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#BabyLetsMove Physical Activity Feasibility Trial

5. srpna 2022 aktualizováno: Abigail Gamble, University of Mississippi Medical Center

#BabyLetsMove: A Feasibility Study of a mHealth Physical Activity Intervention for Perinatal Adolescents

Black adolescents who are pregnant represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (<20 years) is disproportionately prevalent among Blacks compared with Whites and is a prominent risk factor for obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary time can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentarism among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. In the proposed study, investigators will assess the feasibility and acceptability of #BabyLetsMove, a mobile health intervention targeting three behavioral goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per day (physical activity); and (3) do 20 minutes or more of structured activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 Black adolescents (15- to 19-years) enrolled in Mississippi's Supplemental Nutritional Program for Women, Infants and Children (WIC) to test the intervention's feasibility and acceptability. Participants will receive one text message per day for 4-weeks targeting behavior change strategies and two health coaching sessions via mobile phone; an introduction session in week one and a problem-solving session in week three. Investigators will also use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content and materials. Finally, in preparation for a pilot study using an effectiveness-implementation hybrid study design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the culture and climate of WIC. Investigators hypothesize the #BabyLetsMove intervention will be acceptable to adolescents and a future pilot randomized controlled trial will be feasible. Investigators also anticipate identifying modifiable barriers and facilitators to implementing the intervention through WIC, which will help to design an implementation strategy with a high likelihood for uptake by WIC.

Přehled studie

Detailní popis

Formative research is needed to establish a foundation for obesity prevention research with high-risk, disadvantaged, perinatal adolescents and their offspring. In particular, Black pregnant adolescents in socioeconomically disadvantaged communities represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (<20 years) is disproportionately prevalent among Blacks compared with Whites (27.6 and 13.4 per 1,000, respectively) and is a prominent risk factor for obesity. Normal pubertal growth is associated with increased weight in adolescence and Black female and rural adolescents are at highest risk for excessive adiposity. Pregnancy exacerbates preexisting risks and predicates a trajectory of maternal and child obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary behavior can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentary behavior among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. To this end, investigators conducted formative work in the Teen Mom Study, an exploratory investigation to identify modifiable psychosocial, cultural and environmental determinants of physical activity among pregnant and postpartum adolescents enrolled in Mississippi's Supplemental Nutritional Program for Women Infants and Children (WIC) in the Mississippi Delta. WIC is a federally-funded, state-run public health service providing healthy food and nutrition counseling to low-income women, infants and children at nutritional risk. Public health services like WIC are ideal settings for the prevention and treatment of obesity among high-risk, socioeconomically disadvantaged populations. The Mississippi Delta is a culturally and geographically distinct 18-county rural region of Mississippi that is plagued by decades of persistent poverty, poor health and the highest teen birth rate, which has not declined since 2006, in the United States. Using data from the Teen Mom Study, investigators adapted an existing mobile health (mHealth) intervention to achieve three behavioral goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per day (physical activity; tracked using a FitBit provided to each study participant); and (3) do 20 minutes or more of structured activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 overweight or obese, Black, pregnant (<16 weeks) adolescent (15 - 19 years) WIC clients to test the feasibility and acceptability of the intervention. Participants will receive text messages aligned with theoretical behavior change strategies every day of the week for 4-weeks including: 1) four skills texts, which may be a simple text or a text with a link to either a PDF or video; 2) two goal monitoring text messages, which will check-in on the three behavior change goals; and 3) and one text message for participants to report their weight using a BodyTrace scale provided by the study. Text messages will be supplemented with two health coaching telephone calls conducted by the principal investigator; an introduction session in the first week, followed by a problem-solving session in week three. While the study goal is to assess feasibility and acceptability, physical activity assessed using accelerometry, subjective psychosocial constructs, and anthropometric and biomarker measures will be measured at pre- (week 1) and post- (week 6) intervention. To gain additional insight, investigators will use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content (text messages) and materials (PDFs and videos). Finally, in preparation for a randomized pilot trial using an effectiveness-implementation hybrid research design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the context, culture and climate of WIC (implementation measures identified in the Consolidated Framework for Implementation Research). Investigators hypothesize the #BabyLetsMove intervention materials will be acceptable to adolescents and that conducting a future pilot randomized controlled trial will be feasible. Investigators also anticipate identifying modifiable barriers and facilitators to implementing the intervention through WIC, which will help to design an implementation strategy with a high likelihood for uptake by WIC. If proven to be effective, #BabyLetsMove mHealth intervention may be a scalable approach to increase physical activity among socioeconomically disadvantaged adolescents at high risk for maternal and child obesity.

Typ studie

Intervenční

Zápis (Aktuální)

14

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Mississippi
      • Jackson, Mississippi, Spojené státy, 39216
        • Mississippi State Department of Health

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

15 let až 19 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • African American or Black
  • <16 weeks gestation
  • Overweight or obese
  • Enrolled in WIC
  • Resides in one of 13 Mississippi Delta Counties
  • Cohabitation with their mother
  • Has a personal smart phone

Exclusion Criteria:

