Childhood Risk Reduction Program in Hispanics
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
Paskutinį kartą patikrinta: | 03/31/2019 |
Pirmasis pateikimas: | 03/28/2019 |
Numatytas registravimas pateiktas: | 04/01/2019 |
Pirmas paskelbtas: | 04/03/2019 |
Paskutinis atnaujinimas pateiktas: | 04/01/2019 |
Paskutinis atnaujinimas paskelbtas: | 04/03/2019 |
Faktinė studijų pradžios data: | 03/09/2016 |
Numatoma pirminio užbaigimo data: | 10/30/2018 |
Numatoma studijų užbaigimo data: | 10/30/2018 |
Būklė ar liga
Intervencija / gydymas
Behavioral: Intervention Group
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Intervention Group 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: Intervention Group 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). |
No Intervention: Control Group 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. |
Tinkamumo kriterijai
Tinkamos studijoms lytys | Female |
Priima sveikus savanorius | Taip |
Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Exclusive breastfeeding (EBF) [From birth to 6 months old]
Antrinės rezultatų priemonės
1. Intention to breastfeed [Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy.]
2. Social support [prenatal at baseline and postnatal at 1 month post partum]
3. Knowledge of breastfeeding [Prenatal: At baseline around 30 weeks of pregnancy and aftr 37 week of pregnancy.]
4. Breastfeeding Self-Efficacy [Post natal at 1, 3, 6 months postpartum only when woman was breastfeeding.]
Kitos rezultato priemonės
1. Acculturation [At Baseline around 30 weeks of pregnancy]