Overweight or ObesityNCT06372860
DPP Feasibility Study of Breastfeeding - eMOMS 2.0
A study testing Diabetes Prevention Program and Breastfeeding in people with Overweight or Obesity and Pregnancy, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overweight or Obesity, Pregnancy
- What is being tested?
- Diabetes Prevention Program and Breastfeeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 31 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant
- In second trimester or early third trimester
- BMI >/= 25 and < 35
- At least 18 years old or older
- Able to read and understand English
- Able to learn and use a video platform
Who cannot join
- Complications related to pregnancy that require emergency care
- Thyroid disease
- Multiple gestation
- Substance abuse within last 3 years
- Assisted reproductive technology (ART)-related pregnancy
- Current smoker
Show all 15Show fewer
- Prior bariatric surgery
- In weight-loss program within 3 months of conception
- BMI >/= 35
- Unable to attend intervention/ follow-up visits
- Unwilling to self-monitor data collection
- Unable to complete intervention
- Presence of any condition that limits walking
- Presence of any condition that limits following diet recommendations
- Pregnancies complicated with fetuses diagnosed with lethal malformations/conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Via Christi Maternal Fetal Medicine Clinic
Wichita, Kansas, 67218
About this study
Official title: Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0
The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.
Read the detailed description
This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention-based program (DPP) in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum. The trial will have two study arms: DPP + breastfeeding (Tx1) and Usual Care (Tx2).
Aim 1: Quantify interest in use of the DPP-lactation mobile health (mHealth) application among target population. To accomplish this, we will: (1) measure research engagement including rates of screening, recruitment, and retention among users, especially rural and racially/ethnically diverse women; (2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence via tracking/measuring use of the mHealth app.
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among target population. To accomplish this, we will measure pre-pregnancy weight, weight at study entry, weight immediately prior to and after delivery, and weight at specific postpartum time points. Lactation and infant feeding practices will be measured at similar postpartum time points.
- Conditions
- Overweight or Obesity, Pregnancy
- Being tested
- Diabetes Prevention Program, Breastfeeding, Usual Care
- Keywords
- diabetes prevention, breastfeeding, lactation support, prediabetes
- Medical subject headings
- Overweight, Obesity, Breast Feeding, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
The intervention will be administered by professionally trained, certified health coaches. Phase I consists of four 1-hour DPP-based sessions to be completed during pregnancy. Each session will be pre-recorded and archived on a secure, private mHealth application. Participants will be asked to complete each session on their own time. A health coach will follow up weekly via phone to check on progress and will work with the participant 1-on-1, if needed. Phase I will be completed by week 36 of pregnancy. Prior to delivery, participants are invited to a virtual focus group about their experiences.
Phase II consists of two 1-hour DPP-based sessions to be completed after delivery. Each session will be pre-recorded and archived on the same mHealth application. Participants will begin Phase II within 1 week of delivery with the same health coach. Phase II will be completed by week 12 postpartum. Upon completion, participants are invited to a virtual focus group about their experiences.
BreastfeedingBehavioural
Phase I also consists of six (6) breastfeeding videos that are pre-recorded into 15-20 minute sessions and will be available on the mHealth application. Participants will have access to the first 2 sessions by week 28 of pregnancy and need to complete the remaining 4 sessions by week 36 of pregnancy. Each session is taught by an International Board Certified Lactation Consultant (IBCLC).
Participants will receive 1-on-1 lactation support by the same DPP health coach. The health coach is a professionally trained Certified Breastfeeding Specialist (CBS). She will assist participants with any questions related to lactation. If the health coach is unable to help with a specific issue, she will contact the IBCLC-of-record, who will provide assistance to the health coach only. If the health coach or IBCLC deems additional care necessary, the participant will be referred to their primary care physician. The IBCLC will not have direct contact with the study participants.
Usual CareBehavioural
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| DPP + Breastfeeding (Tx1) | Active comparator | Patients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum. Receives: Behavioral: Diabetes Prevention Program; Behavioral: Breastfeeding; Behavioral: Usual Care |
| Usual Care | Placebo comparator | Usual care is described as obstetrical care that pregnant women with normal BMI receive and that is provided by their provider. There will not be any antepartum education or 1-on-1 health coaching. Postpartum education will only include usual care in-hospital lactation support. There will not be any other education nor 1-on-1 support. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight
The study team will measure maternal weight to calculate maternal BMI and to allow for meaningful comparisons of weight change among study arms.
Measured: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
Maternal body mass index (BMI)
Body mass index (BMI) is a measure of body fat based on height and weight. The study team will measure BMI and to allow for meaningful comparisons of weight change among study arms.
Measured: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
Initiation of Lactation
The study team will assess whether (yes/no) lactation was initiated at birth.
Measured: At delivery.
Duration of Lactation
The study team will measure duration of maternal ability to breastfeed at specific timepoints.
Measured: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
Type of Infant Feeding
The study team will measure "exclusive" lactation (human milk only) versus "any" lactation (predominant human milk with formula or solid food supplementation) at specific timepoints.
Measured: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
Secondary outcomes (5)
Recruitment Rate
To assess recruitment rate, the study team will track the percent (%) of potential participants contacted versus the percent (%) of participants enrolled in the study.
Measured: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Retention Rate
To assess retention rate, the study team will track the percent (%) of participants who complete the intervention.
Measured: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Research Engagement
Participants who complete each phase of the program will be invited to participate in focus groups to discuss program experiences.
Measured: After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.
Mobile Application Usage
To assess intervention uptake, the study team will track the amount of time spent on each session on the mobile app.
