Maternal Obesity and Breastfeeding Performance

NCT02756169 | Completed

• 2 other identifiers: SALUD-2014-01-234065SSA.SEDESA:101/010/01/16
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators propose this study in order to answer the following research question: An educational intervention and breastfeeding support at postpartum will increase the frequency and total breastfeeding duration in the intervention group? This is a randomized (with control and intervention groups) study, open and parallel (1: 1 ratio between study groups) with 200 pregnant women in the second or third trimester, according to their body mass index (BMI, kg / m2) with excess weight (BMI\> 29 pre-pregnancy weight) and that will address their pregnancy in the public health services and hospitals belonging to the Health Ministry of 5 districts: Coyoacán, Magdalena Contreras, Tlalpan, Xochimilco and Alvaro Obregón in Mexico City. The intervention group and the control group will have the same characteristics for eligibility. The main phases to develop the study are PHASE 1. INTERVENTION DESIGN PHASE 2. IMPLEMENTATION OF THE INTERVENTION. PHASE 3. FOLLOW-UP The intervention will be offered at 3 times: 1) Educational intervention (a workshop) to pregnant obese women. The workshop will be held by an International Board Certified Lactation Consultant (IBCLC) to promote exclusive breastfeeding and to encourage a better breastfeeding performance in accordance with the WHO recommendations. The workshop will be held at convenient times and will be conducted for groups of 8 to 10 participants; 2) Immediate breastfeeding support at hospital by an IBCLC and; 3) The women will be exposed to early telephonic follow-up during the first week of their children´s lives and each month until six months of life. Then, if the breastfeeding continues, every two months until the first year of their children´s life. At the first month postpartum, investigators will visit participants at home, both the control group and the intervention group, for collecting information on breastfeeding practices, for taking a breast milk sample to estimate its fatty acids content, and a blood sample (serum) to obtain the C-Reactive Protein. Also, the investigators will take anthropometric measurements of the children to evaluate their growth (weight, length, and skinfold thickness). Investigators will ask for breastfeeding practices and diet of the participants through a 24 hours recall. The results of this intervention group will be compared with the control group: pregnant obese women without educational intervention or telephonic follow-up.

Conditions

Breastfeeding

Keywords

Obesity; Breastfeeding; Grow up; Milk composition; Mexico

Outcome Measures

Primary Outcomes (1)

• Predominant breastfeeding prevalence

  Percentage of 1 month old (+- 1 week) infants who consume breastmilk as the principal source of nourishment; this includes expressed human milk from own mother. Predominantly breastfed means that it is possible that the infant had received the day prior to the interview, other source of feeding (water and water-based drinks, fruit juice) ritual fluids or ORS, drops or syrups (vitamins, minerals and medicines), and it excludes the consumption of infant formula.

  Within the first month of the child´s life

Secondary Outcomes (3)

• Exclusive breastfeeding prevalence

  Within the first month of the child´s life

• Total duration of breastfeeding

  During the 12 months of the child´s life

• WHO Child Growth Standards

  At the first month and at the 12 months of infant´s life

Other Outcomes (1)

• Breastfeeding Self-Efficacy Scale-Short Form

  Three times: Twice before delivery (once at baseline and again after the workshop), and a third occasion at the first month postpartum.

Study Arms (2)

Intervention

EXPERIMENTAL

One workshop during pregnancy Support for breastfeeding at immediate postpartum Telephonic support after delivery

Other: Intervention

Control

NO INTERVENTION

Standar procedures of neonatal and pregnancy health care at the clinics or hospitals.

Interventions

Intervention OTHER

Three actions since pregnancy until the first year of life of the baby for helping the women with obesity to increase the probability of a successful breastfeeding.

Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant Women \<18 years old with a BMI \>=28, and women \<18 years old with a BMI \>=27, utilizing their pre-pregnancy weight.
• Pregnant women within the second or early third trimester (week 20 through week 34 of gestation).

