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"Medicine, Preventive Methods."
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A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial
Aims/hypothesisThis randomised controlled trial was performed in India and the UK in people with prediabetes to study whether mobile phone short message service (SMS) text messages can be used to motivate and educate people to follow lifestyle modifications, to prevent type 2 diabetes.MethodsThe study was performed in people with prediabetes (n = 2062; control: n = 1031; intervention: n = 1031) defined by HbA1c ≥42 and ≤47 mmol/mol (≥6.0% and ≤6.4%). Participants were recruited from public and private sector organisations in India (men and women aged 35–55 years) and by the National Health Service (NHS) Health Checks programme in the UK (aged 40–74 years without pre-existing diabetes, cardiovascular disease or kidney disease). Allocation to the study groups was performed using a computer-generated sequence (1:1) in India and by stratified randomisation in permuted blocks in the UK. Investigators in both countries remained blinded throughout the study period. All participants received advice on a healthy lifestyle at baseline. The intervention group in addition received supportive text messages using mobile phone SMS messages 2–3 times per week. Participants were assessed at baseline and at 6, 12 and 24 months. The primary outcome was conversion to type 2 diabetes and secondary outcomes included anthropometry, biochemistry, dietary and physical activity changes, blood pressure and quality of life.ResultsAt the 2 year follow-up (n = 2062; control: n = 1031; intervention: n = 1031), in the intention-to-treat population the HR for development of type 2 diabetes calculated using a discrete-time proportional hazards model was 0.89 (95% CI 0.74, 1.07; p = 0.22). There were no significant differences in the secondary outcomes.Conclusions/interpretationThis trial in two countries with varied ethnic and cultural backgrounds showed no significant reduction in the progression to diabetes in 2 years by lifestyle modification using SMS messaging.Trial registrationThe primary study was registered on www.ClinicalTrials.gov (India, NCT01570946; UK, NCT01795833).FundingThe study was funded jointly by the Indian Council for Medical Research and the UK Medical Research Council.
Journal Article
A mixed methods process evaluation of the implementation of a peer coaching intervention to improve the execution of preventive tasks by occupational physicians
Objectives
This study aimed to evaluate the process of implementation of a peer coaching intervention program for occupational physicians (OPs) to improve the execution of preventive tasks. Specifically, the evaluation seeks to: (1) describe the reach and uptake of the intervention program; (2) determine the extent to which the program was implemented as intended; (3) provide insights into experiences of OPs, and (4) identify factors influencing the implementation.
Methods
This study employed a mixed-methods design. To address the four research aims, seven process indicators were used: acceptability, adoption, appropriateness, feasibility, fidelity, penetration and sustainability. Data were collected between March and June 2024 by means of an online questionnaire (
N
= 98), and 17 semi-structured interviews with group coordinators and OPs. The questionnaire included questions on attendance and reasons for non-attendance, experiences, and ratings of several aspects of the intervention program. Interviews focused on why and how OPs participated, experiences with the intervention program and how it can be improved, and how attention to prevention can be sustained.
Results
Reach and uptake: 20 out of 21 groups allocated to the intervention program participated in the intervention and 98 out of 115 participants (85%) filled in the questionnaire. Three-quarters of the participants completed the entire program. Implementation as intended: 96% of the OPs successfully discussed barriers to the execution of preventive tasks, and 83% were able to formulate strategies for these barriers. Barriers and facilitators: Most participants managed to implement their formulated goals in practice. When they were unable to do so, time constraints and resistance from employers and their occupational health services often played a role. Participants’ experiences: OPs valued the program’s structure, interaction with colleagues, and the increased awareness it generated.
Discussion and conclusion
The peer coaching group program was well-implemented and positively evaluated by OPs. The program can be improved by allocating more time to it, for instance by integrating it into the educational curriculum, and by paying more attention to the specific working conditions of OPs, such as the different sectors in which they are employed.
Trial registration
ISRCTN registry; ISRCTN15394765. Registered on 27 June 2023.
Journal Article
Patient factors affecting successful linkage to treatment in a cervical cancer prevention program in Kenya: A prospective cohort study
To identify patient factors associated with whether women who screened positive for high-risk human papillomavirus (hrHPV) successfully accessed treatment in a cervical cancer prevention program in Kenya.
A prospective cohort study was conducted as part of a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya from January 2018 to February 2019. In this larger trial, women underwent hrHPV testing during community health campaigns (CHCs), and hrHPV+ women were referred to government facilities for cryotherapy. For this analysis, we looked at rates of and predictors of presenting for treatment and presenting within 30 days of receiving positive hrHPV results (\"timely\" presentation). Data came from questionnaires completed at the time of screening and treatment. Multivariable logistic regression was used to identify factors associated with each outcome.
