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| ID | Type | Description | Link |
|---|---|---|---|
| AHA 20TPA35490099 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Cardiovascular disease (CVD) accounts for 1 in 4 deaths among women of reproductive age. Decreasing adverse pregnancy outcomes (APO), e.g. hypertensive disorders of pregnancy, gestational diabetes, and preterm birth, could reduce this burden. APOs have serious immediate health consequences and are recognized by the AHA as major risk factors for future CVD. Yet, APOs are hard to prevent and treat, with a 20% prevalence that is increasing in the U.S. Moderate-vigorous intensity physical activity (MVPA) reduces APOs, but less than 1 in 4 pregnant women achieve guidelines and pregnant women report unique barriers such as fatigue, pain, medical restriction, and concern for the baby.
Sitting, or 'sedentary behavior' (SED) is a novel risk factor for CVD. Yet, sparse research and no U.S. guidelines exist for SED in pregnancy. Our recent AHA-funded cohort study in pregnant women (n=120) objectively measured SED and MVPA during each trimester. While MVPA was not related to outcomes, pregnant women with high vs. low SED across pregnancy had greater odds of APO and gave birth to babies at a reduced gestational age. Considering that decreasing SED may be more feasible given the barriers to MVPA, the investigators hypothesize that a SED reduction intervention may be especially promising for reducing APOs and improving cardiovascular health for women and their children.
Given the dearth of SED research, trials, or guidelines for pregnant women, the investigators propose to use our preliminary data on behavioral targets, correlates, and determinants of SED during pregnancy to adapt our previously successful SED reduction interventions. This pilot and feasibility study will enroll newly pregnant women with high SED and elevated APO risk (n=53) and randomize them to either a SED reduction intervention or control (2:1 ratio). Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.
Participants will complete three assessment visits, one in each trimester, including 1-week monitoring of SED and activity patterns with a thigh-worn activPAL and blood pressure measurement using a standard protocol. Other outcomes will be assessed by self-report and medical record review after the participant gives birth. Participants randomized to the intervention arm will be provided with a fitbit, a sit-stand desk attachment, and will complete virtual health coaching visits every two weeks throughout pregnancy to facilitate reduced SED, increase standing, and increased stepping throughout the day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedentary Behavior Reduction Intervention | Experimental | Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. |
|
| Usual Care Control | Active Comparator | Printable information on physical activity recommendations only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedentary Behavior Reduction | Behavioral | Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed). |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary Time | objectively measured using activPAL3 micro | Randomization to study completion, about 6 months |
| Standing | Objectively measured using activPAL3 micro | Randomization to study completion, about 6 months |
| Steps Per Day | Objectively measured using activPAL3 micro | Randomization to study completion, about 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Participants screened for eligibility | Active recruitment phase, about 1 year |
| Retention | Number of randomized intervention and control participants remaining at each follow up timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany B Gibbs | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Department of Health and Human Development, 32 Oak Hill Court, Room 220 | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38605328 | Derived | Gibbs BB, Kozai AC, McAdoo SN, Davis KD, Savidge MB, Paley JL, Hauspurg A, Catov JM. The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial. BMC Pregnancy Childbirth. 2024 Apr 11;24(1):261. doi: 10.1186/s12884-024-06474-3. | |
| 37314845 | Derived | Barone Gibbs B, Kozai AC, McAdoo SN, Bastyr MC, Davis KD, Hauspurg A, Catov JM. Rationale, Design, and Methods for the Sedentary Behavior Reduction in Pregnancy Intervention (SPRING): Protocol for a Pilot and Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 14;12:e48228. doi: 10.2196/48228. |
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The investigators do not have plans to share data at this time and will not be collecting biospecimens as part of this protocol. In the future, reasonable requests for de-identified data from other scientists will be considered. Such data will be shared with approval by the Study PI and other investigators, as appropriate.
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A total of 51 first trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control.
