Diabetes Prevention Program Feasibility Study of Breastfeeding

University of Kansas

Status: Completed

Conditions: Overweight and Obesity; Pregnancy

Treatments: Behavioral: Usual Care; Behavioral: Breastfeeding Education; Behavioral: Diabetes Prevention Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04021602

KU-VC1752

1K01DK113048-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups, including a placebo group

Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Diabetes Prevention Program

Behavioral: Usual Care

Behavioral: Breastfeeding Education

Intervention 2 (Tx2) - DPP Only + Usual Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Diabetes Prevention Program

Behavioral: Usual Care

Intervention 3 (Tx3) - Usual Care Only

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care