Health BehaviorNCT05563506
The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices
A study testing Healthy Kids + in people with Health Behavior, run by New Mexico State University at 2 sites in United States.
Trial summary
The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Healthy Kids +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 8-11 years enrolled in the after-school program at the selected sites.
Who cannot join
- Children not enrolled in the after-school program at the selected sites.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Heights Elementary School
Las Cruces, New Mexico, 88001
University Hills Elementary
Las Cruces, New Mexico, 88001
About this study
The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.
Read the detailed description
The purpose of this study is to implement and evaluate the Healthy Kids+ initiative -- a community-engaged research project - through an existing after-school program in Las Cruces, NM. The Healthy Kids+ initiative will encourage daily lifestyle behaviors (5 or more servings of fruits and vegetables, 2 hours or less of recreational screen time, 1 hour of physical activity, 0 sugary drinks, 10 hours of sleep) that impact childhood obesity. This research project will integrate lessons and activities designed to help kids incorporate changes into their lives to enhance their health and wellness. Overall, it is expected that children participating in the Healthy Kids+ initiative, three times per week, will demonstrate significant changes in improving lifestyle behaviors and maintaining both cognitive and affective changes.Healthy Kids+ will be integrated into the 21st Century afterschool program to provide children at the school sites with relevant PA and health related programming throughout the year. The proposed study will include a repeated-measures research design. A power analysis revealed that for a moderate effect size (f = .25, Cohen, 1988), with five percent type I error and 80% power, three follow up time points, and within subject's correlation of 0.5, we will need to recruit at a minimum 100 total participants. However, our potential participant pool is much larger, and thus we plan on over recruiting (N = 200) to mitigate lost data from attrition rates. The Healthy Kids+ program will be implemented three times a week for 30 weeks. A midyear assessment will be conducted 15-weeks into the program. Participants will then take part in a post assessment at the completion of the 30-week program. The primary quantitative outcome measures include levels of lifestyle behaviors (PA, healthy eating habits, screen time, sleep). The outcome measures will also include self-efficacy, self-esteem, and the level of readiness to change relevant to aforementioned lifestyle behaviors.
Based on Healthy Kids+, we revised and partnered with Fred Hutchinson Cancer Center to expand this trial. For this follow up project, we will recruit 30 children total at NMSU. For this follow up project, we will use accelerometer to objectively measure physical activity and sleep, as well as validated surveys measures for dietary intake and related health outcomes.
- Conditions
- Health Behavior
- Being tested
- Healthy Kids +
- Keywords
- physical activity, dietary intake, use of technology, sleep
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Kids +Behavioural
Three times a week for 30 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Kids + | Experimental | Three times a week for 30 weeks with each session lasting 1 hour. Receives: Behavioral: Healthy Kids + |
What is being measured
The primary outcome is the main question the study is designed to answer.
After-School Student Questionnaire (ASSQ)
A self-administered questionnaire that measures the behavioral and psychosocial variables targeted by the intervention. ASSQ survey items were modified from the Health Behavior Questionnaire and the School-Based Nutrition Monitoring Student Questionnaire, both of which have been found to have acceptable internal consistency (greater than 0.6). Measured constructs in the ASSQ included: food preferences, dietary knowledge, self-efficacy, intentions to choose healthful food options, and participation in sedentary and sports activities.
Measured: 2 weeks
Secondary outcomes (2)
Children's Sleep Habits Questionnaire (CSHQ)
A parent-rated questionnaire that assesses the frequency of behaviors associated with common pediatric sleep difficulties. A retrospective measure, the CSHQ instructs parents to rate the frequency with which their child has displayed various sleep behaviors during the previous week.
Measured: 1 week
Physical Activity Questionnaire for Children (PAQ-C)
A self-administered, 7-day recall instrument, developed to assess general levels of physical activity for students in grades 4 to 8 and approximately 8 to 14 years of age.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start23 Jan 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico State University
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutch
- Responsible party
- Principal investigator, Dejan Magoc, New Mexico State University
- Investigators
- Dejan Magoc, PhD, Principal investigator, New Mexico State UniversityJason Mendoza, PhD, Principal investigator, Fred Hutch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563506
- Sponsor's protocol ID
- 22769 / 220600102
- Other IDs
- 2U54CA132383-16 5016, 2U54CA132383-16
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained on all standardized measures at baseline and post intervention will be shared with investigators both internal and external to New Mexico State University. Any type of dissemination of results from the project will not identify individual patients. Access levels will be set to protect subject identification and unique identifiers linked to participant identity will be stripped, (i.e., data will be de-identified).
Publications
Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
PubMed 10925833Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
PubMed 3432232Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.
PubMed 12054320Steinhardt MA, Dishman RK. Reliability and validity of expected outcomes and barriers for habitual physical activity. J Occup Med. 1989 Jun;31(6):536-46. doi: 10.1097/00043764-198906000-00011.
