Home Visiting for Low Income, Pregnant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, Los Angeles
Sponsor:
Collaborators:
W.K. Kellogg Foundation
Center for HIV Identification, Prevention, and Treatment Services
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01687634
First received: September 7, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Pregnant Women
Nutrition During Pregnancy
Breast Feeding
Newborns
Behavioral: In-home Mentor Mother visits
Behavioral: Health Information Mailings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Home Visiting for Low Income, Pregnant Women

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Exclusive breastfeeding [ Time Frame: Six months post-birth ] [ Designated as safety issue: No ]
  • Maternal BMI [ Time Frame: Six months post-birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol, tobacco, and drug use in pregnancy [ Time Frame: one week post-birth ] [ Designated as safety issue: No ]
  • World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference [ Time Frame: one week post-birth ] [ Designated as safety issue: No ]
  • World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference [ Time Frame: six months post-birth ] [ Designated as safety issue: No ]
  • Adherence to prenatal clinic visits [ Time Frame: one week post-birth ] [ Designated as safety issue: No ]
  • Adherence to well-baby clinic visits [ Time Frame: six months post-birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: October 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Health Information Mailings
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
Behavioral: Health Information Mailings
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.

Detailed 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.

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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.

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HEALTH INFORMATION MAILINGS:

Pregnant women will receive twice-monthly mailing that will provide information about pregnancy, breastfeeding, nutrition, and infant care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687634

Contacts
Contact: Deborah Brownstone, LCSW 213-480-4511 dbrownstone@mednet.ucla.edu
Contact: Jasmin Medel 213-480-4511 jmedel@mednet.ucla.edu

Locations
United States, California
Robert F. Kennedy Schools Recruiting
Los Angeles, California, United States, 90010
Contact: Jasmin Medel    213-480-4511    jmedel@mednet.ucla.edu   
Contact: Julie Han, BA    213-480-4511    juliehan@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
W.K. Kellogg Foundation
Center for HIV Identification, Prevention, and Treatment Services
Investigators
Principal Investigator: Mary Jane Rotheram-Borus, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Mary Jane Rotheram-Borus, Director, Global Center for Children and Families, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01687634     History of Changes
Other Study ID Numbers: P3018725
Study First Received: September 7, 2012
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
pregnancy
home healthcare visits
breast feeding
nutrition
community health workers

ClinicalTrials.gov processed this record on October 21, 2014