Diabetes Prevention Program Feasibility Study of Breastfeeding

Not Applicable

Completed

Conditions: Overweight and Obesity
Pregnancy

Interventions: Behavioral: Diabetes Prevention Program
Behavioral: Breastfeeding Education
Behavioral: Usual Care

Registration Number: NCT04021602

Lead Sponsor: University of Kansas Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care	Breastfeeding Education	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 1 (Tx1) - DPP + Breastfeeding + Usual Care	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 3 (Tx3) - Usual Care Only	Usual Care	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 1 (Tx1) - DPP + Breastfeeding + Usual Care	Diabetes Prevention Program	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 2 (Tx2) - DPP Only + Usual Care	Diabetes Prevention Program	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 2 (Tx2) - DPP Only + Usual Care	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).

Primary Outcome Measures

Name	Time	Method
Change in Arterial Blood Pressure	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	At delivery through 6 months postpartum	The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Change in Weight	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	At baseline and at 6 months postpartum	The study team will measure mean blood glucose at baseline and at 6 months postpartum.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, Survey)	At baseline and at 6 months postpartum	To assess levels of self-efficacy. Survey consists of 14 items. All items are preceded by the phrase "I can always" and are anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. All items are presented positively, and scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Kaiser Physical Activity Survey (KPAS, Weighted Total)	At baseline and at 6 months postpartum	To assess multiple domains of physical activity and total physical activity before and after pregnancy. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5 (scores ranged from 1 for "never" or "none" to 5 for "always" or "more than once a week" in each physical activity domain). Higher scores indicate greater overall activity levels. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index\0.25 + occupational index\0.25 + active living index\0.25 + sports/exercise index\0.25) \* 4. The total activity score has a potential range of 4 - 20 with a mean of 10.42 (SD=2.00). A higher total activity score indicates a greater activity level.
Fruit & Vegetable Intake Screener (EATS)	At baseline and at 6 months postpartum	To assess intake of fruits and vegetables before and after pregnancy. Survey consists of 10 items; with portion-size questions. Each question has two parts, asking over the last month how often a particular item was consumed (i.e.: never, 1-3x/mo, 1-2x/wk, etc.) and how much was usually consumed (i.e.: \<3/4cup, 3/4 to 1 1/4 cup, \>2 cups, etc.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.
Edinburgh Postnatal Depression Scale (EPDS)	Postpartum	To assess levels of depression during the postpartum period. Survey consists of 10 items. Questions 1, 2, \& 4 are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. Questions 3, 5--10 are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score is 30. A score of 10 or higher generally indicates a potential need for further assessment regarding possible depression, while scores above 12 or 13 may suggest a higher likelihood of depression requiring medical attention. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.

Trial Locations

Locations (2): Kearny County Hospital
🇺🇸
Lakin, Kansas, United States
Via Christi Maternal Fetal Medicine Clinic
🇺🇸
Wichita, Kansas, United States