Clinical trial NCT05394883: The SPROUT (Pilot) Project
Official title: The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Infant Development
Adherence, Treatment
Activity, Motor
Keywords: pregnancy
supervised exercise
home exercise
fitness
maternal health outcomes
neonatal outcomes
feasibility
adherence
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot investigation (feasibility) of a future larger study of interventional design with randomization. Participants in the pilot phase of the project will be randomized into one of three groups: supervised exercise, home exercise, or usual care.
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to study two different approaches to exercise during pregnancy that investigators believe will result in improved health for moms and babies. The investigators are trying to determine if the two types of exercise programs (supervised \& home exercise) result in health improvements for moms and babies. The investigators also want to see if the tests and questionnaires used in the study can detect changes in a mom's aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months after birth.

Detailed description: Historically, pregnant women were advised to refrain from exercise due to concerns of maternal and fetal risk such as preterm delivery, low infant birth rate and fetal stress. Despite current research that has demonstrated substantial benefits for maternal, fetal, and infant health, only 9-15% of pregnant women meet the current physical activity recommendations. In addition, pregnancy exercise research is confounded by a lack of randomized controlled trials (RCT) that include diversity in participant demographics, specifically inner city populations, and difficulty accurately quantifying weekly exercise volume. The investigators propose a pilot RCT investigating two different approaches to exercise intervention across a spectrum of demographics that the investigators believe will result in improved exercise adherence as well as in maternal and infant health outcomes. Specific Aim #1: To determine the feasibility of two types of exercise interventions (supervised \& home exercise) in terms of design, implementation and adherence. Our working hypothesis is that both supervised and home exercise interventions will be implementable as designed in pregnant women as evidenced by recruitment, eligibility, retention, follow-up and exercise adherence from 1st trimester through 6-months post-natal at a 60% rate, but that adherence to the two types of exercise interventions will differ by demographic. A secondary exploratory hypothesis is that the investigators will be able to successfully recruit and retain 50% of our pregnant women from the Syracuse Community Health Center (primarily women with lower resources). Specific Aim #2: To determine the appropriateness of the outcome measures proposed for the exercise intervention in detecting changes in maternal aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months post-natal as measured by the Balke Ware submaximal test; SF-12 Generic Quality of Life (QOL); Multidimensional Fatigue Inventory (MFI); Pittsburgh Sleep Quality Index (PSQLI); Center for Epidemiologic Studies Depression Scale (CES-D); Edinburgh Postnatal Depression Scale (EPDS); and the Pregnancy Physical Activity Questionnaire (PPAQ). Our working hypothesis is that the above outcome measures will be able to detect changes in maternal outcome measures in both exercise groups. Because this is a feasibility study, the results will be used as preliminary data to apply for future funding and also will provide variable quantitative and qualitative data for validating interventions that can increase adherence to exercise guidelines during pregnancy in women with different ethnic and socioeconomic backgrounds.

Eligibility criteria: Inclusion Criteria:

* Adult pregnant women (i.e. 18 years of age and older)
* Low risk, singleton pregnancy
* In first trimester of pregnancy (6 to 13 weeks gestation)
* Without absolute contraindications to moderate intensity exercise during pregnancy as defined by the American College of Obstetricians and Gynecologists
* Exercise clearance from OB/GYN

Exclusion Criteria:

* Pregnancies greater than low risk for any reason
* Pregnant with more than one fetus
* Absolute exercise contraindications and/or lack of exercise clearance from OB/GYN

Primary outcomes:
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 1 of infant's life
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 2 of infant's life
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 3 of infant's life
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 4 of infant's life
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 5 of infant's life
measure: The Bayley Scales of Infant Development, 4th edition
timeFrame: Month 6 of infant's life
measure: Balke-Ware Submaximal Test
timeFrame: Baseline (late first trimester)
measure: Balke-Ware Submaximal Test
timeFrame: 3 months post-delivery
measure: Balke-Ware Submaximal Test
timeFrame: 6 months post-delivery
Secondary outcomes:
measure: Short From-12 Generic Quality of Life
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Multidimensional Fatigue Inventory
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Edinburgh Postnatal Depression Scale
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Pregnancy Physical Activity Questionnaire
timeFrame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
measure: Height
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
measure: Weight
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Erin Wentz, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Upstate Medical University
name: Carol Sames, PhD
role: PRINCIPAL_INVESTIGATOR
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