Home Visiting for Low Income, Pregnant Women

Breast Feeding Clinical Trial

Official title:

Home Visiting for Low Income, Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687634
• Other study ID #: P3018725
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: May 12, 2017
• Start date: October 2012
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Newborns
• Nutrition During Pregnancy
• Pregnant Women

Intervention

Behavioral:
• 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.
• Health Information Mailings
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.

Locations

Country	Name	City	State
United States	Robert F. Kennedy Schools	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Center for HIV Identification, Prevention, and Treatment Services, W.K. Kellogg Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding		Six months post-birth
Primary	Maternal BMI		Six months post-birth
Secondary	Alcohol, tobacco, and drug use in pregnancy		one week post-birth
Secondary	World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference		one week post-birth
Secondary	World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference		six months post-birth
Secondary	Adherence to prenatal clinic visits		one week post-birth
Secondary	Adherence to well-baby clinic visits		six months post-birth