocolitis. Different interventions and treatments, such as feeding strategies, for GRN have specific benefits and risks. Comparing results from studies investigating intervention studies in GRN is challenging due to the use of different baseline and study characteristics...
Background E-mental health has become increasingly popular in interventions for individuals with eating disorders (EDs). It has the potential to offer low-threshold interventions and guide individuals to the needed care more promptly. Featback is such an Internet-based intervention and consists of psychoeducation and a fully automated monitoring and feedback system. Preliminary findings suggest Featback...
Background Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FCCHs), which are small, licensed ECE businesses operated out of the residences of providers, are important settings for promoting child health. However, to date, few interventions to...
Background Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effective treatments. Predicated on promising preclinical and pilot clinical data, this paper presents a rationale and protocol for the trial of N-acetylcysteine (NAC) as a novel anti-craving...
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