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Trials Jul 2024Combination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples' sexual... (Randomized Controlled Trial)
Randomized Controlled Trial
A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa.
BACKGROUND
Combination prevention interventions, when integrated with community-based support, have been shown to be particularly beneficial to adolescent and young peoples' sexual and reproductive health. Between 2020 and 2022, the Africa Health Research Institute in rural South Africa conducted a 2 × 2 randomised factorial trial among young people aged 16-29 years old (Isisekelo Sempilo) to evaluate whether integrated HIV and sexual and reproductive health (HIV/SRH) with or without peer support will optimise delivery of HIV prevention and care. Using mixed methods, we conducted a process evaluation to provide insights to and describe the implementation of a community-based peer-led HIV care and prevention intervention targeting adolescents and young people.
METHODS
The process evaluation was conducted in accordance with the Medical Research Council guidelines using quantitative and qualitative approaches. Self-completed surveys and clinic and programmatic data were used to quantify the uptake of each component of the intervention and to understand intervention fidelity and reach. In-depth individual interviews were used to understand intervention experiences. Baseline sociodemographic factors were summarised for each trial arm, and proportions of participants who accepted and actively engaged in various components of the intervention as well as those who successfully linked to care were calculated. Qualitative data were thematically analysed.
RESULTS
The intervention was feasible and acceptable to young people and intervention implementing teams. In particular, the STI testing and SRH components of the intervention were popular. The main challenges with the peer support implementation were due to fidelity, mainly because of the COVID-19 pandemic. The study found that it was important to incorporate familial support into interventions for young people's sexual health. Moreover, it was found that psychological and social support was an essential component to combination HIV prevention packages for young people.
CONCLUSION
The results demonstrated that peer-led community-based care that integrates SRH services with HIV is a versatile model to decentralise health and social care. The family could be a platform to target restrictive gender and sexual norms, by challenging not only attitudes and behaviours related to gender among young people but also the gendered structures that surround them.
Topics: Humans; Adolescent; South Africa; Young Adult; HIV Infections; Male; Female; Peer Group; Adult; Sexual Health; Reproductive Health; Rural Population; Delivery of Health Care, Integrated; Reproductive Health Services; Social Support; Process Assessment, Health Care
PubMed: 38961492
DOI: 10.1186/s13063-024-08279-3 -
The International Journal of Behavioral... Jul 2024Fundamental motor skills (FMS) and physical fitness (FIT) play important roles in child development and provide a foundation for lifelong participation in physical... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of a staff-led multicomponent physical activity intervention on preschooler's fundamental motor skills and physical fitness: The ACTNOW cluster-randomized controlled trial.
BACKGROUND
Fundamental motor skills (FMS) and physical fitness (FIT) play important roles in child development and provide a foundation for lifelong participation in physical activity (PA). Unfortunately, many children have suboptimal levels of PA, FMS, and FIT. The Active Learning Norwegian Preschool(er)s (ACTNOW) study investigated the effects of a staff-led PA intervention on FMS, FIT, and PA in 3-5-year-old children.
METHODS
Preschools in Western Norway having ≥ six 3-4-year-old children were invited (n = 56). Of these, 46 agreed to participate and were cluster-randomized into an intervention (n = 23 preschools [381 children, 3.8 yrs., 55% boys]) or a control group (n = 23 [438, 3.7 yrs., 52% boys]). Intervention preschools participated in an 18-month PA intervention involving a 7-month staff professional development between 2019 and 2022, amounting to 50 h, including face-to-face seminars, webinars, and digital lectures. Primary outcomes in ACTNOW were cognition variables, whereas this study investigated effects on secondary outcomes. FMS was measured through 9 items covering locomotor, object control, and balance skills. FIT was assessed as motor fitness (4 × 10 shuttle-run test) and upper and lower muscular strength (handgrip and standing long jump). PA was measured with accelerometers (ActiGraph GT3X +). All measures took place at baseline, 7-, and 18-month follow-up. Effects were analysed using a repeated measures linear mixed model with child and preschool as random effects and with adjustment for baseline scores.
RESULTS
Participants in the intervention preschools showed positive, significant effects for object control skills at 7 months (standardized effect size (ES) = 0.17) and locomotor skills at 18 months (ES = 0.21) relative to controls. A negative effect was found for handgrip strength (ES = -0.16) at 7 months. No effects were found for balance skills, standing long jump, or motor fitness. During preschool hours, sedentary time decreased (ES = -0.18), and light (ES = 0.14) and moderate-to-vigorous PA (ES = 0.16) increased at 7 months, whereas light PA decreased at 18 months (ES = -0.15), for intervention vs control. No effects were found for other intensities or full day PA.
