Home Visiting for Low Income, Pregnant Women

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01687634
Collaborator
W.K. Kellogg Foundation (Other), Center for HIV Identification, Prevention, and Treatment Services (Other)
203
1
2
45
4.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: In-home Mentor Mother visits
  • Behavioral: Health Information Mailings
N/A

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.


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.

Study Design

Study Type:
Interventional
Actual Enrollment :
203 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Home Visiting for Low Income, Pregnant Women
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Exclusive breastfeeding [Six months post-birth]

  2. Maternal BMI [Six months post-birth]

Secondary Outcome Measures

  1. Alcohol, tobacco, and drug use in pregnancy [one week post-birth]

  2. World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference [one week post-birth]

  3. World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference [six months post-birth]

  4. Adherence to prenatal clinic visits [one week post-birth]

  5. Adherence to well-baby clinic visits [six months post-birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Robert F. Kennedy Schools Los Angeles California United States 90010

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Jane Rotheram-Borus, Director, Global Center for Children and Families, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01687634
Other Study ID Numbers:
  • P3018725
First Posted:
Sep 19, 2012
Last Update Posted:
May 16, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Mary Jane Rotheram-Borus, Director, Global Center for Children and Families, University of California, Los Angeles

Study Results

No Results Posted as of May 16, 2017