Clinical trial NCT03903146: Childhood Risk Reduction Program in Hispanics
Official title: Early Childhood Obesity Risk Reduction Program in Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding, Exclusive
Keywords: Breastfeeding
Exclusive breastfeeding
Hispanic Women
Kentucky
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to intervention or control groups.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Exclusive Breastfeeding (EBF)
timeFrame: At hospital discharge
measure: Exclusive Breastfeeding (EBF)
timeFrame: 3 months
measure: Exclusive Breastfeeding (EBF)
timeFrame: 6 months
Secondary outcomes:
measure: Intention to Breastfeed
timeFrame: Prenatal: At baseline (around 30 weeks of pregnancy) and after 37 week of pregnancy.
measure: Social Support
timeFrame: prenatal at baseline
measure: Knowledge of Breastfeeding
timeFrame: Prenatal: At baseline (around 30 weeks of pregnancy) and after 37 weeks of pregnancy.
measure: Breastfeeding Self-Efficacy
timeFrame: Post natal at 1, 3, 6 months postpartum only when woman was breastfeeding.
Other outcomes:
measure: Acculturation
timeFrame: At Baseline around 30 weeks of pregnancy
Locations:
Study officials:
References:
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