SPRING is a pilot and feasibility randomized clinical trial conducted in the greater Pittsburgh, PA (United States) area between October 2021 and June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedentary Behavior Reduction Intervention | Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed). Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
| FG001 | Usual Care Control | Printable information on physical activity recommendations only Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedentary Behavior Reduction Intervention | Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed). Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sedentary Time | objectively measured using activPAL3 micro | Two participants were removed from this analysis due to miscarriage after randomization. | Posted | Mean | Standard Deviation | total hours/day | Randomization to study completion, about 6 months |
|
3 Months
Adverse events were collected from systematic questioning at assessment visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedentary Behavior Reduction Intervention | Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided. Sedentary Behavior Reduction: Participants receive bimonthly behavioral health coaching, a sit-stand desk attachment or table, and an activity prompter if they do not already have one (e.g., fitbit, as needed). Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID | Infections and infestations | Systematic Assessment | Hospitalized due to headaches and increased liver enzymes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mole Excision | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Benign mole excision from the bottom of foot |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bethany Barone Gibbs | West Virginia University | 304-581-1779 | behany.gibbs@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2023 | Nov 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |
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Research personnel conducting outcome assessments will be blinded to participant group assignment. As the participant will be receiving a behavioral intervention, both the participant and interventionist will be aware of group assignment.
| Information on Physical Activity Recommendations during Pregnancy | Behavioral | Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
|
| Beginning of randomization to 2nd trimester and 3rd trimester |
| Intervention Adherence to Behavioral Coaching Contacts | Percentage of intervention contacts completed. This includes behavioral lessons and check-ins. | Randomization to study completion, about 6 months |
| Outcome Assessment Rates | Number of participants that have complete objective sedentary time and other outcome data | Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization. |
| Physician Decision |
|
| BG001 | Usual Care Control | Printable information on physical activity recommendations only Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sedentary Time | Total sedentary time spent in a 24-hour day | Mean | Standard Deviation | hours/day |
|
| OG001 | Usual Care Control | Printable information on physical activity recommendations only Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. |
|
|
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| Primary | Standing | Objectively measured using activPAL3 micro | Two participants were removed from this analysis due to miscarriage after randomization. | Posted | Mean | Standard Deviation | hours/day | Randomization to study completion, about 6 months |
|
|
|
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| Primary | Steps Per Day | Objectively measured using activPAL3 micro | Two participants were removed from this analysis due to miscarriage after randomization. | Posted | Mean | Standard Deviation | steps per day | Randomization to study completion, about 6 months |
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|
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| Secondary | Recruitment | Participants screened for eligibility | Posted | Count of Participants | Participants | Active recruitment phase, about 1 year |
|
|
|
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| Secondary | Retention | Number of randomized intervention and control participants remaining at each follow up timepoint | Posted | Count of Participants | Participants | Beginning of randomization to 2nd trimester and 3rd trimester |
|
|
|
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| Secondary | Intervention Adherence to Behavioral Coaching Contacts | Percentage of intervention contacts completed. This includes behavioral lessons and check-ins. | Initially, there were 34 Intervention participants. One participant was removed from this Intention To Treat analysis due to miscarriage after randomization. | Posted | Mean | Full Range | percentage of contacts | Randomization to study completion, about 6 months |
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| Secondary | Outcome Assessment Rates | Number of participants that have complete objective sedentary time and other outcome data | Randomized participants with single gestation pregnancy | Posted | Count of Participants | Participants | Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization. |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 6 |
| 34 |
| EG001 | Usual Care Control | Printable information on physical activity recommendations only Information on Physical Activity Recommendations during Pregnancy: Participants in the study will receive educational materials provided one time by email about the currently recommended physical activity during pregnancy. | 0 | 17 | 1 | 17 | 6 | 17 |
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| UTI | Infections and infestations | Systematic Assessment | Urinary Tract Infection |
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| Neck, Spine, & TMJ Disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Prescribed physical therapy for neck, spine & TMJ pain related to past motor vehicle accident |
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| Headaches & Nosebleeds | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Frequent headaches & nosebleeds |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment | Increased heartburn concurrent with GI illness |
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| Start of New Medication | Psychiatric disorders | Systematic Assessment | Began taking Zoloft for symptoms of irritability |
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| Food Poisoning | Gastrointestinal disorders | Systematic Assessment | Food poisoning with emesis |
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| Mild and general tailbone discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Symphysis Pubis Diastasis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Hospitalized and prescribed bedrest due to pubic symphysis joint separation |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment | Began treatment for depression |
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| Anxiety | Psychiatric disorders | Systematic Assessment | Increased episodes of anxiety |
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| Low Iron Level | Blood and lymphatic system disorders | Systematic Assessment |
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