Maternal Obesity and Breastfeeding Performance

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

Interventions

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.

Sponsors & Collaborators

• Mexican National Institute of Public Health

  collaborator OTHER_GOV

• National Council of Science and Technology, Mexico

  collaborator OTHER

• Universidad Iberoamericana A.C., Mexico

  lead OTHER

Principal Investigators

• Teresita González de Cosío, PhD. · Universidad Iberoamericana, A.C.

• Sonia L. Hernández Cordero, PhD. · Universidad Iberoamericana, A.C.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-14

Primary Completion

2018-02-11

Completion

2018-02-28

Countries

• Mexico

Study Locations