Diabetes Prevention Program Feasibility Study of Breastfeeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetes Prevention Program Feasibility Study of Breastfeeding

Conditions
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Pregnancy, Overweight and Obesity

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program
* Behavioral: Breastfeeding Education
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care<br>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). | Behavioral: Diabetes Prevention Program<br>* Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.<br>Behavioral: Breastfeeding Education<br>* Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.<br>Behavioral: Usual Care<br>* Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.<br>|
| Active Comparator: Intervention 2 (Tx2) - DPP Only + Usual Care<br>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). | Behavioral: Diabetes Prevention Program<br>* Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.<br>Behavioral: Usual Care<br>* Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.<br>|
| Placebo Comparator: Intervention 3 (Tx3) - Usual Care Only<br>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. | Behavioral: Usual Care<br>* Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | 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. | At baseline and at delivery through 6 months postpartum | 
| Change in HbA1c | The study team will measure mean blood glucose at baseline and at 6 months postpartum. | At baseline and at 6 months postpartum | 
| Change in Arterial Blood Pressure | The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum. | At baseline, at delivery, and at 6 months postpartum | 
| Duration of Breastfeeding | The study team will measure duration of breastfeeding from delivery through 6 months postpartum. | At delivery through 6 months postpartum | 
| Supplementation of Formula | The study team will record instances of supplementation with formula from delivery through 6 months postpartum. | At delivery through 6 months postpartum | 
| Introduction of Solid Food | The study team will record time of introduction of solid food from delivery through 6 months postpartum. | At delivery through 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding Knowledge Assessment, Sociodemographic Characteristics, and Health Status (survey) | The purpose of this survey is to learn more about what pregnant women know about breastfeeding, to asses sociodemographic characteristics, and to assess health status. The survey consists of 58 items, which are multiple choice. Many include a Likert-type scale, ranging from strongly agree to strongly disagree (i.e.: Breast milk changes as my baby grows.) Some questions are open-ended (i.e.: Please share with us what other pre- and post-birth healthcare services including breastfeeding you would like to see offered or any additional comments you may have.) This survey is not scored, but will be used to assess change in breastfeeding knowledge pre- and post- intervention. | At baseline and at 6 months postpartum | 
| Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, survey) | 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. | At baseline and at 6 months postpartum | 
| Kaiser Physical Activity Survey (KPAS) | 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. 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. | At baseline and at 6 months postpartum | 
| Fruit & Vegetable Intake Screener (EATS) | 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.). | At baseline and at 6 months postpartum | 
| Selected Items from the Dietary Screener Questionnaire (NHANES 2009-10) | To assess intake of fiber, added sugars, dairy, calcium and meat before and after pregnancy. Six items were selected from this survey. Each question asks over the last month how often a particular item was consumed. Answers range from never to 2 or more times per day. | At baseline and at 6 months postpartum | 
| Edinburgh Postnatal Depression Scale (EPDS) | 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. Higher score indicates risk of depression. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up. | Postpartum | 
| Baby's Weight | The study team will record the baby's weight at different time points from delivery through 6 months postpartum. | At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6 | 
| Baby's Height | The study team will record the baby's height at different time points from delivery through 6 months postpartum. | At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes prevention program, breastfeeding, prediabetes