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Diabetes Prevention Program Feasibility Study of Breastfeeding

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ClinicalTrials.gov Identifier: NCT04021602
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Ascension Via Christi St. Joseph
Kearny County Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lisette Jacobson, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Overweight and Obesity Behavioral: Diabetes Prevention Program Behavioral: Breastfeeding Education Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Prevention Program Feasibility Study of Breastfeeding
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Active Comparator: 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 15 DPP sessions (post-core curriculum).
Behavioral: Diabetes Prevention Program
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 15 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.

Behavioral: Breastfeeding Education
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.

Behavioral: Usual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.

Active Comparator: 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 15 DPP sessions (post-core curriculum).
Behavioral: Diabetes Prevention Program
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 15 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.

Behavioral: Usual Care
Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.

Placebo Comparator: 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.
Behavioral: Usual Care
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 Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Supplementation of Formula [ Time Frame: At delivery through 6 months postpartum ]
    The study team will record instances of supplementation with formula from delivery through 6 months postpartum.

  6. Introduction of Solid Food [ Time Frame: At delivery through 6 months postpartum ]
    The study team will record time of introduction of solid food from delivery through 6 months postpartum.


Secondary Outcome Measures :
  1. Breastfeeding Knowledge Assessment, Sociodemographic Characteristics, and Health Status (survey) [ Time Frame: At baseline and at 6 months postpartum ]
    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.

  2. Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF, survey) [ Time Frame: 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.

  3. Kaiser Physical Activity Survey (KPAS) [ Time Frame: 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. 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.


  4. Fruit & Vegetable Intake Screener (EATS) [ Time Frame: 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.).

  5. Selected Items from the Dietary Screener Questionnaire (NHANES 2009-10) [ Time Frame: At baseline and at 6 months postpartum ]
    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.

  6. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 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. Higher score indicates risk of depression. Participants with a score of 10 or greater will be referred to their healthcare provider for follow up.

  7. Baby's Weight [ Time Frame: At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6 ]
    The study team will record the baby's weight at different time points from delivery through 6 months postpartum.

  8. Baby's Height [ Time Frame: At delivery; Day 3, Day 10, Week 3, Week 6, Month 2, Month 3, Month 6 ]
    The study team will record the baby's height at different time points from delivery through 6 months postpartum.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021602


Contacts
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Contact: Meredith Lucas, RN, BSN 316-293-3467 mlucas4@kumc.edu
Contact: Lisette Jacobson, PhD, MPA, MA 316-293-3484 ljacobson@kumc.edu

Locations
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United States, Kansas
Kearny County Hospital Recruiting
Lakin, Kansas, United States, 67860
Contact: Meredith Lucas, RN, BSN         
Via Christi Maternal Fetal Medicine Clinic Recruiting
Wichita, Kansas, United States, 67218
Contact: Meredith Lucas, RN, BSN         
Sponsors and Collaborators
University of Kansas Medical Center
Ascension Via Christi St. Joseph
Kearny County Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Study Documents (Full-Text)

Documents provided by Lisette Jacobson, University of Kansas Medical Center:
Informed Consent Form  [PDF] March 25, 2019


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Responsible Party: Lisette Jacobson, Assistant Professor, Preventive Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04021602     History of Changes
Other Study ID Numbers: KU-VC1752
1K01DK113048-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisette Jacobson, University of Kansas Medical Center:
diabetes prevention program
breastfeeding
prediabetes
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms