Trial Outcomes & Findings for H-PACE Program for the Improvement of Lifestyle Behaviors Among Children (NCT NCT06548074)
NCT ID: NCT06548074
Last Updated: 2026-07-14
Results Overview
Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Up to week 14
Results posted on
2026-07-14
Participant Flow
Recruitment occurred in 2 elementary schools in the Central Valley of WA state and 2 elementary schools in Las Cruces, NM. The New Mexico research team leveraged existing relationship with after-school program to identify schools to participate in this study. WA research team worked with district superintendent to identify 2 schools. Recruitment flyers were disseminated at each school, and research staff attended parent meetings to present the study and answer questions.
N/A; Single arm intervention to test feasibility. Prior to start of intervention 22 parent-child dyads in New Mexico and 39 parent-child dyads in Central Washington were recruited and completed informed consent/assent, for a total of 122 participants. Of those, 121 (60 parents and 61 children) completed a baseline survey.
Participant milestones
| Measure |
The Healthy Parents and Children Enhancement (H-PACE) Program
H-PACE Program is a 12-week educational program. The program consists of three parts: 1 - Educational component, 2 - Physical Activity (PA) component, and 3 - Snack component. The educational component includes 30-minute lessons on the importance of physical activity, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) is composed of a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component is designed to introduce children to tasty and healthy foods and to teach children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Once a week, children are involved in the preparation of healthy snack foods at home with parents by taking home fruit and vegetable boxes with recipes for family-based engaging activities.
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|---|---|
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Overall Study
STARTED
|
122
|
|
Overall Study
Parents Completed Baseline Survey
|
60
|
|
Overall Study
Kids Completed Baseline Survey
|
61
|
|
Overall Study
Kids Completed Baseline Accelerometer Reading
|
57
|
|
Overall Study
Kids Completed Intervention & Follow up Accelerometer Reading
|
54
|
|
Overall Study
Parents Completed all Assessments
|
53
|
|
Overall Study
Kids Completed all Assessments
|
52
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data represents 121 participants (60 parents and 61 children)
Baseline characteristics by cohort
| Measure |
The Healthy Parents and Children Enhancement (H-PACE) Program
n=121 Participants
H-PACE Program is a 12-week educational program. The program consists of three parts: 1 - Educational component, 2 - Physical Activity (PA) component, and 3 - Snack component. The educational component includes 30-minute lessons on the importance of physical activity, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) is composed of a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component is designed to introduce children to tasty and healthy foods and to teach children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Once a week, children are involved in the preparation of healthy snack foods at home with parents by taking home fruit and vegetable boxes with recipes for family-based engaging activities.
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|---|---|
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Age, Continuous
Kids
|
10 Years
STANDARD_DEVIATION 0.96 • n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Age, Continuous
Parents
|
39 Years
STANDARD_DEVIATION 9.1 • n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Sex: Female, Male
Kids · Female
|
35 Participants
n=60 Participants • One missing value.
|
|
Sex: Female, Male
Kids · Male
|
25 Participants
n=60 Participants • One missing value.
|
|
Sex: Female, Male
Parents · Female
|
51 Participants
n=60 Participants • One missing value.
|
|
Sex: Female, Male
Parents · Male
|
9 Participants
n=60 Participants • One missing value.
|
|
Race (NIH/OMB)
Kids · American Indian or Alaska Native
|
1 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · Asian
|
0 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · Black or African American
|
4 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · White
|
51 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · More than one race
|
1 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Kids · Unknown or Not Reported
|
4 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · American Indian or Alaska Native
|
1 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · Asian
|
0 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · Black or African American
|
4 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · White
|
52 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · More than one race
|
0 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Race (NIH/OMB)
Parents · Unknown or Not Reported
|
3 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Kids · Hispanic or Latino
|
57 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Kids · Not Hispanic or Latino
|
3 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Kids · Unknown or Not Reported
|
1 Participants
n=61 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Parents · Hispanic or Latino
|
55 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Parents · Not Hispanic or Latino
|
5 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
|
Ethnicity (NIH/OMB)
Parents · Unknown or Not Reported
|
0 Participants
n=60 Participants • Data represents 121 participants (60 parents and 61 children)
|
PRIMARY outcome
Timeframe: Up to week 14Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.
Outcome measures
| Measure |
The Healthy Parents and Children Enhancement (H-PACE) Program
n=61 Participants
H-PACE Program is a 12-week educational program. The program consists of three parts: 1 - Educational component, 2 - Physical Activity (PA) component, and 3 - Snack component. The educational component includes 30-minute lessons on the importance of physical activity, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) is composed of a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component is designed to introduce children to tasty and healthy foods and to teach children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Once a week, children are involved in the preparation of healthy snack foods at home with parents by taking home fruit and vegetable boxes with recipes for family-based engaging activities.
|
|---|---|
|
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)
|
51 Participants
|
PRIMARY outcome
Timeframe: Up to week 14Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.
Outcome measures
| Measure |
The Healthy Parents and Children Enhancement (H-PACE) Program
n=61 Participants
H-PACE Program is a 12-week educational program. The program consists of three parts: 1 - Educational component, 2 - Physical Activity (PA) component, and 3 - Snack component. The educational component includes 30-minute lessons on the importance of physical activity, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) is composed of a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component is designed to introduce children to tasty and healthy foods and to teach children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Once a week, children are involved in the preparation of healthy snack foods at home with parents by taking home fruit and vegetable boxes with recipes for family-based engaging activities.
|
|---|---|
|
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
Completed BL Survey
|
61 Participants
|
|
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
Completed BL Survey + BL Accelerometer
|
57 Participants
|
|
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
BL Survey + BL Accelerometer + FU Accelerometer + FU Survey
|
52 Participants
|
|
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
Completed BL Survey + BL Accelerometer + FU Accelerometer
|
54 Participants
|
Adverse Events
The Healthy Parents and Children Enhancement (H-PACE) Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place