A pilot trial examining the absorption of oral forms of folate supplementation in a healthy population: A randomised control trial

Purpose The purpose of this paper is to report the process evaluation of a pilot randomised control trial of an anti-smoking intervention for Malaysian 13-14-year olds, conducted in 2011/2012. It was hypothesised that trained peer supporters would promote non-smoking among classmates through informal conversations. Design/methodology/approach Smoking-related baseline and follow-up questionnaires were administered, seven months apart, to Form 1 students (n=2,118) attending eight schools across two districts in Sabah (Kota Kinabalu; Keningau). Concealed stratified randomisation assigned two schools per district to the control and intervention arms. Control schools received usual care. Intervention schools received usual care and the peer supporter intervention. Peer supporters completed smoking-related knowledge and attitudes questionnaires before and after peer supporter training and peer supporter training evaluation questionnaires. They also discussed the peer supporter training and role in focus groups immediately following training (n=4) and three months later (n=3), and additionally, recorded post-training anti-smoking activity in diaries. Findings The pilot trial found that student recruitment was high (baseline students matched at follow-up n=1,681 (79 per cent of class-registered students). More boys (n=38) than girls (n=35) attended peer supporter training. Post-training, most peer supporters had improved smoking-related knowledge (n=55; 75 per cent) and attitudes (n=57; 78 per cent) and returned diaries (n=49; 67 per cent). Some focus group boys reported they were reluctant peer supporters and/or found resisting smoking difficult. Practical implications Future trials would benefit from outlined modifications to peer supporter selection, recruitment and training and additionally, assessments of context and intervention acceptability and reach. Originality/value Trials of complex public health interventions are scarce in economically developing countries.

Download Full-text

Immunogenicity and Safety of an Intradermal BNT162b2 mRNA Vaccine Booster after Two Doses of Inactivated SARS-CoV-2 Vaccine in Healthy Population

Vaccines ◽

10.3390/vaccines9121375 ◽

2021 ◽

Vol 9 (12) ◽

pp. 1375

Author(s):

Porntip Intapiboon ◽

Purilap Seepathomnarong ◽

Jomkwan Ongarj ◽

Smonrapat Surasombatpattana ◽

Supattra Uppanisakorn ◽

...

Keyword(s):

Vaccine Coverage ◽

Randomised Control Trial ◽

Effective Vaccine ◽

Healthy Population ◽

Suitable Alternative ◽

Full Dose ◽

Vaccine Booster ◽

Fractional Dose ◽

Systemic Side Effects ◽

And Function

Effective vaccine coverage is urgently needed to tackle the COVID-19 pandemic. Inactivated vaccines have been introduced in many countries for emergency usage, but have only provided limited protection. Heterologous vaccination is a promising strategy to maximise vaccine immunogenicity. Here, we conducted a phase I, randomised control trial to observe the safety and immunogenicity after an intradermal boost, using a fractional dosage (1:5) of BNT162b2 mRNA vaccine in healthy participants in Songkhla, Thailand. In total, 91 volunteers who had been administered with two doses of inactivated SARS-CoV-2 (CoronaVac) were recruited into the study, and then randomised (1:1:1) to received different regimens of the third dose. An intramuscular booster with a full dose of BNT162b2 was included as a conventional control, and a half dose group was included as reciprocal comparator. Both, immediate and delayed adverse events following immunisation (AEFI) were monitored. Humoral and cellular immune responses were examined to observe the booster effects. The intradermal booster provided significantly fewer systemic side effects, from 70% down to 19.4% (p < 0.001); however, they were comparable to local reactions with the conventional intramuscular booster. In the intradermal group after receiving only one fifth of the conventional dosage, serum Anti-RBD IgG was halved compared to the full dose of an intramuscular injection. However, the neutralising function against the Delta strain remained intact. T cell responses were also less effective in the intradermal group compared to the intramuscular booster. Together, the intradermal booster, using a fractional dose of BNT162b2, can reduce systemic reactions and provides a good level and function of antibody responses compared to the conventional booster. This favourable intradermal boosting strategy provides a suitable alternative for vaccines and effective vaccine management to increase the coverage during the vaccine shortage.

