Overview

This trial is active, not recruiting.

Conditions pregnant women, nutrition during pregnancy, breast feeding, newborns
Treatments in-home mentor mother visits, health information mailings
Sponsor University of California, Los Angeles
Collaborator W.K. Kellogg Foundation
Start date October 2012
End date July 2016
Trial size 125 participants
Trial identifier NCT01687634, P3018725

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.
in-home mentor mother visits
Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.
(Experimental)
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
health information mailings
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.

Primary Outcomes

Measure
Exclusive breastfeeding
time frame: Six months post-birth
Maternal BMI
time frame: Six months post-birth

Secondary Outcomes

Measure
Alcohol, tobacco, and drug use in pregnancy
time frame: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
time frame: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
time frame: six months post-birth
Adherence to prenatal clinic visits
time frame: one week post-birth
Adherence to well-baby clinic visits
time frame: six months post-birth

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 18 years of age or older; - Currently pregnant; - Living in the Pico/Union Koreatown community; - Ability to provide informed consent; - Speaks English or Spanish Exclusion Criteria: - Under 18 years of age; - Not currently pregnant; - Not living in the Pico/Union Koreatown community; - Unable to provide informed consent; - Does not speak English or Spanish

Additional Information

Official title Home Visiting for Low Income, Pregnant Women
Principal investigator Mary Jane Rotheram-Borus, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.