You may not qualify if:

• Pregnant women under 15 years old.
• Pregnant women diagnosed with HIV or AIDS, Hepatitis B and C, or the Human T lymphotropic virus. In the presence of these, women have the contraindication to feed their children with breast milk.
• Pregnant women with medical conditions that could interfere with breastfeeding, as severe infections transmitted through breast milk.
• Pregnant women with previous breast surgery (as breast reduction) because the lactiferous ducts end up damaged and may lead to poor or no milk production at all.
• Pregnant women that are taking medications that prevent carrying out breastfeeding.
• Pregnant women with a multiple pregnancy (in case of twins, the first born should be taken for the study).
• Exit criteria:
• Newborns with less than 35 weeks of gestational age.
• Newborns dispatched to the neonatal intensive care unit (NICU) from the first day of life.
• Newborns who present major congenital malformations, severe enough to prevent the breastfeeding.
• Elimination criteria:
• Newborns with hypertrophy (large for gestational age), because they may present hypoglycemia and therefore some should require to remain in fast even after starting oral feeding and especially on the first day of life.
• Newborns that enter to the Intermediate Care Unit for a neonatal or maternal adverse event even if the breastfeeding was already initiated.

Sponsors & Collaborators

• Universidad Iberoamericana A.C., Mexico: lead
• Mexican National Institute of Public Health: collaborator
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Universidad Iberoamericana, A.C.

Mexico City, 01219, Mexico

Location

Related Publications (74)

• Jevitt C, Hernandez I, Groer M. Lactation complicated by overweight and obesity: supporting the mother and newborn. J Midwifery Womens Health. 2007 Nov-Dec;52(6):606-13. doi: 10.1016/j.jmwh.2007.04.006.

  PMID: 17983998 BACKGROUND

• Nommsen-Rivers LA, Chantry CJ, Peerson JM, Cohen RJ, Dewey KG. Delayed onset of lactogenesis among first-time mothers is related to maternal obesity and factors associated with ineffective breastfeeding. Am J Clin Nutr. 2010 Sep;92(3):574-84. doi: 10.3945/ajcn.2010.29192. Epub 2010 Jun 23.

  PMID: 20573792 BACKGROUND

• Oddy WH, Li J, Landsborough L, Kendall GE, Henderson S, Downie J. The association of maternal overweight and obesity with breastfeeding duration. J Pediatr. 2006 Aug;149(2):185-91. doi: 10.1016/j.jpeds.2006.04.005.

  PMID: 16887431 BACKGROUND

• Donath SM, Amir LH. Does maternal obesity adversely affect breastfeeding initiation and duration? J Paediatr Child Health. 2000 Oct;36(5):482-6. doi: 10.1046/j.1440-1754.2000.00562.x.

  PMID: 11036806 BACKGROUND

• Li R, Jewell S, Grummer-Strawn L. Maternal obesity and breast-feeding practices. Am J Clin Nutr. 2003 Apr;77(4):931-6. doi: 10.1093/ajcn/77.4.931.

  PMID: 12663294 BACKGROUND

• Wojcicki JM. Maternal prepregnancy body mass index and initiation and duration of breastfeeding: a review of the literature. J Womens Health (Larchmt). 2011 Mar;20(3):341-7. doi: 10.1089/jwh.2010.2248.

  PMID: 21434834 BACKGROUND

• Hilson JA, Rasmussen KM, Kjolhede CL. Maternal obesity and breast-feeding success in a rural population of white women. Am J Clin Nutr. 1997 Dec;66(6):1371-8. doi: 10.1093/ajcn/66.6.1371.

  PMID: 9394689 BACKGROUND

• León-Cava N, Lutter C, Ross Jay, Martin L. Quantifying the benefits of breastfeeding: a summary of the evidence. 2002; Available at: http://www1.paho.org/English/AD/FCH/BOB-Main.html.

  BACKGROUND

• World Health Organization. Infant and young child feeding. Fact sheet 342. 2013; Available at http://www.who.int/mediacentre/factsheets/fs342/en/index.html. Revised on september of 2013.

  BACKGROUND

• Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.

  PMID: 22946888 BACKGROUND

• Gonzalez de Cosio T, Escobar-Zaragoza L, Gonzalez-Castell LD, Rivera-Dommarco JA. [Infant feeding practices and deterioration of breastfeeding in Mexico]. Salud Publica Mex. 2013;55 Suppl 2:S170-9. Spanish.

  PMID: 24626693 BACKGROUND

• Barquera S, Campos-Nonato I, Hernandez-Barrera L, Pedroza A, Rivera-Dommarco JA. [Prevalence of obesity in Mexican adults 2000-2012]. Salud Publica Mex. 2013;55 Suppl 2:S151-60. Spanish.

