Complementary feeding: a Global Network cluster randomized controlled trial

BMC Pediatrics

Study Protocol

Omrana Pasha¹  Robert Goldenberg²  Linda L Wright³  Marion Koso-Thomas³  Antoinette Tshefu⁴  Mark Kindem⁵  Ty Hartwell⁵  Norman Goco⁵  Elizabeth McClure⁵  Abhik Das⁵  Manolo Mazariegos⁶  Elwyn Chomba⁷  Waldemar Carlo⁸  Jamie Westcott⁹  K Michael Hambidge⁹  Nancy F Krebs⁹  Carl Bose^1,10 

[1] Aga Khan University, Karachi, Pakistan;Drexel University College of Medicine, Philadelphia, PA, USA;Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA;Kinshasa School of Public Health, Kinshasa, Congo;RTI International, Research Triangle Park, NC, USA;San Carlos University, Guatemala City, Guatemala;University Teaching Hospital, Lusaka, Zambia;University of Alabama, Birmingham, AL, USA;University of Colorado Denver, Aurora, CO, USA;University of North Carolina, Chapel Hill, NC, USA;

关键词: Complementary Feeding;    Complementary Food;    Data Monitoring Committee;    Assessment Team;    Dietary Diversity Score;   

DOI  :  10.1186/1471-2431-11-4

 received in 2010-10-05, accepted in 2011-01-13,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundInadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.Methods/DesignA cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.DiscussionFindings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.Trial registrationNCT01084109

【 授权许可】

CC BY   
© Krebs et al; licensee BioMed Central Ltd. 2011