search
Back to results

Diabetes Prevention Program Feasibility Study of Breastfeeding

Primary Purpose

Pregnancy, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program
Breastfeeding Education
Usual Care
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring diabetes prevention program, breastfeeding, prediabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Kearny County Hospital
  • Via Christi Maternal Fetal Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

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

Intervention 2 (Tx2) - DPP Only + Usual Care

Intervention 3 (Tx3) - Usual Care Only

Arm 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).

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).

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.

Outcomes

Primary Outcome Measures

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.
Change in HbA1c
The study team will measure mean blood glucose 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.
Duration of Breastfeeding
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Supplementation of Formula
The study team will record instances of supplementation with formula from 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.

Secondary Outcome Measures

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.
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.
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.
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.).
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.
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.
Baby's Weight
The study team will record the baby's weight at different time points from delivery through 6 months postpartum.
Baby's Height
The study team will record the baby's height at different time points from delivery through 6 months postpartum.

Full Information

First Posted
June 12, 2019
Last Updated
September 27, 2021
Sponsor
University of Kansas Medical Center
Collaborators
Ascension Via Christi Hospitals Wichita, Inc., Kearny County Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04021602
Brief Title
Diabetes Prevention Program Feasibility Study of Breastfeeding
Official Title
Diabetes Prevention Program Feasibility Study of Breastfeeding
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Ascension Via Christi Hospitals Wichita, Inc., Kearny County Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Overweight and Obesity
Keywords
diabetes prevention program, breastfeeding, prediabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1 (Tx1) - DPP + Breastfeeding + Usual Care
Arm Type
Active Comparator
Arm 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).
Arm Title
Intervention 2 (Tx2) - DPP Only + Usual Care
Arm Type
Active Comparator
Arm 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).
Arm Title
Intervention 3 (Tx3) - Usual Care Only
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breastfeeding Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
Primary Outcome Measure Information:
Title
Change in Weight
Description
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.
Time Frame
At baseline and at delivery through 6 months postpartum
Title
Change in HbA1c
Description
The study team will measure mean blood glucose at baseline and at 6 months postpartum.
Time Frame
At baseline and at 6 months postpartum
Title
Change in Arterial Blood Pressure
Description
The study team will measure mean arterial blood pressure at baseline and at 6 months postpartum.
Time Frame
At baseline, at delivery, and at 6 months postpartum
Title
Duration of Breastfeeding
Description
The study team will measure duration of breastfeeding from delivery through 6 months postpartum.
Time Frame
At delivery through 6 months postpartum
Title
Supplementation of Formula
Description
The study team will record instances of supplementation with formula from delivery through 6 months postpartum.
Time Frame
At delivery through 6 months postpartum
Title
Introduction of Solid Food
Description
The study team will record time of introduction of solid food from delivery through 6 months postpartum.
Time Frame
At delivery through 6 months postpartum
Secondary Outcome Measure Information:
Title
Breastfeeding Knowledge Assessment, Sociodemographic Characteristics, and Health Status (survey)
Description
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.
Time Frame
At baseline and at 6 months postpartum
Title
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, survey)
Description
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.
Time Frame
At baseline and at 6 months postpartum
Title
Kaiser Physical Activity Survey (KPAS)
Description
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.
Time Frame
At baseline and at 6 months postpartum
Title
Fruit & Vegetable Intake Screener (EATS)
Description
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.).
Time Frame
At baseline and at 6 months postpartum
Title
Selected Items from the Dietary Screener Questionnaire (NHANES 2009-10)
Description
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.
Time Frame
At baseline and at 6 months postpartum
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
Postpartum
Title
Baby's Weight
Description
The study team will record the baby's weight at different time points from delivery through 6 months postpartum.
Time Frame
At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6
Title
Baby's Height
Description
The study team will record the baby's height at different time points from delivery through 6 months postpartum.
Time Frame
At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Kearny County Hospital
City
Lakin
State/Province
Kansas
ZIP/Postal Code
67860
Country
United States
Facility Name
Via Christi Maternal Fetal Medicine Clinic
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diabetes Prevention Program Feasibility Study of Breastfeeding

We'll reach out to this number within 24 hrs