Home Visiting for Low Income, Pregnant Women

NCT01687634 | Completed

• 1 other identifier: P3018725
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women; Nutrition During Pregnancy; Breast Feeding; Newborns

Keywords

pregnancy; home healthcare visits; breast feeding; nutrition; community health workers

Outcome Measures

Primary Outcomes (2)

• Exclusive breastfeeding

  Six months post-birth

• Maternal BMI

  Six months post-birth

Secondary Outcomes (5)

• Alcohol, tobacco, and drug use in pregnancy

  one week post-birth

• World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference

  one week post-birth

• World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference

  six months post-birth

• Adherence to prenatal clinic visits

  one week post-birth

• Adherence to well-baby clinic visits

  six months post-birth

Study Arms (2)

In-home Mentor Mother visits

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.

Behavioral: In-home Mentor Mother visits

Health Information Mailings

EXPERIMENTAL

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

Behavioral: Health Information Mailings

Interventions

In-home Mentor Mother visits BEHAVIORAL

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

Health Information Mailings BEHAVIORAL

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

Health Information Mailings

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Currently pregnant;
• Living in the Pico/Union Koreatown community;
• Ability to provide informed consent;
• Speaks English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• W.K. Kellogg Foundation: collaborator
• Center for HIV Identification, Prevention, and Treatment Services: collaborator

Study Sites (1)

Robert F. Kennedy Schools

Los Angeles, California, 90010, United States

Location

Related Publications (2)

• Rotheram-Fuller EJ, Swendeman D, Becker KD, Daleiden E, Chorpita B, Harris DM, Mercer NT, Rotheram-Borus MJ. Replicating Evidence-Based Practices with Flexibility for Perinatal Home Visiting by Paraprofessionals. Matern Child Health J. 2017 Dec;21(12):2209-2218. doi: 10.1007/s10995-017-2342-8.

  PMID: 28755042 DERIVED

• Rotheram-Fuller E, Swendeman D, Becker K, Daleiden E, Chorpita B, Youssef MK, Rotheram-Borus MJ. Adapting Current Strategies to Implement Evidence-Based Prevention Programs for Paraprofessional Home Visiting. Prev Sci. 2017 Jul;18(5):590-599. doi: 10.1007/s11121-017-0787-z.

  PMID: 28451922 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Mary Jane Rotheram-Borus, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Global Center for Children and Families

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 19, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)