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Trial record 1 of 4 for:    Hispanics | Breastfeeding, Exclusive
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Childhood Risk Reduction Program in Hispanics (ECOR-H)

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ClinicalTrials.gov Identifier: NCT03903146
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : September 8, 2021
Information provided by (Responsible Party):
Ana Maria Linares, University of Kentucky

Brief Summary:

Childhood obesity is a serious problem in the United States, as it increases the risk for various cardiometabolic, pulmonary, and psychosocial complications for children, which often continue into adulthood. Examination of disparities in early childhood obesity among ethnic groups shows that Hispanic infants/children have higher rates of overweight and obesity than children/infants of other races/ethnicities. According to the most recent National Health and Nutrition Examination Survey (2014), the prevalence of high weight for recumbent length (≥95th percentile) among infant and toddlers from birth to 2 years was 6.6% in Whites, 8.4% in Blacks, and 9.4% in Hispanics. Furthermore, the percentages of children ages 2 through 5 years who are overweight or obese (Body Mass Index [BMI] ≥ 85th) were 20.9% among non-Hispanic Whites, 21.9% among non-Hispanic Blacks, and 29.8% among Hispanics. These data suggest that ethnic disparities in childhood obesity prevalence have their origins in the earliest stages of life.

Bergmann et al. reported that infants that received early formula artificial feeding by 3 months had significantly higher BMIs and thicker skin fold than exclusively breastfed infants, and from 6 months on, compared with breastfed children, a consistently higher proportion of artificially-fed children exceeded the 90th and 97th percentile of BMI and skin folder thickness reference values. Exclusive breastfeeding (EBF), defined as exclusive infant feeding with breast milk without any additional food or drink, is the feeding option engendering greatest nutrition and health, imparting enhanced glucose management and reductions in early childhood obesity.

Hispanic mothers in the U.S. are more likely to supplement with formula in the first 2 days of life, compared with Black and White U.S. mothers (Hispanic 33%; Black 28%; White 22%). Additionally, a common feeding practice among Hispanic mothers is the early introduction of solids including ethnic food. The introduction of formula or complementary food in breastfed Hispanic infants produces an overfeeding problem that leads to childhood obesity. In a study published by this team of investigators on infant feeding management in Hispanic women living in Kentucky was reported that even when 51% of the group of Hispanic mothers initiated EBF during hospital stay, only 22% continued EBF at 4 months after birth. These trends underscore the critical need for intervention to support EBF in this population.

Objectives: There is great opportunity and immense need to empower vulnerable, at-risk Hispanic mother/infant dyads to prevent and manage childhood obesity by increasing duration and EBF and delaying the introduction of complementary food. The primary aim of this pilot study was to determinate the feasibility and evaluate the clinical impact of a novel, tailored, culturally and linguistically appropriate community-based intervention. The intervention was delivered by Hispanics bilingual/bicultural team of an International Board Certified Lactation Consultant (IBCLC) and a peer counselor (PC) and was tested in terms of its influence on key modifiable factors that are positively associated with increasing breastfeeding duration and exclusivity: (a) mother's breastfeeding intention; (b) breastfeeding self-efficacy; and (c) perceived social support. Specific aims for this study are:

Aim 1: Determine the feasibility of the intervention. This aim is designed to answer the following important research questions:

Q-1: Is the planned recruitment period sufficient to enroll the targeted number of participants? Q-2: What percent of treatment group participants will complete all sessions of the intervention? Q-3: What percent of participants will be retained in the study until the conclusion? Q-4: What factors are associated with intervention adherence and study retention?

Aim 2: Evaluate the clinical impact of the intervention. The following hypotheses will be tested:

Hypothesis #1: Women in the intervention group will have higher intention to breastfeed during the pre-natal period and will perceive greater self-efficacy and social support during postnatal period, compared with the usual care group.

Hypothesis #2: Women in the intervention group will be more likely to initiate EBF during their post-delivery in-hospital stay than those in the usual care group.

Hypothesis #3: Among those who practice EBF during their hospital stay, women in the intervention group will be more likely to continue EBF for six months than women in the usual care group.

Hypothesis #4: Women in the intervention group will have longer time to introduction of complementary food to their infants compared with the usual care group.

Condition or disease Intervention/treatment Phase
Breast Feeding, Exclusive Behavioral: Early Childhood Obesity Risk-Reduction Program in Hispanics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomly assigned to intervention or control groups.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: To decrease the feeling of discomfort if the mother was not breastfeeding her infant, the trained research staff collecting data on infant feeding status at T-4, T-5, and T-6 remain blinded to the participant's group. To assure that the research staff remain blinded a script was created that explained the importance that the participant abstained to share with research staff if she was getting the visit of any other research personnel. The script was consistently read to participants in each encounter.
Primary Purpose: Supportive Care
Official Title: Early Childhood Obesity Risk Reduction Program in Hispanics
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention Group
This group of participants was assigned to receive the intervention by the bicultural/bilingual team of Peer counselor and Lactation Consultant. An intensive support intervention (1 prenatal visit, 1 in-hospital visit, 1 home postpartum visit, and free phone calls) were conducted individually to mothers participating until 6 months after the birth of the infant.
Behavioral: Early Childhood Obesity Risk-Reduction Program in Hispanics

Sessions Prenatal (40 min): Includes a colorful binder with information about breastfeeding. Set her goals and action plan for breastfeeding. Past experiences with breastfeeding. Benefits of adopting a healthy behavior, describe and discuss infant feeding and qualms about mixed feeding, barriers to EBF and self-efficacy.

Prenatal Calls (10 min.): Discuss strategies available to accomplish mother's breastfeeding goals. Answer questions. Follow-up call until delivery.

Hospital visit (30 min.): PC visit mother at the hospital stay to support the participant in her effort to breastfeeding.

