N/A
Completed N=35
Diabetes Prevention Program Feasibility Study of Breastfeeding
Pregnancy · Overweight and Obesity
Source: ClinicalTrials.gov NCT04021602 ↗
Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Jan 2025
Primary outcomePrimary: Change in Weight — 7.5; 13.4; 18.2; -5.6 kgs
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
7.5; 13.4; 18.2; -5.6; -12.3; -11.2 | — |
| PRIMARY Change in HbA1c |
5.2; 5.2; 5.0; 5.3; 5.4; 5.1 | — |
| PRIMARY Change in Arterial Blood Pressure |
85.0; 90.7; 89.7; 92.7; 91.3; 90.8 | — |
| PRIMARY Duration of Breastfeeding |
4; 7; 6; 1; 4; 4 | — |
| SECONDARY Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey) |
33.0; 35.0; 41.0; 49.0; 52.0; 62.5 | — |
| SECONDARY Kaiser Physical Activity Survey (KPAS, Weighted Total) |
12.1; 10.1; 10.6; 12.4; 12.2; 10.6 | — |
| SECONDARY Fruit & Vegetable Intake Screener (EATS) |
1.6; 1.8; 1.9; 1.9; 1.8; 3.1 | — |
| SECONDARY Edinburgh Postnatal Depression Scale (EPDS) |
7; 6; 5; 7.5; 6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant, 1st trimester or early 2nd trimester
- Interested in breastfeeding
- BMI >/= 25 and /= 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
Data sourced from ClinicalTrials.gov (NCT04021602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.