- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04628065
#BabyLetsMove Physical Activity Feasibility Trial
5 augusti 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- Mississippi State Department of Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 19 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physical activity
Tidsram: 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
|
Sedentary time
Tidsram: Baseline, pre-intervention
|
Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
|
Baseline, pre-intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Body weight
Tidsram: Baseline, pre-intervention
|
BodyTrace scale with Bluetooth
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Baseline, pre-intervention
|
Readiness for physical activity in pregnancy
Tidsram: Baseline, pre-intervention
|
Single response item to categorize readiness to engage in physical activity; Haakstad et al., 2013 (PMID:23431448)
|
Baseline, pre-intervention
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Self-efficacy for physical activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Perceived daily physical activity behavior
Tidsram: 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
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Organizational Identification
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2021
Primärt slutförande (Faktisk)
30 juni 2022
Avslutad studie (Faktisk)
30 juni 2022
Studieregistreringsdatum
Först inskickad
30 oktober 2020
Först inskickad som uppfyllde QC-kriterierna
12 november 2020
Första postat (Faktisk)
13 november 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 augusti 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 augusti 2022
Senast verifierad
1 augusti 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017-0024
- 1U54GM115428 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Given this is a single arm feasibility study with 20 participants, individual participant data will not be shared with other researchers.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Graviditetsrelaterad
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University of Southern DenmarkVejle Hospital; Vejle KommuneAvslutadHRQOL (Health Related Quality Of Life)Danmark
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University of Southern DenmarkNaestved HospitalAvslutadHRQOL (Health Related Quality of Quality)Danmark
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University of MalayaOkändTranspalatal Arch (TPA) | Oral Health Related Quality of Life (OHRQoL) | Oral Health Impact Profile Short Version 14 (OHIP 14) | Ortodontisk smärta | Tredimensionell (3D) ortodontisk anordningMalaysia
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Hospices Civils de LyonAvslutadNeuromyelit Optica Spectrum Disorders | Neuromyelit Optica Spectrum Related DisordersFrankrike
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekryteringCirros, lever | HELLP syndrom | Intrahepatisk kolestas av graviditet | Graviditetssjukdom | AFLP - Acute Fatty Lever of PregnancyStorbritannien