Pregnancy Related Clinical Trial
— SPROUTOfficial title:
The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories
NCT number | NCT05394883 |
Other study ID # | SPROUT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 4, 2020 |
Est. completion date | June 8, 2022 |
Verified date | November 2022 |
Source | State University of New York - Upstate Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 8, 2022 |
Est. primary completion date | May 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | SUNY Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York - Upstate Medical University |
United States,
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* Note: There are 59 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | The Bayley Scales of Infant Development, 4th edition | 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 | |
Primary | Balke-Ware Submaximal Test | 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) | |
Primary | Balke-Ware Submaximal Test | 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 | |
Primary | Balke-Ware Submaximal Test | 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 | Short From-12 Generic Quality of Life | 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 | |
Secondary | Multidimensional Fatigue Inventory | 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 | |
Secondary | Pittsburgh Sleep Quality Index | 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 | |
Secondary | Center for Epidemiologic Studies Depression Scale | 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 | |
Secondary | Edinburgh Postnatal Depression Scale | 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 | |
Secondary | Pregnancy Physical Activity Questionnaire | 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 | |
Secondary | Height | Infant height in centimeters | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life | |
Secondary | Weight | Infant weight in kilograms | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life |
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