#BabyLetsMove Physical Activity Feasibility Trial
#BabyLetsMove: A Feasibility Study of a mHealth Physical Activity Intervention for Perinatal Adolescents
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39216
- Mississippi State Department of Health
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physical activity
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body weight
Time Frame: Baseline, pre-intervention
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BodyTrace scale with Bluetooth
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Baseline, pre-intervention
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Readiness for physical activity in pregnancy
Time Frame: 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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: 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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: 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
Time Frame: Baseline, pre-intervention
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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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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Organizational Identification
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: work pace
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: cognitive demands
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: emotional demands
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: demands for hiding emotions
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: influence
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: possibilities for development
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: variation of work
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: meaning of work
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: commitment to the workplace
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: predictability
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: rewards (recognition)
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: role clarity
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: role conflicts
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: perceived quality of leadership
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: social support from supervisor
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: social support from colleagues
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: social community at work
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: job insecurity
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: perceived job satisfaction
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: work-family conflict
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: family-work conflict
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: trust regarding management
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: mutual trust between employees
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: justice and respect
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: social responsibility
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: self rated health
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: burnout
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: stress
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: sleeping troubles
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: depressive symptoms
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: somatic stress symptoms
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: cognitive stress symptoms
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: perceived self-efficacy for life solving problems
Time Frame: Baseline, pre-intervention
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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
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Baseline, pre-intervention
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Psychosocial factors at work: conflicts and offensive behaviors
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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
Time Frame: Baseline, pre-intervention
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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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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2017-0024
- 1U54GM115428 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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