Diabetes Prevention Program Feasibility Study of Breastfeeding
NCT ID: NCT04021602
Last Updated: 2025-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2019-09-18
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
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).
Diabetes Prevention Program
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 Education
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 Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Intervention 2 (Tx2) - DPP Only + Usual Care
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).
Diabetes Prevention Program
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.
Usual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Intervention 3 (Tx3) - Usual Care Only
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.
Usual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Interventions
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Diabetes Prevention Program
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 Education
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 Care
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ascension Via Christi Hospitals Wichita, Inc.
OTHER
Kearny County Hospital
UNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Lisette Jacobson
Assistant Professor, Preventive Medicine
Locations
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Kearny County Hospital
Lakin, Kansas, United States
Via Christi Maternal Fetal Medicine Clinic
Wichita, Kansas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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KU-VC1752
Identifier Type: -
Identifier Source: org_study_id
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