CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Diabetes Prevention Program +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04021602
NCT04021602N/ACompleted

Diabetes Prevention Program Feasibility Study of Breastfeeding

University of Kansas Medical Center·interventional·Posted Jul 16, 2019·Updated Jan 13, 2025

In Brief

A clinical study evaluating Diabetes Prevention Program, Breastfeeding Education, and 1 other intervention for Pregnancy and Overweight and Obesity. Completed, enrolled 35 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 16, 2019
Enrollment StartSep 18, 2019
Primary CompletionMay 7, 2021
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.0 years ago

Interventions

Diabetes Prevention Programbehavioral

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 Educationbehavioral

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 Carebehavioral

Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.