PubMed 2786559Kelder S, Hoelscher DM, Barroso CS, Walker JL, Cribb P, Hu S. The CATCH Kids Club: a pilot after-school study for improving elementary students' nutrition and physical activity. Public Health Nutr. 2005 Apr;8(2):133-40. doi: 10.1079/phn2004678.
PubMed 15877906Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
PubMed 11145319
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices
- ClinicalTrials.gov ID
- NCT05563506
- Acronym / sponsor ID
- 22769 / 220600102
- Conditions
- Health Behavior
- Keywords
- physical activity, dietary intake, use of technology, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New Mexico State UniversityUniversity, hospital or other
- Collaborators
- Fred Hutch
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.
Detailed description
The purpose of this study is to implement and evaluate the Healthy Kids+ initiative -- a community-engaged research project - through an existing after-school program in Las Cruces, NM. The Healthy Kids+ initiative will encourage daily lifestyle behaviors (5 or more servings of fruits and vegetables, 2 hours or less of recreational screen time, 1 hour of physical activity, 0 sugary drinks, 10 hours of sleep) that impact childhood obesity. This research project will integrate lessons and activities designed to help kids incorporate changes into their lives to enhance their health and wellness. Overall, it is expected that children participating in the Healthy Kids+ initiative, three times per week, will demonstrate significant changes in improving lifestyle behaviors and maintaining both cognitive and affective changes.Healthy Kids+ will be integrated into the 21st Century afterschool program to provide children at the school sites with relevant PA and health related programming throughout the year. The proposed study will include a repeated-measures research design. A power analysis revealed that for a moderate effect size (f = .25, Cohen, 1988), with five percent type I error and 80% power, three follow up time points, and within subject's correlation of 0.5, we will need to recruit at a minimum 100 total participants. However, our potential participant pool is much larger, and thus we plan on over recruiting (N = 200) to mitigate lost data from attrition rates. The Healthy Kids+ program will be implemented three times a week for 30 weeks. A midyear assessment will be conducted 15-weeks into the program. Participants will then take part in a post assessment at the completion of the 30-week program. The primary quantitative outcome measures include levels of lifestyle behaviors (PA, healthy eating habits, screen time, sleep). The outcome measures will also include self-efficacy, self-esteem, and the level of readiness to change relevant to aforementioned lifestyle behaviors.
Based on Healthy Kids+, we revised and partnered with Fred Hutchinson Cancer Center to expand this trial. For this follow up project, we will recruit 30 children total at NMSU. For this follow up project, we will use accelerometer to objectively measure physical activity and sleep, as well as validated surveys measures for dietary intake and related health outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Kids + | Experimental | Behavioral: Healthy Kids +Three times a week for 30 weeks with each session lasting 1 hour. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 8-11 years enrolled in the after-school program at the selected sites.
Key exclusion criteria (1 listed)
- Children not enrolled in the after-school program at the selected sites.
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 |
|---|---|---|
| Healthy Kids +Three times a week for 30 weeks. | Behavioural | Healthy Kids + |
Primary outcome
After-School Student Questionnaire (ASSQ)
Time frame: 2 weeks
A self-administered questionnaire that measures the behavioral and psychosocial variables targeted by the intervention. ASSQ survey items were modified from the Health Behavior Questionnaire and the School-Based Nutrition Monitoring Student Questionnaire, both of which have been found to have acceptable internal consistency (greater than 0.6). Measured constructs in the ASSQ included: food preferences, dietary knowledge, self-efficacy, intentions to choose healthful food options, and participation in sedentary and sports activities.
2 secondary outcomes
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: 1 week
Physical Activity Questionnaire for Children (PAQ-C)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 10925833Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Background: PubMed 3432232Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Background: PubMed 12054320Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.
- Background: PubMed 2786559Steinhardt MA, Dishman RK. Reliability and validity of expected outcomes and barriers for habitual physical activity. J Occup Med. 1989 Jun;31(6):536-46. doi: 10.1097/00043764-198906000-00011.
- Background: PubMed 15877906Kelder S, Hoelscher DM, Barroso CS, Walker JL, Cribb P, Hu S. The CATCH Kids Club: a pilot after-school study for improving elementary students' nutrition and physical activity. Public Health Nutr. 2005 Apr;8(2):133-40. doi: 10.1079/phn2004678.
- Background: PubMed 11145319Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
- Individual participant dataSharing planned: Yes. Data obtained on all standardized measures at baseline and post intervention will be shared with investigators both internal and external to New Mexico State University. Any type of dissemination of results from the project will not identify individual patients. Access levels will be set to protect subject identification and unique identifiers linked to participant identity will be stripped, (i.e., data will be de-identified).
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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.
Dejan Magoc, PhD principal investigator
New Mexico State University
Jason Mendoza, PhD principal investigator
Fred Hutch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Kids + in people with Health Behavior, run by New Mexico State University 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 1 inclusion and 1 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 27 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
After-School Student Questionnaire (ASSQ) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563506, which also lists 6 linked publications.
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 27 Aug 2025.