Clinical trial NCT04021602: Diabetes Prevention Program Feasibility Study of Breastfeeding
Official title: Diabetes Prevention Program Feasibility Study of Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Overweight and Obesity
Keywords: diabetes prevention program
breastfeeding
prediabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Ascension Via Christi Hospitals Wichita, Inc.
name: Kearny County Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-07-16
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Weight
timeFrame: At baseline and at delivery through 6 months postpartum
measure: Change in HbA1c
timeFrame: At baseline and at 6 months postpartum
measure: Change in Arterial Blood Pressure
timeFrame: At baseline, at delivery, and at 6 months postpartum
measure: Duration of Breastfeeding
timeFrame: At delivery through 6 months postpartum
Secondary outcomes:
measure: Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)
timeFrame: At baseline and at 6 months postpartum
measure: Kaiser Physical Activity Survey (KPAS, Weighted Total)
timeFrame: At baseline and at 6 months postpartum
measure: Fruit & Vegetable Intake Screener (EATS)
timeFrame: At baseline and at 6 months postpartum
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Postpartum
Other outcomes:
Locations:
city: Lakin
country: United States
facility: Kearny County Hospital
state: Kansas
city: Wichita
country: United States
facility: Via Christi Maternal Fetal Medicine Clinic
state: Kansas
Study officials:
References: