Diabetes Prevention Program Feasibility Study of Breastfeeding

Pregnancy Clinical Trial

Official title:

Diabetes Prevention Program Feasibility Study of Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021602
• Other study ID #: KU-VC1752
• Secondary ID: 1K01DK113048-01A
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Pregnancy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Kearny County Hospital	Lakin	Kansas
United States	Via Christi Maternal Fetal Medicine Clinic	Wichita	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Ascension Via Christi Hospitals Wichita, Inc., Kearny County Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Duration of Breastfeeding	The study team will measure duration of breastfeeding from delivery through 6 months postpartum.	At delivery through 6 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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