CONCLUSIONS
The ACTNOW intervention improved some FMS outcomes and increased PA short-term. Further research is needed to investigate how to improve effectiveness of staff-led PA interventions and achieve sustainable improvements in children's PA, FMS, and FIT.
TRIAL REGISTRATION
Clinicaltrials.gov, identifier NCT04048967 , registered August 7, 2019.
FUNDING
ACTNOW was supported by the Research Council of Norway (grant number 287903), the County Governor of Sogn og Fjordane, the Sparebanken Sogn og Fjordane Foundation, and the Western Norway University of Applied Sciences.
Topics: Humans; Male; Female; Motor Skills; Norway; Physical Fitness; Exercise; Child, Preschool; Health Promotion; Child Development; Staff Development; Hand Strength
PubMed: 38961489
DOI: 10.1186/s12966-024-01616-4 -
Trials Jul 2024Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass...
Effectiveness of a mobile application for independent computerized cognitive training in patients with mild cognitive impairment: study protocol for the NeNaE Study, a randomized controlled trial.
BACKGROUND
Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention ("NeuroNation MED") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability.
METHODS
This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT ("NeuroNation MED") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed.
DISCUSSION
This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision.
TRIAL REGISTRATION
German Clinical Trials Register DRKS00025133. Registered on November 5, 2021.
Topics: Humans; Cognitive Dysfunction; Single-Blind Method; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Mobile Applications; Cognition; Treatment Outcome; Therapy, Computer-Assisted; Time Factors; Quality of Life; Germany; Aged; Male; Female; Cognitive Behavioral Therapy; Cognitive Training
PubMed: 38961472
DOI: 10.1186/s13063-024-08277-5 -
Trials Jul 2024One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the...
BACKGROUND
One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation.
METHODS
"POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. Patients either receive automated ventilation by means of INTELLiVENT-ASV or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.
DISCUSSION
POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.
TRIAL REGISTRATION
Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.
Topics: Humans; Cardiac Surgical Procedures; Multicenter Studies as Topic; Respiration, Artificial; Treatment Outcome; Postoperative Care; Time Factors; Randomized Controlled Trials as Topic; Equivalence Trials as Topic; Intensive Care Units
PubMed: 38961468
DOI: 10.1186/s13063-024-08296-2 -
Trials Jul 2024Neck pain is a prevalent global musculoskeletal issue, significantly contributing to the loss of years of healthy life due to disability. Chronic nonspecific neck pain...
BACKGROUND
Neck pain is a prevalent global musculoskeletal issue, significantly contributing to the loss of years of healthy life due to disability. Chronic nonspecific neck pain (CNNP) involves diverse symptoms impacting mobility and quality of life. While therapeutic exercises demonstrate efficacy, the role of photobiomodulation therapy (PBMT) remains uncertain. This study aims to assess the additional effects of PBMT within a multimodal therapeutic intervention for CNNP.
METHODS
A randomized, two-arm, controlled, blind clinical trial follows CONSORT and SPIRIT guidelines. Participants diagnosed with CNNP will receive a stand-alone multimodal therapeutic intervention or the same program with additional PBMT. The primary outcomes will be assessed by the functional disability identified through applying the NDI (Neck Disability Index). Secondary outcomes will be pain intensity during rest and active neck movement, catastrophizing and kinesiophobia, functionality, and disability assessed at baseline, after 8 weeks, and at a 4-week follow-up. Both groups receive pain education before personalized interventions, including resistance exercises, neuromuscular activities, mobility, and body balance. The PBMT group undergoes low-level light therapy. Intention-to-treat analysis, using linear mixed models, employs data presented as mean, standard deviation, and differences with a 95% confidence interval. Non-normally distributed variables transform. Statistical significance is set at 5%.
DISCUSSION
This study addresses a critical gap in understanding the combined effects of PBMT and therapeutic exercises for CNNP. The findings aim to guide clinicians, researchers, and CNNP sufferers through rigorous methodology and diverse outcome assessments, offering valuable insights into evidence-based practices for CNNP management. Data confidentiality is maintained throughout, ensuring participant privacy during statistical analysis.
TRIAL REGISTRATION
Effects of adding photobiomodulation to a specific therapeutic exercise program for the treatment of individuals with chronic nonspecific neck pain, registration number: NCT05400473, on 2022-05-27.
