- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04628065
#BabyLetsMove Physical Activity Feasibility Trial
5. august 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- Mississippi State Department of Health
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Physical activity
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Body weight
Tidsramme: Baseline, pre-intervention
|
BodyTrace scale with Bluetooth
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Baseline, pre-intervention
|
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Readiness for physical activity in pregnancy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Decisional balance
Tidsramme: 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
Tidsramme: Baseline, pre-intervention
|
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
Tidsramme: 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
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Organizational Identification
Tidsramme: Baseline, pre-intervention
|
Organizational Identification Scale; 25-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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Inner Setting
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Psychosocial factors at work: work pace
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Psychosocial factors at work: variation of work
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Psychosocial factors at work: predictability
Tidsramme: 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)
Tidsramme: 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
|
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Psychosocial factors at work: role clarity
Tidsramme: 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
|
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Psychosocial factors at work: role conflicts
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Psychosocial factors at work: perceived job satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Psychosocial factors at work: conflicts and offensive behaviors
Tidsramme: 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
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Baseline, pre-intervention
|
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Occupational Self-efficacy for performing job-related duties
Tidsramme: Baseline, pre-intervention
|
Occupational Self-Efficacy Scale; 20-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 culture
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2021
Primær færdiggørelse (Faktiske)
30. juni 2022
Studieafslutning (Faktiske)
30. juni 2022
Datoer for studieregistrering
Først indsendt
30. oktober 2020
Først indsendt, der opfyldte QC-kriterier
12. november 2020
Først opslået (Faktiske)
13. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-0024
- 1U54GM115428 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Given this is a single arm feasibility study with 20 participants, individual participant data will not be shared with other researchers.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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