Pregnant WomenNCT01687634
Home Visiting for Low Income, Pregnant Women
A study testing In-home Mentor Mother visits and Health Information Mailings in people with Pregnant Women and Nutrition During Pregnancy, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Nutrition During Pregnancy, Breast Feeding
- What is being tested?
- In-home Mentor Mother visits and Health Information Mailings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Currently pregnant;
- Living in the Pico/Union Koreatown community;
- Ability to provide informed consent;
- Speaks English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert F. Kennedy Schools
Los Angeles, California, 90010
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pregnant Women, Nutrition During Pregnancy, Breast Feeding, Newborns
- Being tested
- In-home Mentor Mother visits, Health Information Mailings
- Keywords
- pregnancy, home healthcare visits, breast feeding, nutrition, community health workers
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home Mentor Mother visitsBehavioural
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 MailingsBehavioural
Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Information Mailings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
Measured: Six months post-birth
Maternal BMI
Measured: Six months post-birth
Secondary outcomes (5)
Alcohol, tobacco, and drug use in pregnancy
Measured: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
Measured: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
Measured: six months post-birth
Adherence to prenatal clinic visits
Measured: one week post-birth
Adherence to well-baby clinic visits
Measured: six months post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- W.K. Kellogg Foundation, Center for HIV Identification, Prevention, and Treatment Services
- Responsible party
- Principal investigator, Mary Jane Rotheram-Borus, University of California, Los Angeles
- Investigators
- Mary Jane Rotheram-Borus, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687634
- Sponsor's protocol ID
- P3018725
- Status last verified
- May 2017
- First submitted
- 7 Sep 2012
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be be made available on the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS) website.
Publications
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.
PubMed 28755042Rotheram-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.
PubMed 28451922
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Visiting for Low Income, Pregnant Women
- ClinicalTrials.gov ID
- NCT01687634
- Acronym / sponsor ID
- P3018725
- Conditions
- Pregnant Women, Nutrition During Pregnancy, Breast Feeding, Newborns
- Keywords
- pregnancy, home healthcare visits, breast feeding, nutrition, community health workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- W.K. Kellogg Foundation, Center for HIV Identification, Prevention, and Treatment Services
- Study start
- Oct 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
----------------------------------------------------
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-home Mentor Mother visits | Experimental | Behavioral: In-home Mentor Mother visitsPregnant 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 | Experimental | Behavioral: Health Information MailingsPregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older;
- Currently pregnant;
- Living in the Pico/Union Koreatown community;
- Ability to provide informed consent;
- Speaks English or Spanish
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home Mentor Mother visitsPregnant 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. | Behavioural | In-home Mentor Mother visits |
| Health Information MailingsPregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care. | Behavioural | Health Information Mailings |
Primary outcome
Exclusive breastfeeding
Time frame: Six months post-birth
Maternal BMI
Time frame: Six months post-birth
5 secondary outcomes
Alcohol, tobacco, and drug use in pregnancy
Time frame: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
Time frame: one week post-birth
World Health Organization infant age-standardized weight, length, weight-for-length, and head circumference
Time frame: six months post-birth
Adherence to prenatal clinic visits
Time frame: one week post-birth
Adherence to well-baby clinic visits
Time frame: six months post-birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 28755042Rotheram-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.
- Derived from this study: PubMed 28451922Rotheram-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.
- Individual participant dataSharing planned: Yes. Data will be be made available on the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS) website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jane Rotheram-Borus, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home Mentor Mother visits and Health Information Mailings in people with Pregnant Women and Nutrition During Pregnancy, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: Six months post-birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.