NCT03903146: ECOR-H

Childhood Risk Reduction Program in Hispanics

Completed NA Results posted Last updated 14 January 2025

What this trial tests

NA trial testing Early Childhood Obesity Risk-Reduction Program in Hispanics in Breast Feeding, Exclusive in 40 participants. Completed in 31 October 2018.

Timeline

23 March 2016

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Ana Maria Linares
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	40
Start date	23 March 2016
Primary completion	31 October 2018
Estimated completion	31 October 2018

Drugs / interventions tested

• Early Childhood Obesity Risk-Reduction Program in Hispanics

Conditions studied

• Breast Feeding, Exclusive — all drugs for Breast Feeding, Exclusive →

Sponsor

Ana Maria Linares

Who can join

Eligibility, female only, with Breast Feeding, Exclusive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Exclusive Breastfeeding (EBF) Primary · At hospital discharge

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 rec

Group	Value	95% CI
Intervention Group	9
Control Group	4
Intervention Group	11
Control Group	13
Intervention Group	0
Control Group	2

Intention to Breastfeed Secondary · Prenatal: At baseline (around 30 weeks of pregnancy) and after 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 i

Baseline (30 weeks)

Group	Value	95% CI
Intervention Group	13.0	± 6.4
Control Group	10.3	± 5.2

37 weeks

Group	Value	95% CI
Intervention Group	14.37	± 1.92
Control Group	10.33	± 5.3

Social Support Secondary · prenatal at baseline

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.

Group	Value	95% CI
Intervention Group	120.76	± 1.98
Control Group	121.67	± 2.68

Knowledge of Breastfeeding Secondary · Prenatal: At baseline (around 30 weeks of pregnancy) and after 37 weeks of pregnancy.

Breast Feeding (BF) Knowledge was assessed at baseline and again before the birth of the infant using an 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. The range of scores is from 0 to 25, with higher scores indicating a greater knowledge of BF. Kuder-Richardson 20 for this sample was 0.72.

Baseline (30 weeks)

Group	Value	95% CI
Intervention Group	20.1	± 3.1
Control Group	18.8	± 3.9

37 weeks

Group	Value	95% CI
Intervention Group	21.75	± 3.0
Control Group	19.0	± 3.38

Breastfeeding Self-Efficacy Secondary · 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.

BFSE at 1 month after Delivery

Group	Value	95% CI
Intervention Group	60.06	± 2.54
Control Group	62.28	± 1.76

BFSE at 3 months

Group	Value	95% CI
Intervention Group	65.0	± 9.25
Control Group	64	± 4.2

BFSE at 6 months

Group	Value	95% CI
Intervention Group	66	± 2.35
Control Group	61.29	± 1.88

Acculturation Secondary · 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.

Group	Value	95% CI
Intervention Group	13	± 1.9
Control Group	10.3	± 5.2

Exclusive Breastfeeding (EBF) Primary · 3 months

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 rec

EBF

Group	Value	95% CI
Intervention Group	7
Control Group	2

Breastfeeding supplementing with formula

Group	Value	95% CI
Intervention Group	4
Control Group	6

Only formula feeding

Group	Value	95% CI
Intervention Group	6
Control Group	9

Exclusive Breastfeeding (EBF) Primary · 6 months

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 rec

EBF

Group	Value	95% CI
Intervention Group	7
Control Group	1

Breastfeeding supplementing with formula

Group	Value	95% CI
Intervention Group	2
Control Group	6

Only formula feeding

Group	Value	95% CI
Intervention Group	5
Control Group	8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.