BreastfeedingNCT03442517
The LATCHING Pilot Project
A study testing Behavior Lifestyle Intervention and Usual prenatal care in people with Breastfeeding, run by University of Kansas Medical Center at 3 sites in United States.
Trial summary
The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Behavior Lifestyle Intervention and Usual prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2017to 5 May 2019
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
- Speak and understand English
Who cannot join
- Women with pregnancies conceived using fertility treatments, those at high risk for pre-term delivery, those with multiple gestation (ie. twins, triplets, etc), or pregnancies complicated by morbid obesity (BMI>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
- Women who have previously exclusively breastfed an infant for three or more months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Priority Care Pediatrics, LLC
Kansas City, Missouri, 64155
Northland Obstetrics & Gynecology, Inc.
Liberty, Missouri, 64068
About this study
Official title: Learning About Techniques to Create Healthy Infants Through Nutrition and Proper Growth
The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy.
- Conditions
- Breastfeeding
- Being tested
- Behavior Lifestyle Intervention, Usual prenatal care
- Keywords
- group-based counseling, phone counseling, conference calls
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Lifestyle InterventionBehavioural
Also called Group-based phone counseling
Participants will be involved in group-based counseling. Sessions will be about 1 hour each and comprise up to 10 people. The sessions will be led by a trained health educator. The calls will be a chance for participants to discuss challenges with breastfeeding, problem solving skills, educational information, and discuss balanced diet topics.
Usual prenatal careOther
Participants will receive the standard education given by their OBGYN or other healthcare provider. No additional breastfeeding, nutrition or postpartum weight loss education will be provided to participants by the investigators during pregnancy. After delivery, participants will follow normal pediatric visit schedule.
| Study group | Role | What they receive |
|---|---|---|
| Group-based phone counseling (GBPC) | Experimental | Participants will take part in weekly group-based phone counseling sessions for 6 weeks starting between 16-30 weeks of pregnancy. Receives: Behavioral: Behavior Lifestyle Intervention |
| Usual prenatal care | Active comparator | Participants will continue their usual prenatal care. Receives: Other: Usual prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in infant feeding progression
Measured: Month 6
Proportion of women exclusively breastfeeding
Measured: Month 6
Proportion of women who introduce solids
Measured: Month 4
Secondary outcomes (3)
Subject satisfaction and acceptability of intervention
Structured interviews will be used to determine subject satisfaction. Structured interviews will obtain descriptive data regarding problems encountered by participants during the intervention, areas of intervention strength and weakness, information participants found helpful and information participants wish they had been given during the intervention, and ways the overall intervention could be improved.
Measured: Week 24
Intervention compliance
Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions.
Measured: Week 24
Study Retention
Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start29 Apr 2017
- Primary completion5 May 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Hull, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442517
- Sponsor's protocol ID
- STUDY00140506
- Status last verified
- May 2019
- First submitted
- 20 Dec 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cauble JS, Herman A, Wick J, Goetz J, Daley CM, Sullivan DK, Hull HR. A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial. BMC Pregnancy Childbirth. 2021 Jul 22;21(1):521. doi: 10.1186/s12884-021-03976-2.
PubMed 34294051
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning About Techniques to Create Healthy Infants Through Nutrition and Proper Growth
- ClinicalTrials.gov ID
- NCT03442517
- Acronym / sponsor ID
- STUDY00140506
- Conditions
- Breastfeeding
- Keywords
- group-based counseling, phone counseling, conference calls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based phone counseling (GBPC) | Experimental | Behavioral: Behavior Lifestyle InterventionParticipants will take part in weekly group-based phone counseling sessions for 6 weeks starting between 16-30 weeks of pregnancy. |
| Usual prenatal care | Active comparator | Other: Usual prenatal careParticipants will continue their usual prenatal care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
- Speak and understand English
Key exclusion criteria (2 listed)
- Women with pregnancies conceived using fertility treatments, those at high risk for pre-term delivery, those with multiple gestation (ie. twins, triplets, etc), or pregnancies complicated by morbid obesity (BMI>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
- Women who have previously exclusively breastfed an infant for three or more months
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 |
|---|---|---|
| Behavior Lifestyle InterventionAlso: Group-based phone counselingParticipants will be involved in group-based counseling. Sessions will be about 1 hour each and comprise up to 10 people. The sessions will be led by a trained health educator. The calls will be a chance for participants to discuss challenges with breastfeeding, problem solving skills, educational information, and discuss balanced diet topics. | Behavioural | Group-based phone counseling (GBPC) |
| Usual prenatal careParticipants will receive the standard education given by their OBGYN or other healthcare provider. No additional breastfeeding, nutrition or postpartum weight loss education will be provided to participants by the investigators during pregnancy. After delivery, participants will follow normal pediatric visit schedule. | Other | Usual prenatal care |
Primary outcome
Differences in infant feeding progression
Time frame: Month 6
Proportion of women exclusively breastfeeding
Time frame: Month 6
Proportion of women who introduce solids
Time frame: Month 4
3 secondary outcomes
Subject satisfaction and acceptability of intervention
Time frame: Week 24
Intervention compliance
Time frame: Week 24
Study Retention
Time frame: Month 6
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 30 May 2019.
- Derived from this study: PubMed 34294051Cauble JS, Herman A, Wick J, Goetz J, Daley CM, Sullivan DK, Hull HR. A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial. BMC Pregnancy Childbirth. 2021 Jul 22;21(1):521. doi: 10.1186/s12884-021-03976-2.
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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.
Holly Hull, PhD principal investigator
University of Kansas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Lifestyle Intervention and Usual prenatal care in people with Breastfeeding, run by University of Kansas Medical Center at 3 sites 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 2 inclusion and 2 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Differences in infant feeding progression (time frame: Month 6). The study lists 3 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 NCT03442517, which also lists 1 linked publication.
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 30 May 2019.