Maternal Obesity and Breastfeeding Performance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02756169|
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : May 3, 2018
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Single Group Assignment|
|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|
One workshop during pregnancy Support for breastfeeding at immediate postpartum Telephonic support after delivery
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.
- 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.
- 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).
- 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.
- 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.
- 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.
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
|Universidad Iberoamericana, A.C.|
|Mexico City, Mexico, 01219|
|Principal Investigator:||Teresita González de Cosío, PhD.||Universidad Iberoamericana, A.C.|