Pediatric ObesityNCT06548074
H-PACE Program for the Improvement of Lifestyle Behaviors Among Children
A study testing H-PACE Behavioral Intervention, Accelerometer and Questionnaire Administration in people with Pediatric Obesity, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial summary
This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- H-PACE Behavioral Intervention, Accelerometer and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children in 3rd - 5th grade, 8-11 years of age, attending the afterschool program at the selected elementary schools.
- Parents/Guardians of the eligible child, who are ≥ 18 years old.
- Fluency in English or Spanish.
Who cannot join
- Children who are not in 3rd - 5th grade.
- Children not attending the afterschool program at the selected elementary schools.
- Parents/Guardians of the eligible child, who are < 18 years old.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Mexico State University
Las Cruces, New Mexico, 88003
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement (H-PACE) Program
This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.
Read the detailed description
OUTLINE:
Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises 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 introduces children to tasty and healthy foods and teaches 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). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.
- Conditions
- Pediatric Obesity
- Being tested
- H-PACE Behavioral Intervention, Accelerometer, Questionnaire Administration, Supportive Care
- Keywords
- physical activity (exercise), sedentary activity, sleep, fruit, vegetable
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-PACE Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in the H-PACE program
AccelerometerOther
Wear an accelerometer
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Parents may participate in an optional virtual peer support group
| Study group | Role | What they receive |
|---|---|---|
| Prevention (H-PACE program) | Experimental | See Detailed Description. Receives: Behavioral: H-PACE Behavioral Intervention; Other: Accelerometer; Other: Questionnaire Administration; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)
Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric.
Measured: Up to week 14
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric.
Measured: Up to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start22 Jan 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), New Mexico State University
- Responsible party
- Principal investigator, Jason Mendoza, MD, MPH, Fred Hutchinson Cancer Center
- Investigators
- Jason Mendoza, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumDejan Magoc, PhD, Principal investigator, New Mexico State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548074
- Sponsor's protocol ID
- RG1124059
- Other IDs
- NCI-2024-05449, U54CA132381, FHIRB0020386
- Status last verified
- Jun 2026
- First submitted
- 26 Jul 2024
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement (H-PACE) Program
- ClinicalTrials.gov ID
- NCT06548074
- Acronym / sponsor ID
- RG1124059
- Conditions
- Pediatric Obesity
- Keywords
- physical activity (exercise), sedentary activity, sleep, fruit, vegetable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), New Mexico State University
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.
Detailed description
OUTLINE:
Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises 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 introduces children to tasty and healthy foods and teaches 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). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (H-PACE program) | Experimental | Behavioral: H-PACE Behavioral Intervention, Other: Accelerometer, Other: Questionnaire Administration, Other: Supportive CareSee Detailed Description. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children in 3rd - 5th grade, 8-11 years of age, attending the afterschool program at the selected elementary schools.
- Parents/Guardians of the eligible child, who are ≥ 18 years old.
- Fluency in English or Spanish.
Key exclusion criteria (3 listed)
- Children who are not in 3rd - 5th grade.
- Children not attending the afterschool program at the selected elementary schools.
- Parents/Guardians of the eligible child, who are < 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H-PACE Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in the H-PACE program | Behavioural | Prevention (H-PACE program) |
| AccelerometerWear an accelerometer | Other | Prevention (H-PACE program) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (H-PACE program) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveParents may participate in an optional virtual peer support group | Other | Prevention (H-PACE program) |
Primary outcome
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)
Time frame: Up to week 14
Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric.
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)
Time frame: Up to week 14
Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if > 75% of participants meet the metric.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Mendoza, MD, MPH principal investigator
Fred Hutch/University of Washington Cancer Consortium
Dejan Magoc, PhD principal investigator
New Mexico State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-PACE Behavioral Intervention, Accelerometer and Questionnaire Administration in people with Pediatric Obesity, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility) (time frame: Up to week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.