NCT02381938

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
553

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

February 17, 2015

Last Update Submit

June 15, 2018

Conditions

Physical Activity

Keywords

inactivitybehavior changeworksite wellnesschild care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in dietary intake

    Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention

  • Change in smoking/e-cigarette status

    Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention

  • Change in sleep quality

    Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention

  • Change in stress

    Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention

  • Change in Body Mass Index

    Measure collected 3-5 weeks prior to start of intervention and 1-5 weeks post intervention and repeated at 12-13 months post intervention

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

6-month intervention to increase physical activity and improve other health related behaviors

Behavioral: Healthy Lifestyles

Control

OTHER

6-month intervention to educate and improve financial health

Other: Healthy Finances

Interventions

Healthy LifestylesBEHAVIORAL

6-month intervention to increase physical activity and improve other health related behaviors

Intervention
Healthy FinancesOTHER

6-month intervention to educate and improve financial health

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Linnan LA, Vaughn AE, Smith FT, Westgate P, Hales D, Arandia G, Neshteruk C, Willis E, Ward DS. Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff. Int J Behav Nutr Phys Act. 2020 May 15;17(1):64. doi: 10.1186/s12966-020-00968-x.

    PMID: 32414381DERIVED

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dianne S Ward, EdD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Laura Linnan, ScD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

US(1)