scholarly journals Comments on “A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial”

2019 ◽  
Vol 110 (2) ◽  
pp. 526-527
Author(s):  
David Flood ◽  
Waleska López Canú ◽  
Anita Chary ◽  
Peter Rohloff
Keyword(s):  
Randomized Controlled Trial ◽  
Maternal Nutrition ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Nutrition Supplementation

scholarly journals A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial

2019 ◽  
Vol 109 (2) ◽  
pp. 457-469 ◽  
Author(s):  
K Michael Hambidge ◽  
Jamie E Westcott ◽  
Ana Garcés ◽  
Lester Figueroa ◽  
Shivaprasad S Goudar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gestational Age ◽  
Maternal Nutrition ◽  
Controlled Trial ◽  
First Trimester ◽  
Maternal Body Mass Index ◽  
Low Resource ◽  
Randomized Controlled ◽  
Nutrition Supplementation ◽  
Republic Of The Congo

ABSTRACT Background Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited. Objectives This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3). Methods Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m2) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA). Results A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms. Conclusions In low-resource populations, benefits on fetal growth–related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. This trial was registered at clinicaltrials.gov as NCT01883193.

scholarly journals Preconception maternal nutrition: a multi-site randomized controlled trial

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
K Michael Hambidge ◽  
◽  
Nancy F Krebs ◽  
Jamie E Westcott ◽  
Ana Garces ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Maternal Nutrition ◽  
Controlled Trial ◽  
Randomized Controlled

A Randomized Controlled Trial of Prenatal Nutritional Supplementation

PEDIATRICS ◽  
1980 ◽  
Vol 65 (4) ◽  
pp. 835-836
Author(s):  
Howard N. Jacobson
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intake ◽  
Study Design ◽  
Research Council ◽  
Maternal Nutrition ◽  
Controlled Trial ◽  
National Research Council ◽  
Nutritional Supplement ◽  
Nutritional Supplementation ◽  
Randomized Controlled

This report is the long-awaited presentation of the results of the major study on the use of nutritional supplementation to improve the outcomes of pregnancy. In this study, a nutritional supplement refers to the provision of specified amounts of nutrients in a formula made up as a beverage. The formula would be used to aid in the quantification of the dietary intake of nutrients under study, in this case calories and protein. The expectation was that the supplements would be consumed in addition to the diet normally consumed and that they would not displace foods normally eaten. The study design was initially presented at a workshop on nutritional supplementation and the outcome of pregnancy and sponsored by the Committee on Maternal Nutrition, National Research Council, in November 1971.1

scholarly journals Challenges of Implementing an Individual Randomized Controlled Trial (Women First: Preconception Maternal Nutrition Study) in a Rural Study Site: A Case Study From Pakistan

2019 ◽  
Vol 12 ◽  
pp. 117863881985205
Author(s):  
Sumera Aziz Ali ◽  
Umber Khan ◽  
Farina Abrejo ◽  
Sarah Saleem ◽  
Michael K Hambidge ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rural Areas ◽  
Maternal Nutrition ◽  
Close Contact ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Nutrition Study ◽  
Long Time ◽  
Maternal And Neonatal Outcomes ◽  
Study Participants

Persistent global disparities in maternal and neonatal outcomes associated with poor maternal nutrition provided the genesis of the Women First (WF) study, an individually randomized controlled trial on preconceptional maternal nutrition. This article describes the challenges that arose in implementing this trial related to nutrition or diet of the mother, in District Thatta-Pakistan. During different phases of the study, we encountered problems in identifying the eligible participants, taking consent from couples, randomizing participants in different arms, conducting biweekly follow-up visits on time, ensuring compliance to the intervention, and measuring the primary outcome within the 24 hours of birth. Each challenge was itself an opportunity for the research team to address the same through effective coordination and teamwork. Moreover, with adequate resources and dedicated staff with diverse backgrounds, it was possible to implement the WF study across the widely scattered geographic clusters of District Thatta. In addition, there are some broad strategies that could be applied to other studies such as very close contact either in person or at least by talking to mothers via phones and rapport with the study participants, the study leadership of country coordinator and the field supervisors to build trust between those on front lines and the study leadership. Moreover, continuous monitoring and supervision with frequent training and refreshers were also found to be more important to assure the data quality and to meet the study targets. Community meetings were also found to be very helpful and effective to follow the participants for a long time. Researchers conducting a similar type of studies particularly in rural areas can learn many lessons from such experiences. Thus, the process of implementing the study in one of the rural areas of Pakistan provides an insight into where and how similar individual randomized trials might be deployed.

scholarly journals Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial

2018 ◽  
Vol 48 (2) ◽  
pp. 220-228 ◽  
Author(s):  
Liu-Ying Zhu ◽  
Ruth Chan ◽  
Timothy Kwok ◽  
Kenneth Chik-Chi Cheng ◽  
Amy Ha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Chinese People ◽  
Randomized Controlled ◽  
Nutrition Supplementation ◽  
Older Chinese
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