Implementation of the NHLBI Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents: Rationale and study design for Young Hearts, Strong Starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco

ABSTRAK Latar Belakang: Pemenuhan gizi pada masa prakonsepsi merupakan hal yang penting untuk memastikan kehamilan yang sehat, namun banyak wanita di negara-negara berkembang yang belum menyadari pentingnya hal tersebut. Informasi tentang kesiapan gizi prakonsepsi pada wanita usia subur, khususnya di negara berkembang, masih terbatas.Tujuan: Untuk mengetahui kesiapan gizi prakonsepsi pada calon pengantin wanita di IndonesiaMetode: Penelitian ini merupakan bagian dari studi cluster randomized trial untuk meningkatkan status besi ibu hamil di Kabupaten Bantul, Yogyakarta, yang melibatkan 173 calon pengantin wanita. Data antropometri, asupan makan, dan pengetahuan tentang gizi prakonsepsi dikumpulkan oleh enumerator yang terlatih, yaitu mahasiswa di Fakultas Kesehatan, Universitas Alma Ata, dengan melakukan kunjungan ke rumah responden. Data kadar Hemoglobin (Hb) diperoleh melalui kuesioner. Kesiapan gizi prakonsepsi diukur menggunakan 10 indikator, yang meliput: (1) Indeks Massa Tubuh (IMT); (2) Lingkar Lengan Atas (LILA); (3) kadar Hb; (4) asupan energi; (5) asupan protein; (6) asupan kalsium; (7) asupan zat besi; (8) asupan folat; (9) pengetahuan tentang gizi prakonsepsi; dan (10) konsumsi suplemen zat besi dan/atau asam folat. Skor kesiapan akan berkisar antara 0-10.Hasil: Tidak ada satupun responden yang dapat memenuhi seluruh indikator kesiapan gizi prakonsepsi. Sebanyak 26% responden dapat memenuhi 2 indikator, dan median skor-nya adalah 3 (2.0-4.0). Kadar Hb, IMT, dan LILA merupakan 3 indikator terbanyak yang dapat dipenuhi, sementara asupan kalsium, zat besi, dan folat merupakan 3 indikator yang paling sedikit dapat dipenuhi oleh responden.Kesimpulan: Peningkatan kesadaran akan pentingnya mempersiapkan gizi prakonsepsi pada calon ibu merupakan hal yang sangat diperlukan. Program intervensi gizi kedepannya sebaiknya sudah dimulai sejak masa prakonsepsi, bukan hanya fokus pada kehamilan. KATA KUNCI: Indeks Massa Tubuh; asupan makan; prakonsepsi; wanita usia subur ABSTRACTBackground: Proper nutrition during preconception is essential to ensuring a healthy pregnancy, however, women in developing countries may not be aware of its importance. Information is limited regarding nutrition readiness prior to conception among women of reproductive age in these settings.Objectives: To examine nutrition readiness prior to conception among premarital women living in Indonesia.Methods: This study was part of a cluster randomized trial which aimed to improve the iron status of pregnant women in Bantul District, Yogyakarta, Indonesia. A total of 173 premarital women were included in the study. Data were collected on anthropometry, dietary intake, and knowledge about preconception nutrition by trained nutrition students of the University of Alma Ata, and taking place in the participant’s home. Hemoglobin level data were obtained based on answers to a questionnaire. Preconception nutrition readiness for pregnancy was determined based on 10 indicators, including: (1) body mass index (BMI); (2) mid-upper arm circumference (MUAC); (3) hemoglobin (Hb) level; average daily intakes for (4) energy, (5) protein, (6) calcium, (7) iron, and (8) folic acid; (9) level of knowledge about preconception nutrition; and (10) folic acid and/or iron supplement consumption. Preconception nutrition readiness scores ranged from 0-10.Results: No study participants met all 10 indicators for preconception nutrition readiness. One-quarter (26.0%) of participants could only meet 2 indicators, and the median score was 3.0 (2.0-4.0). Hb level, BMI, and MUAC were the 3 indicators met most by participants, while iron, folic acid, and calcium intake were the least met indicators.Conclusion: Raising awareness about preconception nutritional preparation among women of reproductive age is urgent. Future nutrition intervention programs should target the preconception period. KEYWORDS: Body mass index; dietary intake; preconception; women of reproductive age.

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Community-Based Interventions to Promote Blood Pressure Control in a Developing Country: A Cluster Randomized Trial

Yearbook of Cardiology ◽

10.1016/s0145-4145(10)79919-6 ◽

2010 ◽

Vol 2010 ◽

pp. 92-93

Author(s):

W.J. Elliott

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Developing Country ◽

Blood Pressure Control ◽

Cluster Randomized Trial ◽

Pressure Control ◽

Community Based Interventions ◽

Community Based ◽

Cluster Randomized

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Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽

10.1161/hyp.70.suppl_1.p494 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Karen L Margolis ◽

Stephen E Asche ◽

Anna R Bergdall ◽

Steven P Dehmer ◽

Beverly B Green ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Routine Clinical Care ◽

Differential Reduction ◽

Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽

10.1186/s13063-021-05729-0 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Marc-Eric Nadeau ◽

Justine L. Henry ◽

Todd C. Lee ◽

Émilie Bortolussi-Courval ◽

Carole Goodine ◽

...

Keyword(s):

Older Adults ◽

Randomized Trial ◽

Study Design ◽

Long Term Care ◽

Cluster Randomized Trial ◽

Stepped Wedge ◽

Term Care ◽

Medication Reviews ◽

Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

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