Recruitment and Retention of Parents of Adolescents in a Text Messaging Trial (MyTeen): Secondary Analysis From a Randomized Controlled Trial

Background Parenting programs are well established as an effective strategy for enhancing both parenting skills and the well-being of the child. However, recruitment for family programs in clinical and nonclinical settings remains low. Objective This study aims to describe the recruitment and retention methods used in a text messaging program (MyTeen) trial for parents of adolescents (10-15 years) and identify key lessons learned. We aim to provide insights and direction for researchers who seek to recruit parents and build on the limited literature on recruitment and retention strategies for parenting program trials. Methods A recruitment plan was developed, monitored, and modified as needed throughout the course of the project. Strategies to facilitate recruitment were identified (eg, program content and recruitment material, staff characteristics, and study procedures). Traditional and web-based recruitment strategies were used. Results Over a 5-month period, 319 parents or caregivers expressed interest in our study, of which 221 agreed to participate in the study, exceeding our recruitment target of 214 participants. Attrition was low at the 1-month (4.5% overall; intervention group: n=5, 4.6%; control group: n=5, 4.5%) and 3-month follow-ups (9% overall; intervention group: n=10, 9.2%; control group: n=10, 8.9%). Conclusions The use of web-based recruitment strategies appeared to be most effective for recruiting and retaining parents in a text-messaging program trial. However, we encountered recruitment challenges (ie, underrepresentation of ethnic minority groups and fathers) similar to those reported in the literature. Therefore, efforts to engage ethnic minorities and fathers are needed. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12618000117213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374307

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Recruitment and retention: lessons learned from a text messaging trial (MyTeen) for parents of adolescents. (Preprint)

10.2196/preprints.17723 ◽

2020 ◽

Author(s):

Joanna Ting Wai Chu ◽

Angela Wadham ◽

Yannan Jiang ◽

Karolina Stasiak ◽

Matthew Shepherd ◽

...

Keyword(s):

Text Messaging ◽

Intervention Group ◽

Well Being ◽

Lessons Learned ◽

Control Group ◽

Clinical Trial Registry ◽

Recruitment And Retention ◽

Multiple Strategies ◽

Recruitment Challenges ◽

Program Content

BACKGROUND Parenting programs are well established as an effective strategy for enhancing both parenting skills and child well-being. However, recruitment for family programs in clinical and non-clinical settings remains low. OBJECTIVE The aim of the study is to describe the recruitment and retention methods used in a text messaging program (MyTeen) trial for parents of adolescents (10-15) and identify key lessons learned. METHODS A recruitment plan was developed, monitored, and modify as needed throughout the project. Strategies to facilitate recruitment were identified (e.g., program content and recruitment materials, staff characteristics, and study procedures). Traditional and online recruitment strategies were employed. RESULTS Over a 5-month period, 319 parents/caregivers expressed interest in our study, of which 221 participated in our study, exceeding our recruitment target (214 participants). Attrition was low at 1-month (4.5% overall; intervention group: n=5, 4.6%; control group: n=5, 4.5%) and at 3-months follow-up (9% overall; intervention group: n=10, 9.2%; control group: n=10, 8.9%). CONCLUSIONS Using multiple strategies was effective for recruiting and retaining parents in a text-messaging program trial. However, we encountered recruitment challenges (i.e. under representation of ethnic groups and fathers) similar to those reported in the literature. Efforts to engage ethnic minorities and fathers are needed. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (ACTRN12618000117213)

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Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): A Pragmatic Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzaa059_006 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 1289-1289

Author(s):

Hayford Avedzi ◽

Allison Soprovich ◽

Stephanie Ramage ◽

Abdulrhman Alghamdi ◽

Kate Storey ◽

...

Keyword(s):

Nutrition Education ◽

Glycemic Index ◽

Self Efficacy ◽

Text Messaging ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Dietary Intakes ◽

Web Based ◽

Phone Calls

Abstract Objectives Rigorous evidence is needed to support uptake of recommendations to include low glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for people with type 2 diabetes (T2D). We evaluated the effectiveness of a 12-week web-based GI-targeted nutrition education intervention on dietary intakes and GI-related knowledge among adults with T2D. Methods Participants were randomized to a control group (n = 34) that received standard printed copies of Canada's Food Guide and Diabetes Canada's GI resources or an intervention group (n = 33) that received those same materials, plus an online platform with six self-directed learning modules and supplementary print material. Each module consisted of a customized video, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and advice for low-GI shopping, recipes, and cooking tips by a Registered Dietitian. Preferred supports through email, text messaging, phone calls, or postal mail to reinforce participants’ learning were also provided. The primary outcome, average daily dietary GI intake, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin A1c, lipids, systolic blood pressure, body mass index, waist circumference, and computer proficiency, were assessed at baseline and at three months post-intervention. Results Participants (N = 67) were 64% men; mean (standard deviation [SD]) age 69.5 (9.3) years, with mean diabetes duration of 19.0 (13.7) years, BMI 30.1 (5.7) kg/m2 and A1c 7.1 (1.2)% at baseline. Mean daily GI intake decreased in the intervention group by 2.79 (7.77) compared to a 0.76 (6.48) increase in the control group (adjusted mean difference [95% CI]; −3.77 [−6.95, −0.58]). Mean GI knowledge 2.14 [0.59, 3.69], understanding of GI concept 1.65 [0.85, 2.44] and self-efficacy for consuming low-GI foods 1.29 [0.51, 2.07] increased among the intervention group (P < 0.01) compared with the control group. Conclusions Web-based GI-targeted education program improved the quality of carbohydrate consumption among adults with T2D and may have been mediated through increases in knowledge and self-efficacy. Web-based nutrition education may be an effective alternative in this population. Funding Sources Canadian Foundation for Dietetic Research.

