Diabetes Prevention Program Feasibility Study of Breastfeeding

January 7, 2025 updated by: Lisette Jacobson, University of Kansas Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lakin, Kansas, United States, 67860
        • Kearny County Hospital
      • Wichita, Kansas, United States, 67218
        • Via Christi Maternal Fetal Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 6 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 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.
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 6 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and at delivery through 6 months postpartum
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.
At baseline and at 6 months postpartum
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.
At baseline, at delivery, 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.
At delivery through 6 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and at 6 months postpartum
Kaiser Physical Activity Survey (KPAS, Weighted Total)
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 (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.
At baseline and at 6 months postpartum
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.). Frequency is scored from 0.0-5.0, with 0 meaning never, and 5.0 meaning 5 or more servings per day.
At baseline and at 6 months postpartum
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. 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.
Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ascension Via Christi Hospitals Wichita, Inc.
Kearny County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KU-VC1752
  • 1K01DK113048-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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