Childhood Risk Reduction Program in Hispanics
Childhood Risk Reduction Program in Hispanics
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.
The feasibility of a tailored community-based intervention, entitled Early Childhood Obesity
 Risk-Reduction Program in Hispanics (ECOR-H), was tested. The ECOR-H provided mothers with
 culturally tailored, self-management risk-reduction modules, and with continued peer
 counselor (PC) and professional lactation consultant support to develop personal skill-set to
 "take control" of modifiable behaviors and help participants to exclusively breastfeed for a
 longer time and delay the introduction of solid food to the infants. The study was conducted
 in the University of Kentucky (UK) Polk Dalton Clinic and in the Birthing Center of UK Albert
 B. Chandler Hospital. A convenient sample of 39 self-identified Hispanic pregnant women were
 recruited and randomly assigned to intervention and standard care groups (Intervention n = 20
 ; Control n=19).

 Trained Research Personnel (RP) approached and screened women for eligibility in the waiting
 prenatal area, which was exclusively used by pregnant women--while waiting for prenatal care
 appointments. Screening for eligibility was accomplished using a checklist that contains
 eligibility criteria. If the woman satisfied the eligibility criteria, the potential
 participant was invited to go to a private room in the clinic available for this purpose and
 the research staff provided a review and explanation of the study with an invitation to
 participate. If the person stated that was not interested, the research staff asked if can
 share the reason(s) why of the decision and collected the information in the log track of
 potential recruitment contacted. Then the research staff thanked the time and ended the
 conversation. Women who agreed to participate were scheduled for an appointment at another
 convenient time at the participant's home or clinic to provide informed consent and signed a
 HIPAA authorization. Since the potential participants included English/Spanish speaking
 participants, the informed consent, HIPPA authorization, and interview materials and
 intervention sessions were provided in the language in which the subject was most proficient.
 The parental permission for the infant was included in the informed consent that the mother
 signed when agreed to participate in the study. The consent form explains that this study
 would collect information on the infant from the medical record. The type of information that
 would be collected about the infant was also described in the HIPAA authorization form. The
 informed consent form provided the overall goal of the research; a brief description of the
 research; the type of survey that would be conducted in each encounter; the infant assessment
 for the anthropometric measurements of weight, length, and head circumference, and the
 mother's BMI. The explanation also described the minimal risks to participants and the
 potential benefits, procedures to assure confidentiality, and the voluntary nature of
 participation and how the confidentiality of the information that participants provide during
 the study would be maintained. It was also necessary to collect the name and a telephone
 number for contact information and follow-up encounters. The research staff explained that
 this information would be used only for research purposes and to send reminding of time,
 date, and place of the follow-up interviews, and it will be destroyed by the end of the
 study.

 All identifiers such as name, address, date of birth, telephone number, medical record
 number, and a code number were included in a private list and saved in a Microsoft Excel
 program with password protection to which only the PI and research staff had access. The
 Microsoft Excel file was opened only in encrypted computers located in the office of the PI
 and research staff in the University of Kentucky College of Nursing. Only staff certified in
 human subjects research and who were listed as study personnel with the University of
 Kentucky Institutional Review Board (UK IRB) were allowed access to participant data. When
 the study was completed, the data was de-identified prior to data sharing.

 After providing informed consent, the participant completed a baseline study survey.
 Following the baseline interview, the research staff informed the PI weekly of the new number
 of participants recruited. The PI randomly assigned participants to intervention and standard
 care groups following randomization procedures. Data collection was similar for both groups
 (standard care and intervention) and was obtained independently by research staff at 30 weeks
 of pregnancy (T-1), at 37 or more weeks of pregnancy (T-2), chart review of mother/infant
 medical record at birth (T-3), between 2-4 weeks after birth (T-4), and at three (T-5) and
 six (T-6) months after the birth. Randomization: After the baseline interview (T-1), the
 participant was randomly assigned to the standard of care group or standard care plus ECOR-H
 intervention group. The random assignment schedule was stratified according to whether the
 woman was a first-time mother or has other children; this allowed equal numbers within each
 of these two strata to be assigned to each of the two treatment conditions. The
 biostatistician prepared envelopes that contain the treatment assignments, one set for each
 stratum. Within each stratum, the treatment assignments were set in blocks of 10 (i.e., 5
 assignments to each of the treatment conditions). Though the total recruitment target was 39
 women, it was not known what percentage will be first-time mothers, so the investigators
 created at least 3 blocks of 10 mothers for each of the two strata. The blocks in the
 randomization schedule ensured that investigators have approximately equivalent numbers of
 mothers in each of the treatment and standard care groups at all stages of data collection
 for both strata. The PI opened the sealed envelope based in the parity of the participant;
 each envelope contained a card with "Standard care" or "Intervention." The PI informed the PC
 the participants that have been assigned to initiate the intervention. The PC initiated
 contact with the participant in a time frame not longer than a week. The research personnel
 who collected data was blinded to the treatment condition of the participants. A script was
 read in each data collection session to request the participant to avoid sharing with the
 research staff if she was or not receiving the visit of the PC or professional lactation
 consultant.

 Data Analysis: Given the descriptive nature of this feasibility study, no power analysis was
 warranted. However, the feasibility study informed effect sizes that will be used to estimate
 statistical power for future studies, including a planned R01 submission. Descriptive
 analysis will be accomplished using means and standard deviations or frequency distributions.
 Differences in baseline demographic and personal characteristics between the intervention and
 usual care groups will be assessed using two-sample t-tests, Mann-Whitney U tests, or
 chi-square tests of association to verify that the randomization yielded comparable groups
 from this population. Measures of feasibility (including number of participants completing
 the intervention sessions and entire study) will be examined. Logistic regression with
 demographics and personal characteristics as covariates will be used to discern whether there
 is a difference in the likelihood of breastfeeding initiation, duration and exclusivity
 between the intervention and usual care group. Qualitative methods will be used to assess
 factors impacting recruitment, adherence, and acceptability of the intervention.
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.