Download Full-text

Role of GERD in chronic resistant sinusitis (CRS): Results of a prospective, open-label pilot trial

Gastroenterology ◽

10.1016/s0016-5085(01)82110-7 ◽

2001 ◽

Vol 120 (5) ◽

pp. A425-A425

Author(s):

B OLUSOLA ◽

J DIBAISE ◽

J HUERTER ◽

E QUIGLEY

Keyword(s):

Pilot Trial ◽

Open Label

Download Full-text

288: The Men's Eating and Living (Meal) Study: A Multi-Center Pilot Trial of Dietary Intervention for the Treatment of Prostate Cancer

The Journal of Urology ◽

10.1016/s0022-5347(18)30553-6 ◽

2007 ◽

Vol 177 (4S) ◽

pp. 96-97

Author(s):

J. Kellogg Parsons ◽

Vicky Newman ◽

James L. Mohler ◽

John P. Pierce ◽

Electra Paskett ◽

...

Keyword(s):

Prostate Cancer ◽

Dietary Intervention ◽

Pilot Trial ◽

Meal Study

Download Full-text

Morning bright light therapy: a helpful tool for reducing comorbid symptoms of affective and behavioral dysregulation in juvenile depressed inpatients? A pilot trial

Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie ◽

10.1024/1422-4917/a000442 ◽

2017 ◽

Vol 45 (1) ◽

pp. 34-41 ◽

Cited By ~ 4

Author(s):

Sarah Bogen ◽

Tanja Legenbauer ◽

Stephanie Gest ◽

Martin Holtmann

Keyword(s):

Pilot Trial ◽

Secondary Analysis ◽

Bright Light ◽

Light Therapy ◽

Bright Light Therapy ◽

Circadian Phase ◽

Behavioral Dysregulation ◽

Sleep Parameters ◽

Circadian Effect ◽

Dysregulation Profile

Abstract. Objective: In recent years, bright light therapy (BLT) has been used to treat depression and to stabilize circadian rhythms. In this study we evaluated whether it is also helpful for comorbid symptoms of affective and behavioral dysregulation in depressive inpatients. Method: This article reports a secondary analysis comparing two subgroups of depressive participants with comorbid affective and behavioral dysregulation, captured with the dysregulation-profile of the Strengths and Difficulties Questionnaire (SDQ-DP; n = 16 vs. n = 11). Participants were randomly allocated to active BLT (10,000 lux) or control BLT (approx. 100 lux), and received 45 minutes of BLT for 2 weeks. SDQ-DP scores, sleep parameters, and circadian preference were assessed at baseline, after the intervention, and 3 weeks later. Results: No direct effects on SDQ-DP scores were observed. Sleep improved in both conditions. Only in the active BLT condition was a circadian phase advance found. Correlation and regression analyses indicated an indirect, circadian effect for improved SDQ-DP scores. Conclusions: The data of this pilot trial should be considered preliminary and merely descriptive. Further research is warranted. 

Download Full-text

Feasibility of an Exercise Program for Older Depressive Inpatients

GeroPsych ◽

10.1024/1662-9647/a000134 ◽

2015 ◽

Vol 28 (4) ◽

pp. 163-171 ◽

Cited By ~ 3

Author(s):

Andreas Heissel ◽

Anou Vesterling ◽

Stephanie A. White ◽

Gunnar Kallies ◽

Diana Behr ◽

...

Keyword(s):

Major Depressive Disorder ◽

Pilot Trial ◽

Exercise Program ◽

Exercise Group ◽

Neurocognitive Functioning ◽

Control Group ◽

Active Control Group ◽

Major Depressive ◽

Older Inpatients ◽

Relaxation Exercises

Abstract. Twelve older inpatients (M age = 66.8) with Major Depressive Disorder (MDD) participated in this controlled pilot trial either in a physical exercise group (PEG; n = 6; aerobic, strength, and coordination exercises) or an active control group (ACG; n = 6; relaxation exercises) twice a week for four weeks. While depressive symptoms decreased in both groups, reduction of symptoms was significantly larger in the PEG. However, the PEG had higher BDI scores compared to the ACG at pretest. Neurocognitive functioning and brain-derived neurotrophic factor (BDNF) concentration did not change significantly. A four-week exercise program may be a feasible adjunct therapy in older MDD patients but the efficacy of the program needs to be proven with larger samples.

Download Full-text