  • Been told by a doctor they can not exercise

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention Arm
Participants will receive a text message everyday to build behavioral skills and practice self-monitoring of three behavior goals: (1) reduce TV time to less than 2 hours per day; (2) take 10,000 steps or more every day; (3) do 20 minutes or more of structures exercise like prenatal yoga or dance videos every day. Participants will also receive two health coaching mobile phone session; an introduction session and one problem solving session.
This intervention will use mobile phones to promote the adoption and maintenance of physical activity, exercise and reduced TV time among overweight or obese, Black, pregnant (<16 weeks) adolescents (15 - 19 years) enrolled in Mississippi's WIC program.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical activity
Časové okno: Baseline, pre-intervention
Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
Baseline, pre-intervention
Sedentary time
Časové okno: Baseline, pre-intervention
Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
Baseline, pre-intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Body weight
Časové okno: Baseline, pre-intervention
BodyTrace scale with Bluetooth
Baseline, pre-intervention
Readiness for physical activity in pregnancy
Časové okno: Baseline, pre-intervention
Single response item to categorize readiness to engage in physical activity; Haakstad et al., 2013 (PMID:23431448)
Baseline, pre-intervention
Self-efficacy for physical activity
Časové okno: Baseline, pre-intervention
5-item survey to assess confidence in doing 20-minutes or more of moderate intensity on 1 day per week, 2 days, 3 days, 4 days, and 5 or more days; 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident
Baseline, pre-intervention
Self-efficacy for overcoming self-identified barriers to physical activity
Časové okno: Baseline, pre-intervention
Up to 4-item instrument to list perceived barriers to physical activity and rating confidence to overcome each barrier using an 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident
Baseline, pre-intervention
Self-efficacy for limiting sedentary time
Časové okno: Baseline, pre-intervention
6-item instrument to rate confidence in limiting sedentary time using an 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident;
Baseline, pre-intervention
Self-regulation: Goal-Setting
Časové okno: Baseline, pre-intervention
Exercise Goal-Setting Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely
Baseline, pre-intervention
Self-regulation: Planning
Časové okno: Baseline, pre-intervention
Exercise Planning Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely
Baseline, pre-intervention
Decisional balance
Časové okno: Baseline, pre-intervention
Pros and Cons of Reducing TV Time; 11-items rated using 4-point Likert scale from 1, strongly disagree to 4, strongly agree
Baseline, pre-intervention
Perceived exercise safety in pregnancy
Časové okno: Baseline, pre-intervention
Exercise Safety Scale; 14 items rated using a 4-point Likert scale from 1, very unsafe to 4, very safe
Baseline, pre-intervention
Perceived daily physical activity behavior
Časové okno: Baseline, pre-intervention
Pregnancy Physical Activity Questionnaire; 32-item survey to assess type and duration of physical activities on a typical day within respective trimester using 6-point Likert scale from 0, non to 6, 3 or more hours per day
Baseline, pre-intervention

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Organizational Identification
Časové okno: Baseline, pre-intervention
Organizational Identification Scale; 25-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree
Baseline, pre-intervention
Inner Setting
Časové okno: Baseline, pre-intervention
Inner Setting Measures from the Consolidated Framework for Implementation Research; 34-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree
Baseline, pre-intervention
Organizational Climate
Časové okno: Baseline, pre-intervention
Organizational Climate Survey; 28-items using a 6-point Likert scale from strongly disagree to 6, strongly agree
Baseline, pre-intervention
Psychosocial factors at work: quantitative demands
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: work pace
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: cognitive demands
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: emotional demands
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: demands for hiding emotions
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: influence
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: possibilities for development
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: variation of work
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 2-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: meaning of work
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: commitment to the workplace
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: predictability
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 2-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: rewards (recognition)
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: role clarity
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: role conflicts
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: perceived quality of leadership
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: social support from supervisor
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: social support from colleagues
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: social community at work
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always
Baseline, pre-intervention
Psychosocial factors at work: job insecurity
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: perceived job satisfaction
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-11) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not relevant to 100, very satisfied
Baseline, pre-intervention
Psychosocial factors at work: work-family conflict
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 4-point Likert scale from 0, no not at all to 100, yes certainly
Baseline, pre-intervention
Psychosocial factors at work: family-work conflict
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 4-point Likert scale from 0, no not at all to 100, yes certainly
Baseline, pre-intervention
Psychosocial factors at work: trust regarding management
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: mutual trust between employees
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: justice and respect
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: social responsibility
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent
Baseline, pre-intervention
Psychosocial factors at work: self rated health
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 1-item using a 5-point Likert scale from 0, poor to 100, excellent
Baseline, pre-intervention
Psychosocial factors at work: burnout
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: stress
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: sleeping troubles
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: depressive symptoms
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: somatic stress symptoms
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: cognitive stress symptoms
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time
Baseline, pre-intervention
Psychosocial factors at work: perceived self-efficacy for life solving problems
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 6-items using a 4-point Likert scale from 0, does not fit to 100, fits perfectly
Baseline, pre-intervention
Psychosocial factors at work: conflicts and offensive behaviors
Časové okno: Baseline, pre-intervention
Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 7-items using 5-point Likert scale from 0, no to 100, yes, daily
Baseline, pre-intervention
Occupational Self-efficacy for performing job-related duties
Časové okno: Baseline, pre-intervention
Occupational Self-Efficacy Scale; 20-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree
Baseline, pre-intervention
Organizational culture
Časové okno: Baseline, pre-intervention
Competing Values Culture Assessment; 6-dimensions, 48-items assessing the present and future where the sum of 4-items per column (present; future) must equal 100; provides insight on how provider perceives the organization to be and must change to be in order to accomplish its highest objectives and goals
Baseline, pre-intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2021

Primární dokončení (Aktuální)

30. června 2022

Dokončení studie (Aktuální)

30. června 2022

Termíny zápisu do studia

První předloženo

30. října 2020

První předloženo, které splnilo kritéria kontroly kvality

12. listopadu 2020

První zveřejněno (Aktuální)

13. listopadu 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. srpna 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. srpna 2022

Naposledy ověřeno

1. srpna 2022

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Given this is a single arm feasibility study with 20 participants, individual participant data will not be shared with other researchers.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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