Postpartum home-visit (40 min.) IBCLC performs a home visit to assess infant feeding pattern, breastfeeding techniques with hands-on assistance if needed. Provide supplemental breastfeeding devices as needed. Answer all questions.

Postpartum calls (10 min.): PC/IBCLC ask about problems/concerns and answer questions. Repeat phone calls as needed (at least 1 a month).

Other Name: Promoting Exclusive breastfeeding in Hispanic Mothers

No Intervention: Control Group
All participants in this group received traditional prenatal care in the clinic and received the usual educational material (in their proficient language) about breastfeeding during prenatal care provided by the Special Supplemental Nutritional for Women, Infants, and Children (WIC) program implemented in the clinics. Women were also able to receive one breastfeeding consultation during their hospital stay in the birthing center as part of the actual protocol established in the UK Chandler Hospital (Baby-friendly Hospital that includes support of breastfeeding during hospital stay). Women in the usual care group did not have any contact with the study IBCLC/PC.

Primary Outcome Measures :
  1. Exclusive breastfeeding (EBF) [ Time Frame: From birth to 6 months old ]
    Infant Feeding Status was determined at discharge via medical chart review from reports in the infant's chart. Follow-up infant feeding status at each encounter post-discharge, was assessed via mother's report; mothers were asked to choose the practice that most closely resembles how she was feeding her infant with possible options of exclusive breastfeeding, predominant breast milk; mixed feeding; predominant formula milk; and exclusive formula milk. Then, the mother was also asked 'Does your baby receive water, juice or any other juices or solids?' If the mother agreed that the infant is receiving additional food, mothers were asked when they introduced the food to their child and portions given by day.

Secondary Outcome Measures :
  1. Intention to breastfeed [ Time Frame: Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy. ]
    Infant Feeding Intention was assessed at baseline and again before the birth of the infant using the Infant Feeding Intentions Scale, Spanish version (IFI). This scale has 5 items, with response options ranging from 0 = 'Very much disagree' to 4 = 'Very much agree.' The total score is obtained by averaging the first 2 items (which include planning about giving breastfeeding a try and another item that is reverse-coded as it is an endorsement of planning to use formula) and adding the remaining 3 items to this mean. The range of scores is from 0 to 16, with higher scores indicating a stronger intention to EBF for 6 months.

  2. Social support [ Time Frame: prenatal at baseline and postnatal at 1 month post partum ]
    Social support was assessed during the prenatal period using the Spanish version of the Autonomy and Relatedness Inventory (ARI). Each of the 32 items is scored on a 5-point scale, with response options ranging from 1 = 'Not at all like' to 5 = 'Very much like.' To calculate a total score, negative items are reversed, all ratings are summed, and then 32 is subtracted from the sum so that the cumulative score ranges from 0 to 128. Higher scores indicate a more positive assessment of the relationship.

  3. Knowledge of breastfeeding [ Time Frame: Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy. ]
    BF Knowledge was assessed at baseline and again before the birth of the infant using and adapted Spanish version of the BF Knowledge Questionnaire. The questionnaire has 25 items, with response options 1= True, and 0 = False. The total score is obtained by first reversing eight of the items by assigning a value of 1 for each correct answer of 'False' and then adding all the items.

  4. Breastfeeding Self-Efficacy [ Time Frame: Post natal at 1, 3, 6 months postpartum only when woman was breastfeeding. ]
    Breastfeeding Self-Efficacy Scale-Short Version (BSES) was used to measure maternal confidence to breastfeed during postpartum. This instrument consists of 14 items, each with a response set ranging from 1 = 'Not at all confident' to 5= 'Very confident.' The summary score is created by adding the 14 items in the scale, with scores ranging from 14 to 70; higher scores indicated greater self-efficacy for breastfeeding.

Other Outcome Measures:
  1. Acculturation [ Time Frame: At Baseline around 30 weeks of pregnancy ]
    The 7-item short version of the Hispanic Acculturation Scale assessed the likelihood of using Spanish or English in different situations. Responses are rated in a five-point choice: only Spanish; Spanish better than English; both equally; English better than Spanish; and only English. The responses are summed, with the total score ranging from 5 to 35, with higher scores indicating a greater degree of acculturation.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • self-identify as Immigrant Hispanic women;
  • pregnant at or beyond 30 weeks of gestation;
  • intention to at least try to breastfeed;
  • planning to deliver at a local birthing hospital; and
  • planning to remain in Central Kentucky for at least 6 months after the birth of their child.

Exclusion Criteria:

  • prior or current participation in any study to enhance breastfeeding;
  • pregnant with twins;
  • history of breast surgery;
  • contraindication to BF (e.g., HIV-positive status, chronic therapy with medications incompatible with BF, alcohol dependence or other substance abuse); and
  • presumed or known congenital fetus defects.
  Study Documents (Full-Text)

Documents provided by Ana Maria Linares, University of Kentucky:
Publications of Results:
Other Publications:
Centers for Disease Control and Prevention C. Final Formula Supplementation of Breast Milk Rates by Socio-demographic Factors, Among Children Born in 2006. 2012c; http://www.cdc.gov/breastfeeding/data/NIS_data/2006/socio-demographic_formula.htm, 2012.
Marin G, Sabogal F, Marin BV, Otero-Sabogal R, Perez-Stable EJ. Development of a Short Acculturation Scale for Hispanics. Hispanic Journal of Behavioral Sciences. 1987;9 (2 ):183-205

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Responsible Party: Ana Maria Linares, Associate Professor of Nursing, University of Kentucky
ClinicalTrials.gov Identifier: NCT03903146    
Other Study ID Numbers: 16-0164-P2H
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Maria Linares, University of Kentucky:
Exclusive breastfeeding
Hispanic Women