scholarly journals Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e035720
Author(s):  
Margaret E Wright ◽  
Emerson Delacroix ◽  
Kendrin R Sonneville ◽  
Shannon Considine ◽  
Tim Proctor ◽  
...  
Keyword(s):  
Primary Care ◽  
Motivational Interviewing ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Overweight And Obesity ◽  
Research Network ◽  
Care Practices ◽  
Child Bmi

IntroductionPrimary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI.Methods and analysisThis cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3– 11 years old with BMI >the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child’s Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes.Ethics and disseminationInstitutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels.Trial registration numberNCT03177148; Pre-results.

scholarly journals A Pilot Randomized Controlled Trial of a Telenutrition Weight Loss Intervention in Middle-Aged and Older Men with Multiple Risk Factors for Cardiovascular Disease

Nutrients ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. 229 ◽  
Author(s):  
Melissa Ventura Marra ◽  
Christa Lilly ◽  
Kelly Nelson ◽  
Dominick Woofter ◽  
James Malone
Keyword(s):  
Primary Care ◽  
Weight Loss ◽  
Controlled Trial ◽  
A Priori ◽  
Intervention Group ◽  
Caloric Intake ◽  
Overweight And Obesity ◽  
Retention Rates ◽  
Weight Loss Intervention ◽  
Dietary Counseling

Overweight and obesity threaten the health, functionality and quality of life of 77.2% men in West Virginia. The purpose of this study was to evaluate the feasibility and effectiveness of a 12-week primary care referred telenutrition weight loss intervention. Fifty-nine 40–70-year-old men with obesity were randomized to either the intervention group (n = 29) or an enhanced usual care (EUC) (n = 30) group. Participants from both groups were prescribed a moderate energy restricted diet (500–750 kcal/day below energy requirements) and provided diet-related educational materials; but, only those in the intervention group received weekly support from a registered dietitian nutritionist via telephone and videoconferencing. Both groups significantly reduced body weight, waist circumference, percent body fat and caloric intake and improved diet quality from baseline (p < 0.0001). Groups did not differ after controlling for time (all p > 0.30) and none of the group by time interactions were statistically significant. At week 12, a greater proportion of participants from the intervention group than the EUC group lost at least 5% of their baseline weight, (70.4% vs. 41.4%, p = 0.035). Retention rates and participant-reported adherence and satisfaction rates were ≥80% in the telenutrition group, thereby meeting the a priori criterion for feasibility of a larger trial. Primary care referred telenutrition interventions have the potential to improve access to dietary counseling for obesity treatment in health disparate populations. A larger longer-term trial is warranted.

Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial

2018 ◽  
Vol 75 (10) ◽  
pp. 703-708 ◽  
Author(s):  
Simon Øverland ◽  
Astrid Louise Grasdal ◽  
Silje Endresen Reme
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Work Participation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundThere is moderate quality evidence that integrating work-directed interventions and components from psychological therapies reduces sickness absence in the medium term. We aimed to extend this evidence by examining objectively ascertained income and work participation status up to 4 years after an intervention to improve outcomes among people who struggle with work from common mental disorder.MethodsThe intervention combined components from cognitive behavioural therapy with principles from supported employment, and compared its efficacy with usual care. Outcomes were derived from registry data with no attrition, in a pragmatic multisite randomised controlled trial (N=1193).ResultsThe intervention group had higher income, higher work participation and more months without receiving benefits over the 10-month to 46-month long-term follow-up period after end of treatment, but differences were not statistically significant. For the group on long-term benefits at inclusion, effect sizes were larger and statistically significant.ConclusionThere were no statistically significant differences between the two groups in the primary outcome in the total population. In a secondary analysis for the subgroup most at risk of permanent work exclusion, long-term outcomes were favourable in the intervention group compared with usual care. The results support integrated work and health services for people on the severe end of work participation challenges.Trial registration numberNCT01146730.

scholarly journals Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m3208
Author(s):  
Steven B Uittenbogaart ◽  
Nicole Verbiest-van Gurp ◽  
Wim A M Lucassen ◽  
Bjorn Winkens ◽  
Mark Nielen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Primary Care ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Care Group ◽  
Opportunistic Screening ◽  
Cluster Randomised ◽  
Care Practices ◽  
Randomised Controlled

AbstractObjectiveTo investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.DesignCluster randomised controlled trial.Setting47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.ParticipantsIn each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.InterventionsOpportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.Main outcome measuresDifference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.ResultsFollow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.ConclusionsOpportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.Trial registrationNetherlands Trial Register No NL4776 (old NTR4914).

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

scholarly journals 0489 Initial Results from the Hypertension with Unsatisfactory Sleep Health (HUSH) Clinical Trial for Primary Care Patients with Insomnia and Comorbid Hypertension (INS-HTN)

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A187-A188
Author(s):  
D J Buysse ◽  
L M Ritterband ◽  
J G Yabes ◽  
B L Rollman ◽  
P J Strollo ◽  
...  
Keyword(s):  
Primary Care ◽  
Sleep Disturbance ◽  
Intervention Group ◽  
Self Report ◽  
Apnea Hypopnea Index ◽  
Dissemination And Implementation ◽  
Patient Reported ◽  
Primary Care Patients ◽  
Care Practices ◽  
Primary Care Practices

Abstract Introduction Insomnia is commonly comorbid with, and may contribute to, hypertension. Cognitive-behavioral treatments improve insomnia, but their effects on hypertension are uncertain, and they are often unavailable in primary care practices, where most INS-HTN patients are treated. We evaluated the efficacy of Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi) compared to enhanced usual care (EUC) on insomnia and home blood pressure (HBP) in primary care patients with INS-HTN. Methods Patients were recruited via electronic health records from 67 primary care practices and randomized 2:2:1 to BBTI delivered via telephone/videoconferencing; SHUTi, an automated, web-based CBT-I program; or EUC including a patient education video. Assessments included self-report questionnaires, home sleep apnea testing, and one week of sleep diary and HBP, measured at Baseline and 9 weeks/ 6 months post-treatment. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. Linear mixed models were fitted for continuous variables on the intent-to-treat sample (n=548), adjusting for age and sex. Chi-square tests were used for proportions. Results Patients were 61.8±11.3 years old, 67.2% female, and 55.9% were taking hypnotics. Insomnia Severity Index (ISI) was 15.4±4.4, Apnea-Hypopnea Index 9.8±11.4, and HBP 130±14/81±9. BBTI and SHUTi were significantly better than EUC (p≤.002) at 9 weeks and 6 months on PROMIS Sleep Disturbance and Sleep-Related Impairment scales, ISI, and diary sleep efficiency, but had inconsistent effects on PROMIS depression and anxiety scales (p=0.001-0.9). Greater proportions of BBTI and SHUTi vs. EUC-treated patients had 9-week and 6-month ISI scores &lt;8 (p=.01, p=.04) and ISI changes scores ≥7 (p=.002, p=.003). HBP did not significantly differ by intervention group. Conclusion BBTI and SHUTi improved insomnia, but did not reduce HBP in patients with INS-HTN. These interventions appear suitable for dissemination and implementation in primary care, but may have limited effects on comorbid symptoms and conditions. Support NHLBI UH2/UH3 HL125103

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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