Topics: Humans; Neck Pain; Low-Level Light Therapy; Chronic Pain; Randomized Controlled Trials as Topic; Combined Modality Therapy; Treatment Outcome; Pain Measurement; Disability Evaluation; Adult; Female; Male; Middle Aged; Exercise Therapy; Time Factors; Quality of Life
PubMed: 38961460
DOI: 10.1186/s13063-024-08289-1 -
BMC Musculoskeletal Disorders Jul 2024Crowe IV developmental dysplasia of the hip (DDH) is a catastrophic hip disease. Moreover, obtaining ideal clinical efficacy in conventional total hip arthroplasty (THA)...
PURPOSE
Crowe IV developmental dysplasia of the hip (DDH) is a catastrophic hip disease. Moreover, obtaining ideal clinical efficacy in conventional total hip arthroplasty (THA) is often difficult. In this study, we aimed to assess the mid-term clinical results of THA with porous tantalum trabecular metal (TM) pads for acetabular reconstruction in the treatment of Crowe IV DDH.
METHODS
A cohort of 28 patients (32 hips) diagnosed with Crowe type IV DDH who underwent acetabular reconstruction during THA using TM pads with scheduled follow-up between 2011 and 2018, were included in this study. Eight cases were men and 24 were women, with a mean age of 48.4 years (range, 36-72 years) and a mean follow-up was 74.3 months (range, 42-132 months). All patients underwent acetabular reconstruction using TM pads and total hip replacement with subtrochanteric osteotomy.
RESULTS
At the final follow-up, 28 hips (87.5%) demonstrated mild or no postoperative limping. The Harris Hip Score improved from 58.4 ± 10.6 preoperatively to 85.6 ± 8.9. The mean pain, stiffness, and function scores on the Western Ontario and McMaster University Osteoarthritis index were 86.5 ± 10.2, 87.3 ± 12.4 and 85.4 ± 11.6 respectively. The mean score of patient satisfaction was 90.4 ± 7.6. Additionally, the SF-12 physical summary score was 41.8 ± 5.6 and the SF-12 mental summary score was 51.6 ± 5.4. TM construct survivorship due to all-cause failure was 90.6% at 5 years with 3 hips at risk, 87.5% at 10 years with 4 hips at risk. The survivorship due to failure from aseptic loosening was 96.9% at 5 years with 1hips at risk and 93.75% at 10 years with 2 hips at risk.
CONCLUSION
This study demonstrated satisfactory mid-term clinical and radiological results with the application of TM pads for acetabular reconstruction combined with THA in patients with Crowe IV DDH.
TRIAL REGISTRATION NUMBER
ChiCTR1800014526, Date: 18/01/2018.
Topics: Humans; Arthroplasty, Replacement, Hip; Middle Aged; Female; Male; Tantalum; Aged; Adult; Follow-Up Studies; Developmental Dysplasia of the Hip; Hip Prosthesis; Treatment Outcome; Acetabulum; Prosthesis Design; Retrospective Studies; Porosity
PubMed: 38961446
DOI: 10.1186/s12891-024-07598-5 -
Alzheimer's Research & Therapy Jul 2024Increasing evidence supports the use of plasma biomarkers of amyloid, tau, neurodegeneration, and neuroinflammation for diagnosis of dementia. However, their performance...
BACKGROUND
Increasing evidence supports the use of plasma biomarkers of amyloid, tau, neurodegeneration, and neuroinflammation for diagnosis of dementia. However, their performance for positive and differential diagnosis of dementia with Lewy bodies (DLB) in clinical settings is still uncertain.
METHODS
We conducted a retrospective biomarker study in two tertiary memory centers, Paris Lariboisière and CM2RR Strasbourg, France, enrolling patients with DLB (n = 104), Alzheimer's disease (AD, n = 76), and neurological controls (NC, n = 27). Measured biomarkers included plasma Aβ40/Aβ42 ratio, p-tau181, NfL, and GFAP using SIMOA and plasma YKL-40 and sTREM2 using ELISA. DLB patients with available CSF analysis (n = 90) were stratified according to their CSF Aβ profile.
RESULTS
DLB patients displayed modified plasma Aβ ratio, p-tau181, and GFAP levels compared with NC and modified plasma Aβ ratio, p-tau181, GFAP, NfL, and sTREM2 levels compared with AD patients. Plasma p-tau181 best differentiated DLB from AD patients (ROC analysis, area under the curve [AUC] = 0.80) and NC (AUC = 0.78), and combining biomarkers did not improve diagnosis performance. Plasma p-tau181 was the best standalone biomarker to differentiate amyloid-positive from amyloid-negative DLB cases (AUC = 0.75) and was associated with cognitive status in the DLB group. Combining plasma Aβ ratio, p-tau181 and NfL increased performance to identify amyloid copathology (AUC = 0.79). Principal component analysis identified different segregation patterns of biomarkers in the DLB and AD groups.
