Diabetes Prevention Program Feasibility Study of Breastfeeding
2 other identifiers
interventional
35
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Sep 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedStudy Start
First participant enrolled
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedResults Posted
Study results publicly available
January 13, 2025
CompletedJanuary 13, 2025
January 1, 2025
1.6 years
June 12, 2019
November 27, 2024
January 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
At delivery through 6 months postpartum
Secondary Outcomes (4)
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
At baseline and at 6 months postpartum
Kaiser Physical Activity Survey (KPAS, Weighted Total)
At baseline and at 6 months postpartum
Fruit & Vegetable Intake Screener (EATS)
At baseline and at 6 months postpartum
Edinburgh Postnatal Depression Scale (EPDS)
Postpartum
Study Arms (3)
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
ACTIVE COMPARATORPatients 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 COMPARATORPatients 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 COMPARATORPatients 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.
Interventions
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.
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.
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy complications that require emergency care
- Thyroid disease
- Multiple gestation
- Substance abuse within last 3 years
- ART (Assisted Reproductive Technology) pregnancy
- Current smoker
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kearny County Hospital
Lakin, Kansas, 67860, United States
Via Christi Maternal Fetal Medicine Clinic
Wichita, Kansas, 67218, United States
Related Publications (1)
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.
PMID: 37461383DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisette T. Jacobson, Ph.D., MPA, M.A., Associate Professor, Obstetrics and Gynecology
- Organization
- University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Preventive Medicine
Study Record Dates
First Submitted
June 12, 2019
First Posted
July 16, 2019
Study Start
September 18, 2019
Primary Completion
May 7, 2021
Study Completion
May 31, 2021
Last Updated
January 13, 2025
Results First Posted
January 13, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share