Breast Feeding, Exclusive Clinical Trial
— ECOR-HOfficial title:
Early Childhood Obesity Risk Reduction Program in Hispanics
Verified date | August 2021 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | October 31, 2018 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ana Maria Linares |
13th Breastfeeding and Feminism International Conference: The Dance of Nurture in a Complex World: How Biology, Gender, and Social Context Shape How We Nourish Our Children. J Hum Lact. 2018 Aug;34(3):600-630. doi: 10.1177/0890334418776646. Epub 2018 Jun — View Citation
Bergmann KE, Bergmann RL, Von Kries R, Böhm O, Richter R, Dudenhausen JW, Wahn U. Early determinants of childhood overweight and adiposity in a birth cohort study: role of breast-feeding. Int J Obes Relat Metab Disord. 2003 Feb;27(2):162-72. — View Citation
Cartagena DC, Ameringer SW, McGrath J, Jallo N, Masho SW, Myers BJ. Factors contributing to infant overfeeding with Hispanic mothers. J Obstet Gynecol Neonatal Nurs. 2014 Mar-Apr;43(2):139-59. doi: 10.1111/1552-6909.12279. Epub 2014 Feb 6. Review. — View Citation
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.
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. — View Citation
Gill SL. Breastfeeding by Hispanic women. J Obstet Gynecol Neonatal Nurs. 2009 Mar-Apr;38(2):244-52. doi: 10.1111/j.1552-6909.2009.01013.x. Review. — View Citation
Gurnani M, Birken C, Hamilton J. Childhood Obesity: Causes, Consequences, and Management. Pediatr Clin North Am. 2015 Aug;62(4):821-40. doi: 10.1016/j.pcl.2015.04.001. Epub 2015 May 23. Review. — View Citation
Kelishadi R, Farajian S. The protective effects of breastfeeding on chronic non-communicable diseases in adulthood: A review of evidence. Adv Biomed Res. 2014 Jan 9;3:3. doi: 10.4103/2277-9175.124629. eCollection 2014. Review. — View Citation
Linares AM, Hall L, Ashford K. Psychometric Testing of the Autonomy and Relatedness Inventory-Spanish Version. J Nurs Meas. 2015;23(1):E27-37. doi: 10.1891/1061-3749.23.1.E27. — View Citation
Linares AM, Rayens MK, Dozier A, Wiggins A, Dignan MB. Factors influencing exclusive breastfeeding at 4 months postpartum in a sample of urban Hispanic mothers in Kentucky. J Hum Lact. 2015 May;31(2):307-14. doi: 10.1177/0890334414565711. Epub 2015 Jan 16. — View Citation
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
Meedya S, Fahy K, Kable A. Factors that positively influence breastfeeding duration to 6 months: a literature review. Women Birth. 2010 Dec;23(4):135-45. doi: 10.1016/j.wombi.2010.02.002. Epub 2010 Mar 17. Review. — View Citation
Nommsen-Rivers LA, Cohen RJ, Chantry CJ, Dewey KG. The Infant Feeding Intentions scale demonstrates construct validity and comparability in quantifying maternal breastfeeding intentions across multiple ethnic groups. Matern Child Nutr. 2010 Jul 1;6(3):220-7. doi: 10.1111/j.1740-8709.2009.00213.x. — View Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. — View Citation
Palou A, Sánchez J, Picó C. Nutrient-gene interactions in early life programming: leptin in breast milk prevents obesity later on in life. Adv Exp Med Biol. 2009;646:95-104. doi: 10.1007/978-1-4020-9173-5_10. Review. — View Citation
Spatz DL. Preventing obesity starts with breastfeeding. J Perinat Neonatal Nurs. 2014 Jan-Mar;28(1):41-50. doi: 10.1097/JPN.0000000000000009. Review. — View Citation
Thulier D. A call for clarity in infant breast and bottle-feeding definitions for research. J Obstet Gynecol Neonatal Nurs. 2010 Nov-Dec;39(6):627-34. doi: 10.1111/j.1552-6909.2010.01197.x. — View Citation
Wambach KA, Aaronson L, Breedlove G, Domian EW, Rojjanasrirat W, Yeh HW. A randomized controlled trial of breastfeeding support and education for adolescent mothers. West J Nurs Res. 2011 Jun;33(4):486-505. doi: 10.1177/0193945910380408. Epub 2010 Sep 27. — View Citation
Wright AL, Holberg C, Taussig LM. Infant-feeding practices among middle-class Anglos and Hispanics. Pediatrics. 1988 Sep;82(3 Pt 2):496-503. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Acculturation | 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. | At Baseline around 30 weeks of pregnancy | |
Primary | Exclusive breastfeeding (EBF) | 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. | From birth to 6 months old | |
Secondary | Intention to breastfeed | 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. | Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy. | |
Secondary | Social support | 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. | prenatal at baseline and postnatal at 1 month post partum | |
Secondary | Knowledge of breastfeeding | 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. | Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy. | |
Secondary | Breastfeeding Self-Efficacy | 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. | Post natal at 1, 3, 6 months postpartum only when woman was breastfeeding. |
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