Of the 505 hrHPV+ women, 266 (53%) presented for treatment. Cryotherapy was performed in 236 (89%) of the women who presented, while 30 (11%) were not treated: 15 (6%) due to gas outage, six (2%) due to pregnancy, five (2%) due to concern for cervical cancer, and four (2%) due to an unknown or other reason. After adjusting for other factors in the multivariable analysis, higher education level and missing work to come to the CHC were associated with presenting for treatment. Variables that were associated with increased likelihood of timely presentation were missing work to come to the CHC, absence of depressive symptoms, told by someone important to come to the CHC, and shorter distance to the treatment site.
The majority of hrHPV+ women who did not get treated were lost at the stage of decision-making or accessing treatment, with a small number encountering barriers at the treatment sites. Patient education and financial support are potential areas for intervention to increase rates of hrHPV+ women seeking treatment.
Journal Article
Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial
Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care.
We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention).
Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03).
Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. Trial registration: ClinicalTrials.gov, no. NCT00931788
Journal Article
A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation
Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.
Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm2. Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.
The 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.
While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.
Journal Article
Video-Based Approach to Engaging Parents into a Preventive Parenting Intervention for Divorcing Families: Results of a Randomized Controlled Trial
The public health impact of evidence-based, preventive parenting interventions has been severely constrained by low rates of participation when interventions are delivered under natural conditions. It is critical that prevention scientists develop effective and feasible parent engagement methods. This study tested video-based methods for engaging parents into an evidence-based program for divorcing parents. Three alternative versions of a video were created to test the incremental effectiveness of different theory-based engagement strategies based on social influence and health behavior models. A randomized controlled trial was conducted to compare the three experimental videos versus two control conditions, an information-only brochure and an information-only video. Participants were attendees at brief, court-mandated parent information programs (PIPs) for divorcing or never married, litigating parents. Of the 1123 eligible parents, 61% were female and 13% were never married to the child’s other parent. Randomization to one of five conditions was conducted at the PIP class level, blocking on facilitator. All participants completed a 15-item, empirically validated risk index and an invitation form. Results of regression analyses indicated that the most streamlined version, the core principles video, significantly increased parents’ interest in participating in the parenting intervention, enrollment during a follow-up call, and initiation (i.e., attending at least one session) compared to one or the other control conditions. Findings suggest that videos based on social influence and health behavior theories could provide an effective and feasible method for increasing parent engagement, which would help maximize the public health benefits of evidence-based parenting interventions.
Journal Article
Optimal predictive low glucose management settings during physical exercise in adolescents with type 1 diabetes
Objectives To assess the optimal setting of the predictive low glucose management (PLGM) algorithm for preventing exercise‐induced hypoglycemia in adolescents with type 1 diabetes. Methods Thirty‐four adolescents, 15 to 20 years, wearing PLGM system, were followed during 3 days exercise during a diabetes camp. PLGM threshold was set at 70 mg/dL between 8 am and 10 pm and 90 mg/dL during 10 pm and 8 am Adolescents were divided into group A and B, with PLGM threshold at 90 and 70 mg/dL, respectively, during exercise. Time spent in hypoglycemia and AUC for time slots 8 am to 1 pm, 1 to 4 pm, 4 to 11 pm, 11 pm to 3 am, 3 to 8 am, in 3 days were compared between groups by Wilcoxon rank sum test. Results We analyzed 31 patients (median age 15.0 years, 58.1% males, median diabetes duration 7.0 years, hemoglobin A1c [HbA1c] 7.1%). No significant difference has been observed in time spent in hypoglycemia between groups using threshold 70 or 90. Time spent in target was similar in both groups, as well as time spent in hypo or hyperglycemia. The trends of blood glucose over the 3 days in the 2 groups over‐lapped without significant differences. Conclusions A PLGM threshold of 90 mg/dL during the night was associated with reduced time in hypoglycemia in adolescents doing frequent physical exercise, while maintaining 65.1% time in range during the day. However, a threshold of 70 mg/dL seems to be safe in the duration of the physical exercise. PLGM system in adolescents with type 1 diabetes was effective to prevent hypoglycemia during and after exercise, irrespective of the PLGM thresholds used.
Journal Article
Effects of general health checks differ under two different analyses perspectives—the Inter99 randomized study
[...]participants in the IG will have better socioeconomic position and health than participants in the SCG. ECG (n = 47,987) HR 95% CI HR 95% CI Control group 1 (Ref.) 1 (Ref.) Intervention group 0.63 0.51, 0.78 0.99 0.91, 1.09 P-valueb <0.001 Table 1 Hazard ratio (HR) of death in analyses of participants only and intention-to-treat (ITT) analysesa Abbreviations: IG, intervention group; SCG, sample of control group; ECG, entire control group; CI, confidence interval.
Journal Article