The SPROUT (Pilot) Project (SPROUT)

November 9, 2022 updated by: Erin Wentz PT PhD PCS, State University of New York - Upstate Medical University

The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • 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
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Exercise
Women randomized to Supervised Exercise group will attend two to three exercise classes/week.
Behavioral: Supervised Exercise
Women randomized to Supervised Exercise group will attend two to three exercise classes/week. Each session will consist of: 5-min flexibility warm-up and cool-down; 40 min of moderate intensity calculated as 40-59% Heart Rate Reserve (HRR) along with Rating of Perceived Exertion (RPE) between 13-14; and 20 minutes of resistance with an additional 30 minutes of unsupervised home aerobic activity per week. The women will be given their choice of aerobic equipment or walking either track/ treadmill to achieve a total of 40 minutes of moderate intensity exercise. The Supervised Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.
Experimental: Home Exercise
Women assigned to Home Exercise group will receive instructions for their home walking and exercise program.
Behavioral: Home Exercise
Women assigned to Home Exercise group will receive instructions for their home walking program including tips for walking indoors and outdoors, exercise handouts for warm-up/cool-down activities, demonstrations for resistance training activities and an exercise log. Women assigned to Home Exercise group will be contacted once per week to discuss their progress, barriers/challenges faced, ask questions, and strategies to achieve the exercise guidelines. The Home Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.
No Intervention: Usual Care
The Usual Care group will receive an exercise log to record any weekly activity in addition to a weekly phone call/text/email to remind the individual to complete the weekly exercise log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 1 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 1 of infant's life
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 2 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 2 of infant's life
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 3 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 3 of infant's life
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 4 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 4 of infant's life
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 5 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 5 of infant's life
The Bayley Scales of Infant Development, 4th edition
Time Frame: Month 6 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Month 6 of infant's life
Balke-Ware Submaximal Test
Time Frame: Baseline (late first trimester)
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Baseline (late first trimester)
Balke-Ware Submaximal Test
Time Frame: 3 months post-delivery
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
3 months post-delivery
Balke-Ware Submaximal Test
Time Frame: 6 months post-delivery
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
6 months post-delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short From-12 Generic Quality of Life
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
A self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Multidimensional Fatigue Inventory
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
A 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher total scores correspond with more acute levels of fatigue.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pittsburgh Sleep Quality Index
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Possible range of scores is 0 to 21, with higher scores indicating worse sleep quality.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Center for Epidemiologic Studies Depression Scale
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
A 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Edinburgh Postnatal Depression Scale
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Evaluates whether a woman has symptoms of depression and anxiety during pregnancy and in the year following the birth of a child. Possible range of scores is 0 to 30. Mothers scoring above 12 are likely to be suffering from depression.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pregnancy Physical Activity Questionnaire
Time Frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Self-administered semiquantitative questionnaire for assessing typical physical activity, occupational activity, and home activity completed. From the questionnaire, the number of hours spent in each activity is multiplied by the activity intensity to arrive at a measure of average daily energy expenditure (MET-hours per day) attributable to each activity.
Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Height
Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Infant height in centimeters
Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Weight
Time Frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Infant weight in kilograms
Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life

Collaborators and Investigators

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

Sponsor

State University of New York - Upstate Medical University

Investigators

  • Principal Investigator: Erin Wentz, PT, PhD, State University of New York - Upstate Medical University
  • Principal Investigator: Carol Sames, PhD, State University of New York - Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

October 4, 2020

Primary Completion (Actual)

May 24, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPROUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because this information is a feasibility study, the investigators will continue to use this study to apply for future grants and it is not possible to determine when this will be complete.

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.

Clinical Trials on Pregnancy Related

Clinical Trials on Supervised Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe