PregnancyNCT04021602
Diabetes Prevention Program Feasibility Study of Breastfeeding
A study testing Diabetes Prevention Program and Breastfeeding Education in people with Pregnancy and Overweight and Obesity, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Overweight and Obesity
- What is being tested?
- Diabetes Prevention Program and Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, 1st trimester or early 2nd trimester
- Interested in breastfeeding
- BMI >/= 25 and <35
- Able to read and understand English
- Able to learn and use Facebook
- Able to learn and use Skype, FaceTime or Zoom for virtual meetings
- Must have a cell phone
Who cannot join
- Pregnancy complications that require emergency care
- Thyroid disease
- Multiple gestation
- Substance abuse within last 3 years
- ART (Assisted Reproductive Technology) 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
2 sites in 1 country.
United States2 sites
Kearny County Hospital
Lakin, Kansas, 67860
Via Christi Maternal Fetal Medicine Clinic
Wichita, Kansas, 67218
About this study
The purpose of this study is to learn about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.
Read the detailed description
This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI >/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI >/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI >/= 25.
- Conditions
- Pregnancy, Overweight and Obesity
- Being tested
- Diabetes Prevention Program, Breastfeeding Education, Usual Care
- Keywords
- diabetes prevention program, breastfeeding, 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
Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.
Breastfeeding EducationBehavioural
Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
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 |
|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Active comparator | Patients randomized to Tx1 will receive education in both the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions (core curriculum), one 2-hour breastfeeding session, and participation in a professional peer support group. The 2-hour breastfeeding session is pre-recorded into four (4) 30-minute sessions and archived on a secure, private Facebook group. Participants will have access to all four breastfeeding sessions by week 24 of pregnancy and they need to complete all sessions by week 30 of pregnancy. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support (at day 3, day 10, week 3 and week 6), followed by 6 DPP sessions (post-core curriculum). Receives: Behavioral: Diabetes Prevention Program; Behavioral: Breastfeeding Education; Behavioral: Usual Care |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Active comparator | Patients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions (core curriculum). At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions (post-core curriculum). Receives: Behavioral: Diabetes Prevention Program; Behavioral: Usual Care |
| Intervention 3 (Tx3) - Usual Care Only | Placebo comparator | Patients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Measured: At baseline and at delivery through 6 months postpartum
Change in HbA1c
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Measured: At baseline and at 6 months postpartum
Change in Arterial Blood Pressure
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Measured: At baseline, at delivery, and at 6 months postpartum
Duration of Breastfeeding
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Measured: At delivery through 6 months postpartum
Secondary outcomes (4)
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
To assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase "I can always" and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Measured: At baseline and at 6 months postpartum
Kaiser Physical Activity Survey (KPAS, Weighted Total)
To assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for "never" or "none" to 5 for "always" or "more than once a week" in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index*0.25 + occupational index*0.25 + active living index*0.25 + sports/exercise index*0.25) * 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level.
Measured: At baseline and at 6 months postpartum
Fruit & Vegetable Intake Screener (EATS)
To assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: <3/4cup, 3/4 to 1 1/4 cup, >2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.
Measured: At baseline and at 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS)
To assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.
Measured: Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start18 Sep 2019
- Primary completion7 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ascension Health, Kearny County Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Lisette Jacobson, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021602
- Sponsor's protocol ID
- KU-VC1752
- Other IDs
- 1K01DK113048-01A1
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2019
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobson LT, Bakhache N, Dowling J, Okut H, Zackula R, Robbins DC, Stern JE, Grainger DA, Befort C. Electronic Monitoring of Mom's Schedule (eMOMSTM): A Qualitative Study of Experiences in a Lifestyle Change Program with Lactation Support. Am J Health Promot. 2023 Sep;37(7):953-963. doi: 10.1177/08901171231189540. Epub 2023 Jul 18.
PubMed 37461383
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention Program Feasibility Study of Breastfeeding
- ClinicalTrials.gov ID
- NCT04021602
- Acronym / sponsor ID
- KU-VC1752
- Conditions
- Pregnancy, Overweight and Obesity
- Keywords
- diabetes prevention program, breastfeeding, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Ascension Health, Kearny County Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 13 Jan 2025
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 about the impact of the Diabetes Prevention Program (DPP) coupled with intensive breastfeeding support to help overweight or obese pregnant women lose weight postpartum, improve their blood sugars and blood pressure, and increase duration of breastfeeding their infant.
Detailed description
This pilot randomized controlled trial seeks to determine the feasibility and efficacy of a combined breastfeeding, DPP-based program in a cohort of overweight/obese women to be followed during pregnancy through 6 months postpartum. The pilot trial will have three study arms: DPP + breastfeeding (Tx1), DPP only (Tx2), and usual care (Tx3). Specific aims are: 1) To test the efficacy of Tx1 to improve 6-month postpartum weight loss among women with a BMI >/= 25. 2) To test the efficacy of Tx1 to improve 6-month postpartum mean blood glucose (HbA1c) and mean arterial blood pressure among women with a BMI >/= 25. 3) To test the efficacy of Tx1 to increase any breastfeeding through 6 months postpartum among women with a BMI >/= 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care | Active comparator | Behavioral: Diabetes Prevention Program, Behavioral: Breastfeeding Education, Behavioral: Usual CarePatients randomized to Tx1 will receive education in both the Diabetes Prevention Program (DPP) and in Breastfeeding. At baseline, this includes 16 DPP sessions (core curriculum), one 2-hour breastfeeding session, and participation in a professional peer support group. The 2-hour breastfeeding session is pre-recorded into four (4) 30-minute sessions and archived on a secure, private Facebook group. Participants will have access to all four breastfeeding sessions by week 24 of pregnancy and they need to complete all sessions by week 30 of pregnancy. At delivery, the patient will receive usual lactation support in the hospital, additional breastfeeding assessment and support (at day 3, day 10, week 3 and week 6), followed by 6 DPP sessions (post-core curriculum). |
| Intervention 2 (Tx2) - DPP Only + Usual Care | Active comparator | Behavioral: Diabetes Prevention Program, Behavioral: Usual CarePatients randomized to Tx2 will receive education in only the Diabetes Prevention Program. At baseline, this includes 16 DPP sessions (core curriculum). At delivery, the patient will receive usual lactation support in the hospital, followed by 6 DPP sessions (post-core curriculum). |
| Intervention 3 (Tx3) - Usual Care Only | Placebo comparator | Behavioral: Usual CarePatients randomized to Tx3 will receive only usual standard of care. At baseline, the patient will receive only regular prenatal care provided by their physician. At delivery, the patient will receive standard of care breastfeeding support provided by the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant, 1st trimester or early 2nd trimester
- Interested in breastfeeding
- BMI >/= 25 and <35
- Able to read and understand English
- Able to learn and use Facebook
Key exclusion criteria (15 listed)
- Pregnancy complications that require emergency care
- Thyroid disease
- Multiple gestation
- Substance abuse within last 3 years
- ART (Assisted Reproductive Technology) 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 ProgramPhase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy. | Behavioural | Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care, Intervention 2 (Tx2) - DPP Only + Usual Care |
| Breastfeeding EducationParticipants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum. | Behavioural | Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care |
| 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 | Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care, Intervention 2 (Tx2) - DPP Only + Usual Care, Intervention 3 (Tx3) - Usual Care Only |
Primary outcome
Change in Weight
Time frame: At baseline and at delivery through 6 months postpartum
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Change in HbA1c
Time frame: At baseline and at 6 months postpartum
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Change in Arterial Blood Pressure
Time frame: At baseline, at delivery, and at 6 months postpartum
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Duration of Breastfeeding
Time frame: At delivery through 6 months postpartum
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
4 secondary outcomes
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
Time frame: At baseline and at 6 months postpartum
Kaiser Physical Activity Survey (KPAS, Weighted Total)
Time frame: At baseline and at 6 months postpartum
Fruit & Vegetable Intake Screener (EATS)
Time frame: At baseline and at 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37461383Jacobson LT, Bakhache N, Dowling J, Okut H, Zackula R, Robbins DC, Stern JE, Grainger DA, Befort C. Electronic Monitoring of Mom's Schedule (eMOMSTM): A Qualitative Study of Experiences in a Lifestyle Change Program with Lactation Support. Am J Health Promot. 2023 Sep;37(7):953-963. doi: 10.1177/08901171231189540. Epub 2023 Jul 18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Education in people with Pregnancy and Overweight and Obesity, run by University of Kansas Medical Center at 2 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 7 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Weight (time frame: At baseline and at delivery through 6 months postpartum). The study lists 4 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 NCT04021602, 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 13 Jan 2025.