- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04628065
#BabyLetsMove Physical Activity Feasibility Trial
perjantai 5. elokuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
14
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
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Mississippi
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Jackson, Mississippi, Yhdysvallat, 39216
- Mississippi State Department of Health
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
15 vuotta - 19 vuotta (Lapsi, Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Physical activity
Aikaikkuna: Baseline, pre-intervention
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Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
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Baseline, pre-intervention
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Sedentary time
Aikaikkuna: Baseline, pre-intervention
|
Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
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Baseline, pre-intervention
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Body weight
Aikaikkuna: Baseline, pre-intervention
|
BodyTrace scale with Bluetooth
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Baseline, pre-intervention
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Readiness for physical activity in pregnancy
Aikaikkuna: Baseline, pre-intervention
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Single response item to categorize readiness to engage in physical activity; Haakstad et al., 2013 (PMID:23431448)
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Baseline, pre-intervention
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Self-efficacy for physical activity
Aikaikkuna: 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
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Baseline, pre-intervention
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Self-efficacy for overcoming self-identified barriers to physical activity
Aikaikkuna: 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
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Baseline, pre-intervention
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Self-efficacy for limiting sedentary time
Aikaikkuna: 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;
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Baseline, pre-intervention
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Self-regulation: Goal-Setting
Aikaikkuna: Baseline, pre-intervention
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Exercise Goal-Setting Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely
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Baseline, pre-intervention
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Self-regulation: Planning
Aikaikkuna: 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
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Baseline, pre-intervention
|
Decisional balance
Aikaikkuna: 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
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Baseline, pre-intervention
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Perceived exercise safety in pregnancy
Aikaikkuna: Baseline, pre-intervention
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Exercise Safety Scale; 14 items rated using a 4-point Likert scale from 1, very unsafe to 4, very safe
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Baseline, pre-intervention
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Perceived daily physical activity behavior
Aikaikkuna: 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
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Baseline, pre-intervention
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Organizational Identification
Aikaikkuna: 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
Aikaikkuna: 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
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Baseline, pre-intervention
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Organizational Climate
Aikaikkuna: Baseline, pre-intervention
|
Organizational Climate Survey; 28-items using a 6-point Likert scale from strongly disagree to 6, strongly agree
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Baseline, pre-intervention
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Psychosocial factors at work: quantitative demands
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
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Baseline, pre-intervention
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Gamble A, Baskin ML, Cranston KL, Herring SJ, Hinton E, Saulters MM, Moore JB, Welsch MA, Beech BM. Effects of eHealth interventions on physical activity and weight among pregnant and postpartum women and the sociodemographic characteristics of study populations: a systematic review protocol. JBI Evid Synth. 2020 Nov;18(11):2396-2403. doi: 10.11124/JBISRIR-D-19-00378.
- Gamble A, Saulters MM, Cranston KL, Jones DW, Herring SJ, Beech BM. Recruitment, Retention, and Engagement Strategies for Exercise Interventions With Rural Antenatal Adolescents: Qualitative Interviews With WIC Providers. J Public Health Manag Pract. 2020 Sep/Oct;26(5):497-502. doi: 10.1097/PHH.0000000000001027.
- Gamble A, Beech BM, Blackshear C, Cranston KL, Herring SJ, Moore JB, Welsch MA. Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement. Contemp Clin Trials. 2021 May;104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15.
- Gamble A, Beech BM, Blackshear C, Herring SJ, Welsch MA, Moore JB. Changes in Physical Activity and Television Viewing From Pre-pregnancy Through Postpartum Among a Socioeconomically Disadvantaged Perinatal Adolescent Population. J Pediatr Adolesc Gynecol. 2021 Dec;34(6):832-838. doi: 10.1016/j.jpag.2021.06.009. Epub 2021 Jul 13.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 1. maaliskuuta 2021
Ensisijainen valmistuminen (Todellinen)
Torstai 30. kesäkuuta 2022
Opintojen valmistuminen (Todellinen)
Torstai 30. kesäkuuta 2022
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 30. lokakuuta 2020
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 12. marraskuuta 2020
Ensimmäinen Lähetetty (Todellinen)
Perjantai 13. marraskuuta 2020
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 8. elokuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 5. elokuuta 2022
Viimeksi vahvistettu
Maanantai 1. elokuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2017-0024
- 1U54GM115428 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
Given this is a single arm feasibility study with 20 participants, individual participant data will not be shared with other researchers.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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