Childhood Risk Reduction Program in Hispanics

NCT03903146 | Completed Results

• 1 other identifier: 16-0164-P2H
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Feeding, Exclusive

Keywords

Breastfeeding; Exclusive breastfeeding; Hispanic Women; Kentucky

Outcome Measures

Primary Outcomes (3)

• 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.

  At hospital discharge

• 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.

  3 months

• 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.

  6 months

Secondary Outcomes (4)

• Intention to Breastfeed

  Prenatal: At baseline (around 30 weeks of pregnancy) and after 37 week of pregnancy.

• Social Support

  prenatal at baseline

• Knowledge of Breastfeeding

  Prenatal: At baseline (around 30 weeks of pregnancy) and after 37 weeks of pregnancy.

• Breastfeeding Self-Efficacy

  Post natal at 1, 3, 6 months postpartum only when woman was breastfeeding.

Other Outcomes (1)

• Acculturation

  At Baseline around 30 weeks of pregnancy

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Early Childhood Obesity Risk-Reduction Program in Hispanics BEHAVIORAL

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).

Also known as: Promoting Exclusive breastfeeding in Hispanic Mothers

Intervention Group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ana Maria Linares: lead

Related Publications (19)

• 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.

  PMID: 26210619 BACKGROUND

• 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.

  PMID: 24600594 BACKGROUND

• 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.

  PMID: 24570244 BACKGROUND

• Bergmann KE, Bergmann RL, Von Kries R, Bohm 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. doi: 10.1038/sj.ijo.802200.

  PMID: 12586995 BACKGROUND

• Palou A, Sanchez J, Pico 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.

  PMID: 19536667 BACKGROUND

• Spatz DL. Preventing obesity starts with breastfeeding. J Perinat Neonatal Nurs. 2014 Jan-Mar;28(1):41-50. doi: 10.1097/JPN.0000000000000009.

  PMID: 24476651 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24502196 BACKGROUND

• Wright AL, Holberg C, Taussig LM. Infant-feeding practices among middle-class Anglos and Hispanics. Pediatrics. 1988 Sep;82(3 Pt 2):496-503.

  PMID: 3405686 BACKGROUND

• 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.

  PMID: 19323721 BACKGROUND

• 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.

  PMID: 25596411 BACKGROUND

• 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.

  PMID: 21044147 BACKGROUND

• 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.

  PMID: 20929494 BACKGROUND

• 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.

  PMID: 26269139 BACKGROUND

• 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.

  PMID: 20876551 BACKGROUND

• 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. doi: 10.1177/0884217503258459.

  PMID: 14649593 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20299299 BACKGROUND

• 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 21. No abstract available.

  PMID: 29928830 RESULT

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Ana Maria Linares, PI
• Organization: University of Kentucky

am.linares@uky.edu

8593234726

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Nursing

Model Details: Participants were randomly assigned to intervention or control groups.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: March 23, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share