Diabetes Prevention Program Feasibility Study of Breastfeeding - Electronic Monitoring of Mom's Schedule 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Maternal weight
研究概览
简要总结
The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application.
详细描述
This study is a randomized controlled trial designed to determine the feasibility and efficacy of a combined breastfeeding, diabetes prevention-based program (DPP) in a cohort of overweight or obese women to be followed during pregnancy through 3 months postpartum. The trial will have two study arms: DPP + breastfeeding (Tx1) and Usual Care (Tx2).
Aim 1: Quantify interest in use of the DPP-lactation mobile health (mHealth) application among target population. To accomplish this, we will: (1) measure research engagement including rates of screening, recruitment, and retention among users, especially rural and racially/ethnically diverse women; (2) assess barriers/facilitators to enrollment/retention through surveys and semi-structured in-depth interviews or focus groups; and (3) evaluate intervention uptake, delivery, and adherence via tracking/measuring use of the mHealth app.
Aim 2: Measure weight loss and duration of lactation through 3 months postpartum among target population. To accomplish this, we will measure pre-pregnancy weight, weight at study entry, weight immediately prior to and after delivery, and weight at specific postpartum time points. Lactation and infant feeding practices will be measured at similar postpartum time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In second trimester or early third trimester
- •BMI >/= 25 and < 35
- •At least 18 years old or older
- •Able to read and understand English
- •Able to learn and use a video platform
排除标准
- •Complications related to pregnancy that require emergency care
- •Thyroid disease
- •Multiple gestation
- •Substance abuse within last 3 years
- •Assisted reproductive technology (ART)-related 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
研究组 & 干预措施
DPP + Breastfeeding (Tx1)
Patients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum.
干预措施: Breastfeeding (Behavioral)
DPP + Breastfeeding (Tx1)
Patients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum.
干预措施: Diabetes Prevention Program (Behavioral)
DPP + Breastfeeding (Tx1)
Patients randomized to Tx1 will receive education in the Diabetes Prevention Program (DPP) and intensive breastfeeding education and support. Ante- and postpartum education includes access to the mHealth app and individualized 1-on-1 health coaching. Phase I is delivered antepartum and includes: four (4) 1-hour DPP-based educational sessions and six (6) 20-minute educational videos on lactation. Phase II is delivered postpartum and includes: in-hospital lactation support and two (2) 1-hour DPP-based educational sessions. Participants will continue to receive individualized 1-on-1 health coaching through 3 months postpartum.
干预措施: Usual Care (Behavioral)
Usual Care
Usual care is described as obstetrical care that pregnant women with normal BMI receive and that is provided by their provider. There will not be any antepartum education or 1-on-1 health coaching. Postpartum education will only include usual care in-hospital lactation support. There will not be any other education nor 1-on-1 support.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Maternal weight
时间窗: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
The study team will measure maternal weight to calculate maternal BMI and to allow for meaningful comparisons of weight change among study arms.
Initiation of Lactation
时间窗: At delivery.
The study team will assess whether (yes/no) lactation was initiated at birth.
Duration of Lactation
时间窗: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
The study team will measure duration of maternal ability to breastfeed at specific timepoints.
Maternal body mass index (BMI)
时间窗: At baseline; at week 30, 32, and 34 of pregnancy; and at day 3, 10, week 3, 6, month 2 and month 3 postpartum.
Body mass index (BMI) is a measure of body fat based on height and weight. The study team will measure BMI and to allow for meaningful comparisons of weight change among study arms.
Type of Infant Feeding
时间窗: At delivery, discharge, at day 7, week 3, 6, month 1, 2, and 3 postpartum.
The study team will measure "exclusive" lactation (human milk only) versus "any" lactation (predominant human milk with formula or solid food supplementation) at specific timepoints.
次要结局
- Recruitment Rate(This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.)
- Health Coach Interaction(This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.)
- Research Engagement(After week 36 of pregnancy but prior to delivery, and after month 3 postpartum.)
- Retention Rate(This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.)
- Mobile Application Usage(This will occur between day 1 of first participant enrollment through study completion, roughly 1-1.5 years.)
研究者
Lisette Jacobson
Associate Professor, Population Health
University of Kansas Medical Center