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Trial record 1 of 1 for:    NCT02381938
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Care2BWell: Worksite Wellness for Child Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381938
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This study will evaluate the efficacy of a 6-month child care-based intervention to improve workers' physical activity and other health-related behaviors compared to an attention control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a cluster randomized design and a sample of 104 child care centers and 416 child care workers (4 workers/center). The intervention arm will receive a 6-month child care-based intervention designed to improve workers' moderate to vigorous physical activity (MVPA) and other health-related behaviors (Healthy Lifestyles). The control arm (attention control) will receive a similarly structured program about financial health (Healthy Finances). The primary outcome is workers' MVPA; and secondary outcomes include workers' dietary intake, weight, smoking, sleep, and stress, as well as the centers' health supportive policies/structures for staff wellness and the overall physical activity environment for children. All primary and secondary outcomes will be assessed at baseline, post-intervention (6 months), and maintenance (18 months).

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Healthy Lifestyles Other: Healthy Finances Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 553 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Care2bWell: A Worksite Physical Activity & Wellness Program for Child Care Staff
Study Start Date : March 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
6-month intervention to increase physical activity and improve other health related behaviors
Behavioral: Healthy Lifestyles
6-month intervention to increase physical activity and improve other health related behaviors

Control
6-month intervention to educate and improve financial health
Other: Healthy Finances
6-month intervention to educate and improve financial health




Primary Outcome Measures :
  1. Change in moderate to vigorous physical activity (MVPA) [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Child care center staff members' MVPA will be assessed using accelerometers. Staff will wear a GT3X+ accelerometer for 7 days, for 24 hours a day (during all waking and sleeping hours), except when bathing or participating in swimming/water activities. Monitors will be programmed to sample acceleration at 30 Hz. Each monitor will be placed onto an adjustable belt that allows the monitor to be worn comfortably over the right hip. Adult cut-points will be applied to calculate minutes of sedentary, light, moderate and vigorous activity. Minutes of moderate to vigorous physical activity (MVPA) will be used as the primary outcome. Monitors will be distributed during the on-site visits to centers so that research assistants can adjust the belt to the appropriate length for each worker.


Secondary Outcome Measures :
  1. Change in dietary intake [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Dietary intake will be assessed with a modified version of the Dietary Screener Questionnaire used in the National Health and Nutrition Examination Survey. Estimated intakes from this screener have moderate to high correlations (0.5 to 0.8) with estimated intakes from dietary recalls. The modified version used in this study will retain original items assessing fruits, vegetables, fiber/whole grains, added sugars, diary/calcium, and red and processed meat. In addition, some items will be merged (e.g., soda and sweetened fruit drinks asked as one item), others will be eliminated (e.g., salsa, pizza, tomato sauce), and a few new items will be added (e.g., dark green vegetables, eggs, lean meats, seafood, salty snacks, premade foods, dining out).

  2. Change in smoking/e-cigarette status [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Use of tobacco and e-cigarettes will be assessed using four items, modified from the Behavioral Risk Factor Surveillance System Questionnaire. Items ask participants to estimate average use of tobacco and e-cigarettes based on their behavior during the past 30 days.

  3. Change in sleep quality [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Items ask participants to report on average hours of sleep per night and overall quality during the past month.

  4. Change in stress [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Stress will be measured using items extracted from the Society for Behavioral Medicine's Common Data Elements, the Center for Epidemiologic Studies Depression Scale (CES-D), the Job Content Questionnaire, and previous studies. The CES-D is a assessment of depressive symptomology captures feeling of sadness, loss of interest, appetite disruption, sleep disruption, inability to think/concentrate, guilt, fatigue, agitation, and suicidal ideation. The Job Content Questionnaire assesses psychological demands resulting from one's job/occupation. For this study, items will be extracted to capture the constructs of psychological demands and decisional latitude.

  5. Change in Body Mass Index [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' height and weight will be collected by trained research assistants during the center visit. Height will be measured to the nearest 1/8 inch with a Shorr measuring board (Shorr Productions, Olney, MD). Weight will be measured to the nearest 0.1 lb. with a Seca model 874 portable electronic scale (Seca Corporation, Columbia, MD). Height and weight measures will be used to calculate BMI (weight in kg/height in meters2) and weight status (underweight=BMI <18.5, normal weight = BMI 18.5-24.9, overweight = BMI 25.0-29.9, obese = BMI ≥30.0).

  6. Change in waist circumference [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' waist circumference will be collected by trained research assistants during the center visit. Waist circumference will be measured to the nearest 0.1 cm with a Gulick II measuring tape.

  7. Change in cardiovascular fitness [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' health will also be assessed with a series of biomedical health assessments which capture various indicators of fitness including cardiovascular fitness determined via resting/seated heart rate, resting/seated blood pressure and a 6-minute walk assessment. These assessments will be conducted by trained research assistants during the kick-off event.

  8. Change in strength [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' health will also be assessed with a series of biomedical health assessments which capture various indicators of fitness including strength via the hand grip test. These assessments will be conducted by trained research assistants during the kick-off event.

  9. Change in endurance [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' health will also be assessed with a series of biomedical health assessments which capture various indicators of fitness including endurance via the chair sit and stand test. These assessments will be conducted by trained research assistants during the kick-off event.

  10. Change in balance [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Staff members' health will also be assessed with a series of biomedical health assessments which capture various indicators of fitness including balance via the 4-phase balance test. This assessment will be conducted by trained research assistants during the kick-off event.

  11. Change in child care center worksite wellness environment [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Child care centers' programs, policies and environment around worksite wellness will be assessed with a Worksite Wellness Audit (WWA). The WWA has been developed specifically for this study, drawing on existing assessment protocols like the CDC Worksite Health Scorecard and Wisconsin's Worksite Assessment Checklist. The new tool will assess the five key elements which define a "comprehensive" wellness program (administrative supports, health education programs, environmental supports, linkage with other health programs, and screening + adequate follow-up). The WWA will incorporate three components: a director interview, an environmental scan, and a staff survey. Trained research assistants will conduct the director interview and environmental scan during the on-site visit. The staff survey will be completed as part of the online surveys.

  12. Change in teacher physical activity practices [ Time Frame: Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention ]
    Teachers' interactions with children around physical activity will be assessed using an extracted set of items from the Environment and Policy Assessment and Observation - Self-Report (EPAO-SR) protocol. These items will be presented as part of a paper survey, which trained research assistants will distribute to classroom teachers during the on-site visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have been in business for at least 2 years in order to demonstrate business stability and minimize participant loss-to-follow-up due to closing of centers.
  • Must be planning to remain in business for at least the next 18 months to ensure our ability to collect follow-up data.
  • Must have at least 4 workers (1 director/assistant director and 3 staff) who are willing to take part in the study and agree to study protocols - participation in three data collection time points, attendance at a kick-off event, and acceptance of random assignment.
  • Center staff must speak and read English.

Exclusion Criteria:

  • been in business for less than 2 years
  • plans to close in the next 18 months
  • director/assistant director unwilling to participate
  • less than 3 child care staff willing to participate
  • child care staff do not read and speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381938


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Dianne S Ward, EdD University of North Carolina, Chapel Hill
Principal Investigator: Laura Linnan, ScD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02381938    
Other Study ID Numbers: 13-2438
1R01HL119568 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by University of North Carolina, Chapel Hill:
inactivity
behavior change
worksite wellness
child care