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Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/17541 ◽

2020 ◽

Vol 7 (7) ◽

pp. e17541

Author(s):

Matthew Fuller-Tyszkiewicz ◽

Ben Richardson ◽

Keriann Little ◽

Samantha Teague ◽

Linda Hartley-Clark ◽

...

Keyword(s):

Active Control ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Self Esteem ◽

Mobile App ◽

Trial Registration ◽

Control Group ◽

Self Monitoring

Background Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. Objective This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. Methods In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. Results In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=−2.07; P=.04) and depressive symptoms (b=−1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=−1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=−0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). Conclusions This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-021-10627-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mariko Nishikawa ◽

Masaaki Yamanaka ◽

Akira Shibanuma ◽

Junko Kiriya ◽

Masamine Jimba

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Safety Information ◽

Intervention Group ◽

Health And Safety ◽

Trial Registration ◽

Control Group ◽

Internet Portal ◽

Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

10.21203/rs.3.rs-24814/v1 ◽

2020 ◽

Author(s):

Ameer Muhammad ◽

Yasir Shafiq ◽

M Imran Nisar ◽

Benazir Baloch ◽

Amna Tanweer Yazdani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Relative Length ◽

Trial Registration ◽

Control Group ◽

Lactating Women ◽

Randomized Controlled ◽

Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

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A 6-Month Randomized Trial of a Smartphone Application, UControlDrink, in Aiding Recovery in Alcohol Use Disorder

European Addiction Research ◽

10.1159/000519945 ◽

2021 ◽

pp. 1-12

Author(s):

Conor Farren ◽

Aoife Farrell ◽

Aisling Hagerty ◽

Cliodhna McHugh

Keyword(s):

Alcohol Use ◽

Text Messaging ◽

Alcohol Use Disorder ◽

Positive Impact ◽

Controlled Trial ◽

Intervention Group ◽

Heavy Drinking ◽

Smartphone Application ◽

Smartphone App ◽

Control Group

Background and Aims: Alcohol use disorder (AUD) is a substantial problem, causing early death and great economic burden. Research has highlighted the potential positive impact of technological interventions, such as smartphone applications (app) in treatment of AUD. The aim of this study was to explore the effectiveness of a smartphone app, incorporating computerized cognitive behavioural therapy and text messaging support, on alcohol outcomes over 6 months in a post-rehabilitation setting. Methods: A total of 111 participants with AUD were recruited into this randomized controlled trial, following completion of a 30-day rehabilitation programme. The intervention group (n = 54) used the smartphone app “UControlDrink” (UCD) over 6 months with treatment as usual (TAU), and the control group (n = 57) received TAU. All subjects suffered from AUD as the primary disorder, with other major psychiatric disorders excluded. All intervention subjects used the UCD smartphone app in the treatment trial, and all subjects underwent TAU consisting of outpatient weekly support groups. Drinking history in the previous 90 days was measured at baseline and at 3- and 6-month follow-ups. Additional measurements were made to assess mood, anxiety, craving, and motivation. Results were analysed using intention-to-treat analyses. Results: Retention in the study was 72% at 3 months and 52% at 6 months. There was a significant reduction in heavy drinking days in the intervention group relative to TAU over the 6 months, p < 0.02. Conclusions: The UCD smartphone app demonstrates a significant benefit to reducing heavy drinking days over a 6-month post-rehabilitation period in AUD.

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A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17103689 ◽

2020 ◽

Vol 17 (10) ◽

pp. 3689

Author(s):

Ellen van der Gaag ◽

Job van der Palen ◽

Pim Schaap ◽

Mirthe van Voorthuizen ◽

Thalia Hummel

Keyword(s):

Lipid Profile ◽

Subclinical Hypothyroidism ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Thyroid Stimulating Hormone ◽

Control Group ◽

Significant Difference ◽

Scale Scores

Purpose: Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness. Methods: We randomized children aged 1–12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores. Results: In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups (p = 0.98). PedQL fatigue scores for sleep (p = 0.032) and total fatigue scores (p = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI. Conclusion: The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children’s well-being can be improved without medication.

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Efficacy of Integrative Body-Mind-Spirit Group Intervention for Parents of Children With Eczema: A Randomized, Wait-List Controlled Clinical Trial

Research on Social Work Practice ◽

10.1177/1049731520905643 ◽

2020 ◽

Vol 30 (6) ◽

pp. 623-632

Author(s):

Yat-Lui Fung ◽

Hiu-Tin Leung ◽

Celia H. Y. Chan ◽

Bobo H. P. Lau ◽

Cecilia L. W. Chan

Keyword(s):

Psychosocial Intervention ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Empirical Support ◽

Well Being ◽

Control Group ◽

Controlled Clinical Trial ◽

Wait List ◽

Reducing Stress

Objectives: This randomized controlled trial evaluated the effects of a psychosocial intervention developed based on the Integrative Body-Mind-Spirit (IBMS) model that aimed to enhance the well-being of parents of children with eczema. Methods: Ninety-one families were randomly allocated to either the six-session intervention group ( n = 48) or the wait-list control group ( n = 43) and completed the randomized trial. For both groups, a range of psychosocial outcome measures were taken before the intervention (T0), postintervention (T1), and 6 weeks after the intervention (T2). Results: Relative to the control group, the intervention group was significantly improved over time in their levels of perceived stress, depression, and a number of holistic well-being measures, including nonattachment, afflictive ideation, and general vitality. Discussion: The results provided empirical support for an IBMS-informed psychosocial intervention in reducing stress and depression and enhancing well-being among parents of children with eczema.

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