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N/A N=40 Randomized Double-blind Supportive Care

Childhood Risk Reduction Program in Hispanics

Breast Feeding, Exclusive

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Exclusive Breastfeeding (EBF) — 9; 4; 11; 13 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Early Childhood Obesity Risk-Reduction Program in Hispanics (Behavioral)
Age
Pediatric, Adult, Older Adult
Sex
Female
Sponsor
Ana Maria Linares
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Exclusive Breastfeeding (EBF)
7; 1; 2; 6; 5; 8
PRIMARY
Exclusive Breastfeeding (EBF)
7; 1; 2; 6; 5; 8
PRIMARY
Exclusive Breastfeeding (EBF)
7; 1; 2; 6; 5; 8
SECONDARY
Intention to Breastfeed
13.0; 10.3; 14.37; 10.33
SECONDARY
Social Support
120.76; 121.67
SECONDARY
Knowledge of Breastfeeding
20.1; 18.8; 21.75; 19.0
SECONDARY
Breastfeeding Self-Efficacy
60.06; 62.28; 65.0; 64; 66; 61.29

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03903146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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