Diabetes Prevention Program Feasibility Study of Breastfeeding
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Change in Arterial Blood Pressure
- Status
- Completed
- Last Updated
- last year
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.
Investigators
Lisette Jacobson
Assistant Professor, Preventive Medicine
University of Kansas Medical Center
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
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)