CONCLUSIONS
Amyloid, tau, neurodegeneration and neuroinflammation plasma biomarkers are modified in DLB, albeit with moderate diagnosis performance. Plasma p-tau181 can contribute to identify Aβ copathology in DLB.
Topics: Humans; Lewy Body Disease; tau Proteins; Female; Biomarkers; Male; Aged; Amyloid beta-Peptides; Retrospective Studies; Alzheimer Disease; Middle Aged; Aged, 80 and over; Axons; Neuroinflammatory Diseases; Chitinase-3-Like Protein 1; Glial Fibrillary Acidic Protein; Neurofilament Proteins; Peptide Fragments; Receptors, Immunologic; Diagnosis, Differential; Membrane Glycoproteins
PubMed: 38961441
DOI: 10.1186/s13195-024-01502-y -
Trials Jul 2024The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) remains unclear in the immuno-oncology (IO) era. The results of two...
The role of cytoreductive nephrectomy in metastatic renal cell carcinoma in immune-oncology era (SEVURO-CN): study protocol for a multi-center, prospective, randomized trial.
BACKGROUND
The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) remains unclear in the immuno-oncology (IO) era. The results of two randomized trials, CARMENA and SURTIME, questioned the role and timing of CN. However, despite the latest advances in the systemic treatment of mRCC, previous trials have only used targeted therapy, and no studies have fully investigated the role of CN in immune checkpoint inhibitor (CPI) settings, and there is an urgent need for future studies to better define the role and timing of CN.
METHODS
This study is an open-label, multi-center, parallel, prospective, randomized, interventional clinical study to evaluate the efficacy of CN in combination with CPIs in mRCC patients with International mRCC Database Consortium (IMDC) intermediate- and poor-risk. Synchronous mRCC patients with ≤ 3 IMDC risk features will be randomly allocated to three groups (1, upfront CN; 2, deferred CN; and 3, systemic therapy [ST] only). For ST, the nivolumab plus ipilimumab combination regimen, one of the standard regimens for intermediate- and poor-risk mRCC, is chosen. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, objective response rate, number of participants with treatment-related adverse events, and number of participants with surgical morbidity. We will analyze the genetic mutation profiles of the tumor tissue, circulating tumor DNA, urine tumor DNA, and tumor-infiltrating lymphocytes. The gut and urine microbial communities will be analyzed. The study will begin in 2022 and will enroll 55 patients.
DISCUSSION
This study is one of the few prospective randomized trials to evaluate the benefit of CN in the treatment of synchronous mRCC in the IO era. The SEVURO-CN trial will help identify the role and timing of CN, thereby rediscovering the value of CN.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT05753839. Registered on 3 March 2023.
Topics: Humans; Carcinoma, Renal Cell; Kidney Neoplasms; Nephrectomy; Prospective Studies; Cytoreduction Surgical Procedures; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Nivolumab; Immune Checkpoint Inhibitors; Ipilimumab; Treatment Outcome; Antineoplastic Combined Chemotherapy Protocols; Time Factors; Female; Adult
PubMed: 38961439
DOI: 10.1186/s13063-024-08234-2 -
Trials Jul 2024Women with a history of gestational diabetes mellitus (GDM) are 12-fold more likely to develop type 2 diabetes (T2D) 4-6 years after delivery than women without GDM....
A holistic lifestyle mobile health intervention for the prevention of type 2 diabetes and common mental disorders in Asian women with a history of gestational diabetes: a randomised control trial with 3-year follow-up protocol.
BACKGROUND
Women with a history of gestational diabetes mellitus (GDM) are 12-fold more likely to develop type 2 diabetes (T2D) 4-6 years after delivery than women without GDM. Similarly, GDM is associated with the development of common mental disorders (CMDs) (e.g. anxiety and depression). Evidence shows that holistic lifestyle interventions focusing on physical activity (PA), dietary intake, sleep, and mental well-being strategies can prevent T2D and CMDs. This study aims to assess the effectiveness of a holistic lifestyle mobile health intervention (mHealth) with post-GDM women in preventing T2D and CMDs in a community setting in Singapore.
