Breast Feeding Clinical Trial
Official title:
Home Visiting for Low Income, Pregnant Women
In the Pico-Union/Koreatown community of Los Angeles investigators are designing a
preventive health care model that increases the opportunities for families to make healthy
choices -- in their homes, schools & communities. The project's key element is: Lay
community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make
home visits to pregnant mothers & newly-delivered mothers who have agreed to participate in
the research study.
Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months
post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use
during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare
adherence.
Investigators will implement the study with 6 MMs, who will maintain an average caseload of
16 women each across an 18-month period. Each participant will be visited (or receive the
intervention by telephone) twice per month.
Separate Assessment Team members will conduct assessments at: Baseline, within a week of
birth of the target child, and 6 months from birth.
After participant mothers have been recruited, screened, and consented into the study, each
woman will be contacted by a member of the Assessment Team to schedule the in-home Baseline
Assessment. The Baseline Assessment will take approximately 90 minutes to complete.
Follow-up Assessments will take place: within a week of delivery and 6 months after
delivery. Interviews will be audio-recorded for quality assurance purposes. The domains of
the Follow-up Assessments will be 1) maternal weight, height, and eating and exercise
routines; 2) feeding routines, style, and frequency; 3) substance use; and 4) adherence to
health care prenatally and postnatally, immunizations, and illnesses for mothers and babies.
Secondarily, investigators will assess the mother's pregnancy, general health, mental
health, social support, the father of the child, use of alternative medicine and health
care, reproductive health, HIV, relationships and violence, baseline knowledge of antenatal
health, baseline knowledge of delivery health, and baseline stated future plans.
All in-home interviews will take place in a private room or area of the participant's home.
If an in-home interview is not practical or appropriate for any reason, the interviewer will
conduct the interview at the Robert F. Kennedy Community Schools campus, UCLA, or another
site.
Assessment team in-home interviews will be audio-recorded for quality assurance &
supervision purposes. Telephone interviews will not be audio-recorded.
IN-HOME (OR TELEPHONE) MENTOR MOTHER INTERVENTION VISITS:
Each participant will be assigned to a Mentor Mother (MM). Participants will receive a
series of twice-monthly, pre- and post-natal, in-home (or telephone call) intervention
visits, for the study period of 12 months, from her assigned MM. The MM will measure the
mother's height & weight at each intervention home visit, then proceed to deliver one of the
Intervention Topics (e.g. nutrition, substance use awareness, infant development etc.).
After the baby is born, the Mentor Mother will continue to record the mother's weight and
height, and will also measure and weigh the infant, entering that data into the study mobile
phone. These intervention visits (or phone calls) will last for approximately 1 hour each.
The MM will address any concerns or questions the mother has, provide referrals to community
resources as necessary, and leave handouts for the participant mother based on the day's
intervention topic and/or the participant mother's questions that day.
HEALTH INFORMATION MAILINGS:
Pregnant women will receive twice-monthly mailing that will provide information about
pregnancy, breastfeeding, nutrition, and infant care.
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