Dataset Information

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

ABSTRACT:

Background

South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes.

Methods

This is a prospective, multicentre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in three provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18?years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in three different health districts in South Africa. Participants randomised individually to the intervention arm will receive three MI counselling sessions one?month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use, and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at the three-month and six-month follow-ups.

Discussion

This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of lifestyle, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost-effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings.

Trial registration

ISRCTN Registry, ISRCTN62728852. Registered on 13 April 2018.

SUBMITTER: Moriarty AS

PROVIDER: S-EPMC6660690 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

Moriarty Andrew Stephen AS Louwagie Goedele Maria GM Mdege Noreen Dadirai ND Morojele Neo N Tumbo John J Omole Olufemi Babatunde OB Bachmann Max Oscar MO Kanaan Mona M Turner Astrid A Parrott Steve S Siddiqi Kamran K Ayo-Yusuf Olalekan Abdulwahab OA

Trials 20190726 1

<h4>Background</h4>South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventi ...[more]

PMID: 31349850

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Project description:BackgroundIn order to define the onset of a new episode of low back pain (LBP), the definition of a "non-episode" must be clear. De Vet et al reviewed the scientific literature but found no evidence-based definitions of episodes or non-episodes of LBP. However, they suggested that pain-based episodes should be preceded and followed by a period of at least one month without LBP. As LBP is an episodic disease, it is not clear whether a sufficient number of patients with LBP will be LBP-free for at least one month ("non-episode") to justify the use of this duration in the definition of pain free episode.ObjectivesTwo clinical populations were followed weekly over one year making it possible 1) to determine the maximum numbers in a row of weeks without LBP, 2) to determine the prevalence of non-episodes throughout a one-year period, and 3) to find the prevalence of patients who reported to be in a non-episode of LBP at the end of the study.MethodsSecondary data were used from two recent clinical studies, in which weekly automated text messages (SMSes) had been collected on the number of days with LBP in the preceding week for one year. Weeks with 0 days of LBP were defined as "zero-weeks" and four zero-weeks in a row were defined as a period without LBP (a"non-episode") according to de Vet et al's suggestion. The study participants, all from the secondary care sector, consisted of: study 1) patients with LBP and Magnetic Resonance Imaging-identified Modic changes and study 2) patients without obvious acute disc problems, Modic changes or other pathologies, who therefore were assumed to have non-specific LBP. Both studies were two-armed intervention studies without a significant difference in outcome between intervention groups. The number of zero-weeks was identified in each participant. Thereafter the numbers of participants who reported at least one non-episode during the study period were identified. Finally, the numbers of participants who had a non-episode at the end of the study were counted. Estimates are reported with their 95% confidence intervals.ResultsThe numbers of participants included in the analyses were 80 and 209. Most commonly, no zero weeks were reported, by 65% (55-75) and 56% (49-63) of patients, respectively. The percentages of study participants with at least one non-episode at some time during the course of the study were 20% (11-29) and 18% (15-21. The percentages of participants who were identified as being in a non-episode at the time of the last week of the study were, 5% (95% CI: 0-10) and 4% (1-7) respectively.ConclusionsThe vast majority of these secondary care sector patients had a profile of more or less constant LBP. The estimates for non-episodes during the study period and at the end of the study were very similar for participants with LBP who also had Modic changes and those with non-specific LBP. It is possible that a definition of pain-free periods is pointless in patients seeking care in the secondary care sector.

Project description:BackgroundObesity is an endemic problem with significant health and financial consequences. Text messaging has been shown to be a simple and effective method of facilitating weight reduction. In addition, waist-to-hip ratio (WHR) has emerged as a significant anthropometric measure. However, few studies have examined the effect of serial anthropometric self-measurement combined with text messaging.ObjectiveThe primary aim of this study was to assess whether an 8-week program, consisting of weekly serial self-measurements of waist and hip circumference, combined with motivational text messages, could reduce WHR among Australian workers.MethodsThis was a community-based, participant-blinded, staggered-entry, parallel group study. Adult workers with access to mobile phones were eligible and recruited through an open access Web-based survey. Participants were randomly allocated to receive intervention or control messages for 8 weeks. Outcome data were self-assessed through a Web-based survey.ResultsA total of 60 participants were randomized with 30 participants each allocated to a control and an intervention group. There was no significant change in WHR (P=.43), and all secondary outcome measures did not differ between the intervention group and the control group at the end of the 8-week intervention. Both groups, however, showed a significant decrease in burnout over time (mean [SE]: pre 4.80 [0.39] vs post 3.36 [0.46]; P=.004). The intervention uptake followed a downward trend. Peak participant replies to weekly self-measurements were received in week 3 (14/23, 61%) and the least in week 8 (8/23, 35%). No harm was found to result from this study.ConclusionsThis study is an innovative pilot trial using text messaging and serial anthropometric measurements in weight management. No change was detected in WHRs in Australian workers over 8 weeks; therefore, it could not be concluded whether the intervention affected the primary outcome. However, these results should be interpreted in the context of limited sample size and decreasing intervention uptake over the course of the study. This pilot trial is useful for informing and contributing to the design of future studies and the growing body of literature on serial self-measurements combined with text messaging.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616001496404; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371696&isReview=true (Archived by WebCite at http://www.webcitation.org/73UkKFjSw).

Project description:BACKGROUND:Calcium is an important nutrient for the attainment of peak bone mass during adolescence and young adulthood. However, these life phases are characterized as hard to reach for health promotion. Social media platforms offer a promising channel as they are relatively low cost but used ubiquitously by youth. OBJECTIVE:The aim of the CAlcium Nutrition-Dietary Opportunities (CAN-DO) study was to conduct a randomized controlled trial to test the effectiveness of Facebook alone or with text messaging as channels to deliver a theory-based program to encourage optimal calcium intake. METHODS:The intervention was a 3-arm parallel trial. Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial. Participants were randomized to 1 of the 3 arms (ie, Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake). The primary outcome was change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods. Changes were assessed before and after the intervention, and the differences in change between groups were compared using multivariate regression models with multiple imputations for missing data. RESULTS:A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study. At the end of the program, no increase in milk intake (odds ratio [OR] 1.51, 95% CI 0.61-3.75 Facebook; OR 1.77, 95% CI 0.74-4.24 Facebook plus text messages; P=.41) nor calcium-rich food was detected (P=.57). There was a significant improvement in knowledge in the Facebook plus text messages group (P<.001), but habit formation improved less than that in the other 2 groups (P=.01). Our results showed a moderate level of engagement with intervention content and positive qualitative feedback from participants. CONCLUSIONS:The CAN-DO study delivered via Facebook (with the additional support of text messages) was found to improve knowledge and was acceptable among young adults. However, further research is needed to better understand social media engagement and how to optimize the program for participants to be sufficiently motivated to increase their intake of calcium-rich foods. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12620000097943; http://www.anzctr.org.au/ACTRN12620000097943.aspx.

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Dataset Information

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

Background

Methods

Discussion

Trial registration

Publications

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial.

Similar Datasets

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