Clinical trial NCT01687634: Home Visiting for Low Income, Pregnant Women
Official title: Home Visiting for Low Income, Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Nutrition During Pregnancy
Breast Feeding
Newborns
Keywords: pregnancy
home healthcare visits
breast feeding
nutrition
community health workers
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: W.K. Kellogg Foundation
name: Center for HIV Identification, Prevention, and Treatment Services
First posted: 2012-09-19
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: Six months post-birth
measure: Maternal BMI
timeFrame: Six months post-birth
Secondary outcomes:
measure: Alcohol, tobacco, and drug use in pregnancy
timeFrame: one week post-birth
measure: World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
timeFrame: one week post-birth
measure: World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
timeFrame: six months post-birth
measure: Adherence to prenatal clinic visits
timeFrame: one week post-birth
measure: Adherence to well-baby clinic visits
timeFrame: six months post-birth
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Robert F. Kennedy Schools
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Mary Jane Rotheram-Borus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.