Clinical trial NCT05048433: Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
Official title: Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Implementation of Physical Activity Programs in Schools
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-17
Enrollment: 305
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop an implementation strategy to improve the use and sustainment of active learning in elementary schools and to conduct a feasibility study to evaluate the impact of the developed implementation strategy on the implementation and effectiveness of active learning.


Eligibility criteria: Inclusion Criteria:

* lead teachers who teach kindergarten to fifth grade
* children in kindergarten to fifth grade

Exclusion Criteria:

* non English or Spanish speaking

Primary outcomes:
measure: Acceptability of active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)
timeFrame: Baseline
measure: Acceptability of active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)
timeFrame: 6 months follow up
measure: Acceptability active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)
timeFrame: 12 months follow up
measure: Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery
timeFrame: 6 months
measure: Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery
timeFrame: 12 months
measure: Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer
timeFrame: baseline
measure: Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer
timeFrame: 6 month follow up
measure: Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer
timeFrame: 12 month follow up
Secondary outcomes:
measure: Health fitness as assessed by FitnessGram (body mass index)
timeFrame: baseline
measure: Health fitness as assessed by the FitnessGram (body mass index)
timeFrame: 6 months
measure: Health fitness as assessed by the FitnessGram (body mass index)
timeFrame: 12 month follow up
measure: Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
timeFrame: baseline
measure: Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
timeFrame: 6 month follow up
measure: Health fitness as assessed by number of participants who meet the FitnessGram aerobic capacity standard
timeFrame: 12 month follow up
measure: Academic Performance as assessed by Test scores
timeFrame: Baseline
measure: Academic Performance as assessed by Test scores
timeFrame: 6 month follow up
measure: Academic Performance as assessed by Test scores
timeFrame: 12 month follow up
measure: Implementation Fidelity as assessed by direct observation to assess quality
timeFrame: 6 month follow up
measure: Implementation Fidelity as assessed by direct observation to assess quality
timeFrame: 12 month follow up
measure: Implementation Fidelity as assessed by direct observation to assess adherence
timeFrame: 6 month follow up
measure: Implementation Fidelity as assessed by direct observation to assess adherence
timeFrame: 12 month follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Timothy J Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker TJ, Kohl HW 3rd, Bartholomew JB, Green C, Fernandez ME. Using Implementation Mapping to develop and test an implementation strategy for active learning to promote physical activity in children: a feasibility study using a hybrid type 2 design. Implement Sci Commun. 2022 Mar 7;3(1):26. doi: 10.1186/s43058-022-00271-9.