  PMID: 24626691 BACKGROUND

• Diet, nutrition, and the prevention of chronic diseases. Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1990;797:1-204. No abstract available.

  PMID: 2124402 BACKGROUND

• Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

  PMID: 11234459 BACKGROUND

• Astrup A, Dyerberg J, Selleck M, Stender S. Nutrition transition and its relationship to the development of obesity and related chronic diseases. Obes Rev. 2008 Mar;9 Suppl 1:48-52. doi: 10.1111/j.1467-789X.2007.00438.x.

  PMID: 18307699 BACKGROUND

• Clark JM, Brancati FL. The challenge of obesity-related chronic diseases. J Gen Intern Med. 2000 Nov;15(11):828-9. doi: 10.1046/j.1525-1497.2000.00923.x. No abstract available.

  PMID: 11119178 BACKGROUND

• Lawrence RA, Lawrence RM. Breastfeeding: A guide for the medical profession- 6th edition, Pensylvania. Elsevier MOSBY; 2005.

  BACKGROUND

• Perez-Escamilla R, Curry L, Minhas D, Taylor L, Bradley E. Scaling up of breastfeeding promotion programs in low- and middle-income countries: the "breastfeeding gear" model. Adv Nutr. 2012 Nov 1;3(6):790-800. doi: 10.3945/an.112.002873.

  PMID: 23153733 BACKGROUND

• Chapman DJ, Morel K, Anderson AK, Damio G, Perez-Escamilla R. Breastfeeding peer counseling: from efficacy through scale-up. J Hum Lact. 2010 Aug;26(3):314-26. doi: 10.1177/0890334410369481.

  PMID: 20715336 BACKGROUND

• Chapman DJ, Morel K, Bermudez-Millan A, Young S, Damio G, Perez-Escamilla R. Breastfeeding education and support trial for overweight and obese women: a randomized trial. Pediatrics. 2013 Jan;131(1):e162-70. doi: 10.1542/peds.2012-0688. Epub 2012 Dec 3.

  PMID: 23209111 BACKGROUND

• Rasmussen KM, Dieterich CM, Zelek ST, Altabet JD, Kjolhede CL. Interventions to increase the duration of breastfeeding in obese mothers: the Bassett Improving Breastfeeding Study. Breastfeed Med. 2011 Apr;6(2):69-75. doi: 10.1089/bfm.2010.0014. Epub 2010 Oct 19.

  PMID: 20958105 BACKGROUND

• World Health Organization. Indicators for assessing infant and young child feeding practices. Part 3: country profiles. Geneva: WHO, 2008.

  BACKGROUND

• Choque, R. Comunicación y educación para la promoción de la salud. FAS. Lima-Perú, 2005

  BACKGROUND

• Organización Mundial para la Salud, Organización Panamericana de la Salud. Manual de comunicación social para programas de promoción de la salud de los adolescentes, 2001.

  BACKGROUND

• US DEPARTMENT OF HEALTH & HUMAN SERVICES. Making health communication programs work. National Cancer Institute, 2001

  BACKGROUND

• Organización Panamericana de la Salud. Herramientas de comunicación para el desarrollo de entornos saludables, 2006.

  BACKGROUND

• Dyson L, McCormick F, Renfrew MJ. Interventions for promoting the initiation of breastfeeding. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001688. doi: 10.1002/14651858.CD001688.pub2.

  PMID: 15846621 BACKGROUND

• Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Breastfeeding support, In: Cochrane Plus Library, 2008 Number 2. Oxford: Update Software Ltd. Available at: http://www.update-software.com. (The Cochrane Library, 2008 Issue 2. Chichester, UK: John Wiley & Sons, Ltd.).

  BACKGROUND

• Bandura, A. Health promotion from the perspective of social cognitive theory. Psychol Health, 1998;13:623-649

  BACKGROUND

• Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.

  PMID: 1955608 BACKGROUND

• Eidman C. Enhancing Breastfeeding Self.Eficacy through Prenatal Education. Master of Arts in Nursing Theses, 2011;1-24.

  BACKGROUND

• Baker JL, Gamborg M, Heitmann BL, Lissner L, Sorensen TI, Rasmussen KM. Breastfeeding reduces postpartum weight retention. Am J Clin Nutr. 2008 Dec;88(6):1543-51. doi: 10.3945/ajcn.2008.26379.