Measured: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Health Coach Interaction
To assess intervention uptake, the study team will track the amount of time spent with the health coach.
Measured: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start30 Apr 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ascension Health, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Lisette Jacobson, University of Kansas Medical Center
- Investigators
- Lisette Jacobson, PhD, MPA, MA, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372860
- Sponsor's protocol ID
- RKS2018350
- Other IDs
- 3P20GM144269-02S2
- Status last verified
- Dec 2025
- First submitted
- 4 Apr 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0
- ClinicalTrials.gov ID
- NCT06372860
- Acronym / sponsor ID
- RKS2018350
- Conditions
- Overweight or Obesity, Pregnancy
- Keywords
- diabetes prevention, breastfeeding, lactation support, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Ascension Health, National Institute of General Medical Sciences (NIGMS)
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 Apr 2024 (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 investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.
Detailed description
This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention-based program (DPP) in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum. The trial will have two study arms: DPP + breastfeeding (Tx1) and Usual Care (Tx2).
Aim 1: Quantify interest in use of the DPP-lactation mobile health (mHealth) application among target population. To accomplish this, we will: (1) measure research engagement including rates of screening, recruitment, and retention among users, especially rural and racially/ethnically diverse women; (2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence via tracking/measuring use of the mHealth app.
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among target population. To accomplish this, we will measure pre-pregnancy weight, weight at study entry, weight immediately prior to and after delivery, and weight at specific postpartum time points. Lactation and infant feeding practices will be measured at similar postpartum time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP + Breastfeeding (Tx1) | Active comparator | Behavioral: Diabetes Prevention Program, Behavioral: Breastfeeding, Behavioral: Usual CarePatients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum. |
| Usual Care | Placebo comparator | Behavioral: Usual CareUsual care is described as obstetrical care that pregnant women with normal BMI receive and that is provided by their provider. There will not be any antepartum education or 1-on-1 health coaching. Postpartum education will only include usual care in-hospital lactation support. There will not be any other education nor 1-on-1 support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant
- In second trimester or early third trimester
- BMI >/= 25 and < 35
- At least 18 years old or older
- Able to read and understand English
Key exclusion criteria (15 listed)
- Complications related to pregnancy that require emergency care
- Thyroid disease
- Multiple gestation
- Substance abuse within last 3 years
- Assisted reproductive technology (ART)-related pregnancy
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 |
|---|---|---|
| Diabetes Prevention ProgramThe intervention will be administered by professionally trained, certified health coaches. Phase I consists of four 1-hour DPP-based sessions to be completed during pregnancy. Each session will be pre-recorded and archived on a secure, private mHealth application. Participants will be asked to complete each session on their own time. A health coach will follow up weekly via phone to check on progress and will work with the participant 1-on-1, if needed. Phase I will be completed by week 36 of pregnancy. Prior to delivery, participants are invited to a virtual focus group about their experiences. Phase II consists of two 1-hour DPP-based sessions to be completed after delivery. Each session will be pre-recorded and archived on the same mHealth application. Participants will begin Phase II within 1 week of delivery with the same health coach. Phase II will be completed by week 12 postpartum. Upon completion, participants are invited to a virtual focus group about their experiences. | Behavioural | DPP + Breastfeeding (Tx1) |
| BreastfeedingPhase I also consists of six (6) breastfeeding videos that are pre-recorded into 15-20 minute sessions and will be available on the mHealth application. Participants will have access to the first 2 sessions by week 28 of pregnancy and need to complete the remaining 4 sessions by week 36 of pregnancy. Each session is taught by an International Board Certified Lactation Consultant (IBCLC). Participants will receive 1-on-1 lactation support by the same DPP health coach. The health coach is a professionally trained Certified Breastfeeding Specialist (CBS). She will assist participants with any questions related to lactation. If the health coach is unable to help with a specific issue, she will contact the IBCLC-of-record, who will provide assistance to the health coach only. If the health coach or IBCLC deems additional care necessary, the participant will be referred to their primary care physician. The IBCLC will not have direct contact with the study participants. | Behavioural | DPP + Breastfeeding (Tx1) |
| Usual CareParticipants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital. | Behavioural | DPP + Breastfeeding (Tx1), Usual Care |
Primary outcome
Maternal weight
Time frame: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
The study team will measure maternal weight to calculate maternal BMI and to allow for meaningful comparisons of weight change among study arms.
Maternal body mass index (BMI)
Time frame: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
Body mass index (BMI) is a measure of body fat based on height and weight. The study team will measure BMI and to allow for meaningful comparisons of weight change among study arms.
Initiation of Lactation
Time frame: At delivery.
The study team will assess whether (yes/no) lactation was initiated at birth.
Duration of Lactation
Time frame: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
The study team will measure duration of maternal ability to breastfeed at specific timepoints.
Type of Infant Feeding
Time frame: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
The study team will measure "exclusive" lactation (human milk only) versus "any" lactation (predominant human milk with formula or solid food supplementation) at specific timepoints.
5 secondary outcomes
Recruitment Rate
Time frame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Retention Rate
Time frame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Research Engagement
Time frame: After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.
Mobile Application Usage
Time frame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
Health Coach Interaction
Time frame: This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.
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 18 Dec 2025.
Related trials for Overweight or Obesity
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
Lisette Jacobson, PhD, MPA, MA principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program and Breastfeeding in people with Overweight or Obesity and Pregnancy, run by University of Kansas Medical Center 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 6 inclusion and 15 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 18 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Maternal weight (time frame: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.