Physical Activity Clinical Trial
Official title:
Care2bWell: A Worksite Physical Activity & Wellness Program for Child Care Staff
Verified date | June 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 553 |
Est. completion date | May 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in moderate to vigorous physical activity (MVPA) | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in dietary intake | 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). | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in smoking/e-cigarette status | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in sleep quality | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in stress | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in Body Mass Index | 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). | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in waist circumference | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in cardiovascular fitness | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in strength | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in endurance | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in balance | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in child care center worksite wellness environment | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention | |
Secondary | Change in teacher physical activity practices | 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. | Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A |