METHODS
The study consists of a 1-year randomised controlled trial (RCT) with a 3-year follow-up period. Post-GDM women with no current diabetes diagnosis and not planning to become pregnant will be eligible for the study. In addition, participants will complete mental well-being questionnaires (e.g. depression, anxiety, sleep) and their child's socio-emotional and cognitive development. The participants will be randomised to either Group 1 (Intervention) or Group 2 (comparison). The intervention group will receive the "LVL UP App", a smartphone-based, conversational agent-delivered holistic lifestyle intervention focused on three pillars: Move More (PA), Eat Well (Diet), and Stress Less (mental wellbeing). The intervention consists of health literacy and psychoeducational coaching sessions, daily "Life Hacks" (healthy activity suggestions), slow-paced breathing exercises, a step tracker (including brisk steps), a low-burden food diary, and a journaling tool. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the "HAPPY App", a mHealth app which provides health promotion information about PA, diet, sleep, and mental wellbeing, as well as display body mass index, blood pressure, and results from the oral glucose tolerance tests. Short-term aggregate effects will be assessed at 26/27 weeks (midpoint) and a 1-year visit, followed by a 2, 3, and 4-year follow-up period.
DISCUSSION
High rates of progression of T2D and CMDs in women with post-GDM suggest an urgent need to promote a healthy lifestyle, including diet, PA, sleep, and mental well-being. Preventive interventions through a holistic, healthy lifestyle may be the solution, considering the inextricable relationship between physical and psychological health. We expect that holistic lifestyle mHealth may effectively support behavioural changes among women with a history of GDM to prevent T2D and CMDs.
TRIAL STATUS
The protocol study was approved by the National Healthcare Group in Singapore, Domain Specific Review Board (DSRB) [2023/00178]; June 2023. Recruitment began on October 18, 2023.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05949957. The first submission date is June 08, 2023.
Topics: Humans; Female; Diabetes Mellitus, Type 2; Diabetes, Gestational; Pregnancy; Telemedicine; Singapore; Randomized Controlled Trials as Topic; Exercise; Holistic Health; Mental Health; Mental Disorders; Follow-Up Studies; Time Factors; Adult; Life Style; Asian People; Healthy Lifestyle; Sleep
PubMed: 38961430
DOI: 10.1186/s13063-024-08247-x -
Alzheimer's Research & Therapy Jul 2024Multimodal lifestyle interventions can benefit overall health, including cognition, in populations at-risk for dementia. However, little is known about the effect of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Multimodal lifestyle interventions can benefit overall health, including cognition, in populations at-risk for dementia. However, little is known about the effect of lifestyle interventions in patients with prodromal Alzheimer's disease (AD). Even less is known about dietary intake and adherence to dietary recommendations within this population making it difficult to design tailored interventions for them.
METHOD
A 6-month MIND-AD pilot randomized controlled trial (RCT) was conducted among 93 participants with prodromal AD in Sweden, Finland, Germany, and France. Three arms were included in the RCT: 1) multimodal lifestyle intervention (nutritional guidance, exercise, cognitive training, vascular/metabolic risk management, and social stimulation); 2) multimodal lifestyle intervention + medical food product; and 3) regular health advice (control group). Adherence to dietary advice was assessed with a brief food intake questionnaire by using the Healthy Diet Index (HDI) and Mediterranean Diet Adherence Screener (MEDAS). The intake of macro- and micronutrients were analyzed on a subsample using 3-day food records.
RESULTS
The dietary quality in the intervention groups, pooled together, improved compared to that of the control group at the end of the study, as measured with by HDI (p = 0.026) and MEDAS (p = 0.008). The lifestyle-only group improved significantly more in MEDAS (p = 0.046) and almost significantly in HDI (p = 0.052) compared to the control group, while the lifestyle + medical food group improved in both HDI (p = 0.042) and MEDAS (p = 0.007) during the study. There were no changes in macro- or micronutrient intake for the intervention groups at follow-up; however, the intakes in the control group declined in several vitamins and minerals when adjusted for energy intake.
CONCLUSION
These results suggest that dietary intervention as part of multimodal lifestyle interventions is feasible and results in improved dietary quality in a population with prodromal AD. Nutrient intakes remained unchanged in the intervention groups while the control group showed a decreasing nutrient density.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03249688, 2017-07-08.
Topics: Humans; Alzheimer Disease; Male; Female; Aged; Prodromal Symptoms; Pilot Projects; Life Style; Diet, Mediterranean; Exercise; Diet; Combined Modality Therapy; Middle Aged; Diet, Healthy
PubMed: 38961421
DOI: 10.1186/s13195-024-01522-8