ClinicalTrials.gg
CompletedNCT03442517Updated May 30, 2019

The LATCHING Pilot Project

An interventional study of Behavior Lifestyle Intervention and Usual prenatal care in Breastfeeding, sponsored by University of Kansas Medical Center. Completed at 3 sites in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 251 studies in Breast Feeding with a site in United States — 44 open to participants now, 49 under way, none of them phase 3. Breast Feeding · United States.

Enrollment
133rd of 202
46 · median 83
Started
2017
with 19 others
No phase
164 of 251
27 open now
Registered
110th of 251
by date

Among the 251 studies in Breast Feeding with a site in United States, this one is the 133rd largest by enrollment of the 202 interventional ones that give a count, is one of 20 that started in 2017, is one of 164 with no phase, and was the 110th registered.

Breast Feeding

1,082 studies on the registry are indexed under Breast Feeding; 218 are open to participants now.

Browse Breast Feeding studies →

Open to participants now

44 of the 251 studies in Breast Feeding with a site in United States are open now. Recruiting first, the newest first:

39 more — sign in →

All 44 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 128 Breast Feeding studies recruiting now, 67 (52%) set no upper age limit and 59 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.

This study: 18 Years to 35 Years · female · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Breastfeeding

Browse trials for

Keywords

  • group-based counseling
  • phone counseling
  • conference calls
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
  • Speak and understand English

Exclusion criteria

Exclusion Criteria:

  • 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 (>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
  • Women who have previously exclusively breastfed an infant for three or more months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Group-based phone counseling (GBPC)

    Participants will take part in weekly group-based phone counseling sessions for 6 weeks starting between 16-30 weeks of pregnancy.

    Behavioral: Behavior Lifestyle Intervention

  • Active comparator
    Usual prenatal care

    Participants will continue their usual prenatal care.

    Other: Usual prenatal care

Interventions

  • BehavioralBehavior Lifestyle Intervention

    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.

    Also known as: Group-based phone counseling

  • OtherUsual prenatal care

    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.

06

What researchers measure

Primary outcomes

  1. Differences in infant feeding progression

    Time frame: Month 6

  2. Proportion of women exclusively breastfeeding

    Time frame: Month 6

  3. Proportion of women who introduce solids

    Time frame: Month 4

Secondary outcomes

  1. 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.

    Time frame: Week 24

  2. Intervention compliance

    Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions.

    Time frame: Week 24

  3. Study Retention

    Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.

    Time frame: Month 6

Other outcomes

  1. Differences in infant feeding progression

    Time frame: Week 2

  2. Differences in infant feeding progression

    Time frame: Month 2

  3. Differences in infant feeding progression

    Time frame: Month 4

07

Study locations

3 sites
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Priority Care Pediatrics, LLC
    Kansas City, Missouri 64155, United States
  • Northland Obstetrics & Gynecology, Inc.
    Liberty, Missouri 64068, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in May 2019, 24 months.

Of 503 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 24 months is above that.

Counting every sponsor, half of 511 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Feb 22, 2018
StartActual
Apr 29, 2017
Primary completionActual
May 5, 2019
CompletionActual
May 5, 2019
Last update
May 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03442517
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Apr 29, 2017
Primary completion
May 5, 2019
Completion
May 5, 2019
Last update
May 30, 2019

Study contacts

Holly Hull, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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