  PMID: 19064514 BACKGROUND

• Dewey KG, Heinig MJ, Nommsen LA. Maternal weight-loss patterns during prolonged lactation. Am J Clin Nutr. 1993 Aug;58(2):162-6. doi: 10.1093/ajcn/58.2.162.

  PMID: 8338042 BACKGROUND

• Gunderson EP, Jacobs DR Jr, Chiang V, Lewis CE, Feng J, Quesenberry CP Jr, Sidney S. Duration of lactation and incidence of the metabolic syndrome in women of reproductive age according to gestational diabetes mellitus status: a 20-Year prospective study in CARDIA (Coronary Artery Risk Development in Young Adults). Diabetes. 2010 Feb;59(2):495-504. doi: 10.2337/db09-1197. Epub 2009 Dec 3.

  PMID: 19959762 BACKGROUND

• Ram KT, Bobby P, Hailpern SM, Lo JC, Schocken M, Skurnick J, Santoro N. Duration of lactation is associated with lower prevalence of the metabolic syndrome in midlife--SWAN, the study of women's health across the nation. Am J Obstet Gynecol. 2008 Mar;198(3):268.e1-6. doi: 10.1016/j.ajog.2007.11.044. Epub 2008 Jan 14.

  PMID: 18191796 BACKGROUND

• Schwarz EB, Brown JS, Creasman JM, Stuebe A, McClure CK, Van Den Eeden SK, Thom D. Lactation and maternal risk of type 2 diabetes: a population-based study. Am J Med. 2010 Sep;123(9):863.e1-6. doi: 10.1016/j.amjmed.2010.03.016.

  PMID: 20800156 BACKGROUND

• Stuebe AM, Rich-Edwards JW, Willett WC, Manson JE, Michels KB. Duration of lactation and incidence of type 2 diabetes. JAMA. 2005 Nov 23;294(20):2601-10. doi: 10.1001/jama.294.20.2601.

  PMID: 16304074 BACKGROUND

• Kjos SL, Henry O, Lee RM, Buchanan TA, Mishell DR Jr. The effect of lactation on glucose and lipid metabolism in women with recent gestational diabetes. Obstet Gynecol. 1993 Sep;82(3):451-5.

  PMID: 8355952 BACKGROUND

• Taylor JS, Kacmar JE, Nothnagle M, Lawrence RA. A systematic review of the literature associating breastfeeding with type 2 diabetes and gestational diabetes. J Am Coll Nutr. 2005 Oct;24(5):320-6. doi: 10.1080/07315724.2005.10719480.

  PMID: 16192255 BACKGROUND

• Klein K, Bancher-Todesca D, Graf T, Garo F, Roth E, Kautzky-Willer A, Worda C. Concentration of free amino acids in human milk of women with gestational diabetes mellitus and healthy women. Breastfeed Med. 2013 Feb;8(1):111-5. doi: 10.1089/bfm.2011.0155. Epub 2012 Apr 27.

  PMID: 22540840 BACKGROUND

• Ali MA, Strandvik B, Palme-Kilander C, Yngve A. Lower polyamine levels in breast milk of obese mothers compared to mothers with normal body weight. J Hum Nutr Diet. 2013 Jul;26 Suppl 1:164-70. doi: 10.1111/jhn.12097. Epub 2013 Apr 30.

  PMID: 23627874 BACKGROUND

• Storck Lindholm E, Strandvik B, Altman D, Moller A, Palme Kilander C. Different fatty acid pattern in breast milk of obese compared to normal-weight mothers. Prostaglandins Leukot Essent Fatty Acids. 2013 Mar;88(3):211-7. doi: 10.1016/j.plefa.2012.11.007. Epub 2012 Dec 27.

  PMID: 23273824 BACKGROUND

• Panagos P, Matthan N, Sen S. Effects of maternal obesity on breastmilk composition and infant growth. FASEB J April 2014 28:247

  BACKGROUND

• Andreas NJ, Hyde MJ, Gale C, Parkinson JR, Jeffries S, Holmes E, Modi N. Effect of maternal body mass index on hormones in breast milk: a systematic review. PLoS One. 2014 Dec 23;9(12):e115043. doi: 10.1371/journal.pone.0115043. eCollection 2014.

