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Maternal Obesity and Breastfeeding Performance

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ClinicalTrials.gov Identifier: NCT02756169
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Mexican National Institute of Public Health
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Teresita Gonzalez de Cosio Martinez, Universidad Iberoamericana A.C., Mexico

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 life and each month until six months of life. Then, if the breastfeeding continues, each 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 the educational intervention or telephonic follow-up.


Condition or disease Intervention/treatment Phase
Breastfeeding Other: Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of an Immediate-postpartum Support by IBCLC to Women With Obesity, on Breastfeeding Performance: A Randomized Trial.
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : February 11, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Intervention
One workshop during pregnancy Support for breastfeeding at immediate postpartum Telephonic support after delivery
Other: Intervention
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.

No Intervention: Control
Standar procedures of neonatal and pregnancy health care at the clinics or hospitals.



Primary Outcome Measures :
  1. Predominant breastfeeding prevalence [ Time Frame: Within the first month of the child´s life ]
    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.


Secondary Outcome Measures :
  1. Exclusive breastfeeding prevalence [ Time Frame: Within the first month of the child´s life ]
    Exclusively breastfed means that the infant received the day prior to the interview, no other food or drink, not even water, except breast milk (including milk expressed from own mother), but allows the infant to receive ORS, drops and syrups (vitamins, minerals and medicines).

  2. Total duration of breastfeeding [ Time Frame: During the 12 months of the child´s life ]
    The number of months the infants were breastfed; this variable will be evaluated up until the first 12 months of the infant's life.

  3. WHO Child Growth Standards [ Time Frame: At the first month and at the 12 months of infant´s life ]
    Comparison of the infants´s height for age, weight for height, weight for age and skinfolds, as compared to the 2008 WHO standards.


Other Outcome Measures:
  1. Breastfeeding Self-Efficacy Scale-Short Form [ Time Frame: Three times: Twice before delivery (once at baseline and again after the workshop), and a third occasion at the first month postpartum. ]
    Is the strength of the woman's belief in her's own ability to breastfeed her child.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756169


Locations
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Mexico
Universidad Iberoamericana, A.C.
Mexico City, Mexico, 01219
Sponsors and Collaborators
Universidad Iberoamericana A.C., Mexico
Mexican National Institute of Public Health
National Council of Science and Technology, Mexico
Investigators
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Principal Investigator: Teresita González de Cosío, PhD. Universidad Iberoamericana, A.C.

Publications:
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.
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.
Lawrence RA, Lawrence RM. Breastfeeding: A guide for the medical profession- 6th edition, Pensylvania. Elsevier MOSBY; 2005.
World Health Organization. Indicators for assessing infant and young child feeding practices. Part 3: country profiles. Geneva: WHO, 2008.
Choque, R. Comunicación y educación para la promoción de la salud. FAS. Lima-Perú, 2005
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.
US DEPARTMENT OF HEALTH & HUMAN SERVICES. Making health communication programs work. National Cancer Institute, 2001
Organización Panamericana de la Salud. Herramientas de comunicación para el desarrollo de entornos saludables, 2006.
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.).
Bandura, A. Health promotion from the perspective of social cognitive theory. Psychol Health, 1998;13:623-649
Eidman C. Enhancing Breastfeeding Self.Eficacy through Prenatal Education. Master of Arts in Nursing Theses, 2011;1-24.
Panagos P, Matthan N, Sen S. Effects of maternal obesity on breastmilk composition and infant growth. FASEB J April 2014 28:247
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
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
Smith, L. J. Impact of birthing practices on breastfeeding, 2nd Ed. Sudbury, MA: Jones and Bartlett Publishers. (2010).
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
Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. 3rd ed. New York: Wiley, 2003.
Lohman T. Advances in body composition assessment. Human Kinetics. Champaign IL: Publishers; 1992.
Folch J, Leas M, Sloane-Stanley GH. A simple method for isolation and purification of total lipids from animal tissues. J Biol Chem 1957;193:265-275.
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
Manual de Instrumentos para la Evaluación Dietética. Guatemala: Instituto de Nutrición de Centro América y Panamá, 2006.
National Institute of Public Health of Mexico. Food Composition Database. Unpublished document. 2013.
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.

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Responsible Party: Teresita Gonzalez de Cosio Martinez, Director of the Health Department, Universidad Iberoamericana A.C., Mexico
ClinicalTrials.gov Identifier: NCT02756169     History of Changes
Other Study ID Numbers: SALUD-2014-01-234065
SSA.SEDESA:101/010/01/16 ( Other Identifier: Ministry of Health of Mexico )
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not plan to make IPD available

Keywords provided by Teresita Gonzalez de Cosio Martinez, Universidad Iberoamericana A.C., Mexico:
Obesity
Breastfeeding
Grow up
Milk composition
Mexico

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms