Diabetes Prevention Program Feasibility Study of Breastfeeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Change in Arterial Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Diabetes Prevention Program (Behavioral)
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).
Intervention: Breastfeeding Education (Behavioral)
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).
Intervention: Usual Care (Behavioral)
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).
Intervention: Diabetes Prevention Program (Behavioral)
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).
Intervention: Usual Care (Behavioral)
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Change in Arterial Blood Pressure
Time Frame: At baseline, at delivery, and at 6 months postpartum
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Duration of Breastfeeding
Time Frame: At delivery through 6 months postpartum
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Change in Weight
Time Frame: At baseline and at delivery through 6 months postpartum
The study team will measure maternal weight at baseline, at delivery, and weekly during the postpartum period to allow for meaningful comparisons of weight change among study arms.
Change in HbA1c
Time Frame: At baseline and at 6 months postpartum
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Secondary Outcomes
- Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)(At baseline and at 6 months postpartum)
- Kaiser Physical Activity Survey (KPAS, Weighted Total)(At baseline and at 6 months postpartum)
- Fruit & Vegetable Intake Screener (EATS)(At baseline and at 6 months postpartum)
- Edinburgh Postnatal Depression Scale (EPDS)(Postpartum)
Investigators
Lisette Jacobson
Assistant Professor, Preventive Medicine
University of Kansas Medical Center