  PMID: 25536196 BACKGROUND

• Pedersen L, Lauritzen L, Brasholt M, Buhl T, Bisgaard H. Polyunsaturated fatty acid content of mother's milk is associated with childhood body composition. Pediatr Res. 2012 Dec;72(6):631-6. doi: 10.1038/pr.2012.127. Epub 2012 Sep 24.

  PMID: 23007033 BACKGROUND

• Much D, Brunner S, Vollhardt C, Schmid D, Sedlmeier EM, Bruderl M, Heimberg E, Bartke N, Boehm G, Bader BL, Amann-Gassner U, Hauner H. Breast milk fatty acid profile in relation to infant growth and body composition: results from the INFAT study. Pediatr Res. 2013 Aug;74(2):230-7. doi: 10.1038/pr.2013.82. Epub 2013 May 28.

  PMID: 23715519 BACKGROUND

• Dewey KG, Nommsen-Rivers LA, Heinig MJ, Cohen RJ. Risk factors for suboptimal infant breastfeeding behavior, delayed onset of lactation, and excess neonatal weight loss. Pediatrics. 2003 Sep;112(3 Pt 1):607-19. doi: 10.1542/peds.112.3.607.

  PMID: 12949292 BACKGROUND

• Rasmussen KM, Kjolhede CL. Prepregnant overweight and obesity diminish the prolactin response to suckling in the first week postpartum. Pediatrics. 2004 May;113(5):e465-71. doi: 10.1542/peds.113.5.e465.

  PMID: 15121990 BACKGROUND

• Esposito K, Pontillo A, Di Palo C, Giugliano G, Masella M, Marfella R, Giugliano D. Effect of weight loss and lifestyle changes on vascular inflammatory markers in obese women: a randomized trial. JAMA. 2003 Apr 9;289(14):1799-804. doi: 10.1001/jama.289.14.1799.

  PMID: 12684358 BACKGROUND

• Hennigar S, Velasquez V and Kelleher S. Diet-induced obesity compromises lactation through zinc-mediated ER stress and autophagy, promoting premature involution. FASEB J April 2014; 28:910.4

  BACKGROUND

• Nommsen-Rivers L, Glueck C, Huang B, Wang P, and Dolan L. Lactation sufficiency is predicted by fasting plasma glucose at 1 month postpartum (131.1) FASEB J April 2014;28:131.1

  BACKGROUND

• Smith, L. J. Impact of birthing practices on breastfeeding, 2nd Ed. Sudbury, MA: Jones and Bartlett Publishers. (2010).

  BACKGROUND

• Wagner EA, Chantry CJ, Dewey KG, Nommsen-Rivers LA. Breastfeeding concerns at 3 and 7 days postpartum and feeding status at 2 months. Pediatrics. 2013 Oct;132(4):e865-75. doi: 10.1542/peds.2013-0724. Epub 2013 Sep 23.

  PMID: 24062375 BACKGROUND

• Matias SL, Nommsen-Rivers LA, Creed-Kanashiro H, Dewey KG. Risk factors for early lactation problems among Peruvian primiparous mothers. Matern Child Nutr. 2010 Apr;6(2):120-33. doi: 10.1111/j.1740-8709.2009.00195.x.

  PMID: 20624209 BACKGROUND

• Geddes DT. Inside the lactating breast: the latest anatomy research. J Midwifery Womens Health. 2007 Nov-Dec;52(6):556-63. doi: 10.1016/j.jmwh.2007.05.004.

  PMID: 17983992 BACKGROUND

• Lovelady CA. Is maternal obesity a cause of poor lactation performance. Nutr Rev. 2005 Oct;63(10):352-5. doi: 10.1111/j.1753-4887.2005.tb00113.x.

  PMID: 16295148 BACKGROUND

• Evans A, Marinelli KA, Taylor JS; Academy of Breastfeeding Medicine. ABM clinical protocol #2: Guidelines for hospital discharge of the breastfeeding term newborn and mother: "The going home protocol," revised 2014. Breastfeed Med. 2014 Jan-Feb;9(1):3-8. doi: 10.1089/bfm.2014.9996.

  PMID: 24456024 BACKGROUND

• Anstey EH and Jevitt C. Maternal Obesity and Breastfeeding A Review of the Evidence and Implications for Practice. Clinical Lactation, 2011;2-3:11-16

  BACKGROUND

• Chambers JA, McInnes RJ, Hoddinott P, Alder EM. A systematic review of measures assessing mothers' knowledge, attitudes, confidence and satisfaction towards breastfeeding. Breastfeed Rev. 2007 Nov;15(3):17-25.

  PMID: 18062138 BACKGROUND

• Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. 3rd ed. New York: Wiley, 2003.

  BACKGROUND

• Lohman T. Advances in body composition assessment. Human Kinetics. Champaign IL: Publishers; 1992.

  BACKGROUND

• Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.

  PMID: 23178060 BACKGROUND

• Daly SE, Di Rosso A, Owens RA, Hartmann PE. Degree of breast emptying explains changes in the fat content, but not fatty acid composition, of human milk. Exp Physiol. 1993 Nov;78(6):741-55. doi: 10.1113/expphysiol.1993.sp003722.

  PMID: 8311942 BACKGROUND

• Kent JC, Mitoulas LR, Cregan MD, Geddes DT, Larsson M, Doherty DA, Hartmann PE. Importance of vacuum for breastmilk expression. Breastfeed Med. 2008 Mar;3(1):11-9. doi: 10.1089/bfm.2007.0028.

  PMID: 18333764 BACKGROUND

• Garcia-Lara NR, Escuder-Vieco D, Garcia-Algar O, De la Cruz J, Lora D, Pallas-Alonso C. Effect of freezing time on macronutrients and energy content of breastmilk. Breastfeed Med. 2012 Aug;7(4):295-301. doi: 10.1089/bfm.2011.0079. Epub 2011 Nov 2.

  PMID: 22047109 BACKGROUND

• FOLCH J, LEES M, SLOANE STANLEY GH. A simple method for the isolation and purification of total lipides from animal tissues. J Biol Chem. 1957 May;226(1):497-509. No abstract available.

  PMID: 13428781 BACKGROUND

• Lepage G, Roy CC. Direct transesterification of all classes of lipids in a one-step reaction. J Lipid Res. 1986 Jan;27(1):114-20.

  PMID: 3958609 BACKGROUND

• Ledue TB, Weiner DL, Sipe JD, Poulin SE, Collins MF, Rifai N. Analytical evaluation of particle-enhanced immunonephelometric assays for C-reactive protein, serum amyloid A and mannose-binding protein in human serum. Ann Clin Biochem. 1998 Nov;35 ( Pt 6):745-53. doi: 10.1177/000456329803500607.

  PMID: 9838988 BACKGROUND

• US Department of Health and Human Services. Food and Drug Administration. Review criteria for assessment of C-reactive protein (CRP), high sensitivity C-reactive protein (hsCRP) and cardiac C-reactive protein (cCRP) Assays. Document issued on: September 22, 2005. Available at: NK http://www.fda.gov/cdrh/oivd/guidance/1246.pdf

  BACKGROUND

• Hartman AM, Brown CC, Palmgren J, Pietinen P, Verkasalo M, Myer D, Virtamo J. Variability in nutrient and food intakes among older middle-aged men. Implications for design of epidemiologic and validation studies using food recording. Am J Epidemiol. 1990 Nov;132(5):999-1012. doi: 10.1093/oxfordjournals.aje.a115743.

  PMID: 2239915 BACKGROUND

• Manual de Instrumentos para la Evaluación Dietética. Guatemala: Instituto de Nutrición de Centro América y Panamá, 2006.

  BACKGROUND

• National Institute of Public Health of Mexico. Food Composition Database. Unpublished document. 2013.

  BACKGROUND

• Institute of Medicine. Energy. In: Dietary reference intakes for energy, carbohydrates, fiber, fat, protein and amino acids (macronutrients). Washington, DC: Institute of Medicine, The National Academies Press, 2005:107-264.

  BACKGROUND

• Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.

  PMID: 12768890 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Teresita González de Cosío, PhD.

  Universidad Iberoamericana, A.C.

  STUDY CHAIR

• Sonia L. Hernández Cordero, PhD.

  Universidad Iberoamericana, A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 29, 2016
• Study Start: July 14, 2016
• Primary Completion: February 11, 2018
• Study Completion: February 28, 2018
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)