Childhood ObesityNCT03297541

Healthy Kids I-PAL

A study testing m-health approach in people with Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents. Read more about this study

Who is it for?: Ages 5 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Childhood Obesity
What is being tested?: m-health approach
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2017to 12 Dec 2017
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 5 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Have at least one participating parent
Be physically capable of exercise
Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer
Have a smart phone
Be willing to use the smartphone for the mHealth intervention

Who cannot join

Significant cardiovascular disease or disorders via self-report from parent
Other significant medical problems that would prevent them from engaging in regular physical activity.

Trial locations and contacts

1 site in 1 country.

United States1 site

Southeastern Louisiana University
Hammond, Louisiana, 70402

Other trials in United States

About this study

Official title: Healthy Kids at I-PAL (Interactive Physical Activity Lab)

Conditions: Childhood Obesity
Being tested: m-health approach
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

m-health approachBehavioural
Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981). Anthropometric and demographic data collected on children in the dyad only.

Study groups in NCT03297541
Study group	Role	What they receive
m-health approach	Experimental	All dyads will receive the m-health approach. Receives: Behavioral: m-health approach

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Acceptability of the mHealth Approach
Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability.
Measured: 13 Weeks

Secondary outcomes (1)

BMI Z-score Change
Objectively measured height and weight were compared against the normative values for age (months) and sex according to the CDC growth charts. A z-score is assigned, with 0 representing the population mean. A positive z-score indicates a BMI above the population mean (higher relative weight), whereas a negative z-score is below the population mean (lower relative weight). For the change score, the post BMI z-score measured at week 14-16 was subtracted from the baseline BMI z-score. For the change score, a positive value indicates an increase in relative weight, whereas a negative value indicates a reduction in relative weight.
Measured: Week 0 to Week 14-16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201712 Dec 2017

First posted29 Sep 2017
Study start5 Sep 2017
Primary completion12 Dec 2017
Study completion12 Dec 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Childhood ObesityStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03297541
Sponsor's protocol ID: PBRC 2016-009
Status last verified: Nov 2024
First submitted: 18 Sep 2017
Last updated: 7 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.
PubMed 33410760

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Healthy Kids at I-PAL (Interactive Physical Activity Lab)
ClinicalTrials.gov ID: NCT03297541
Acronym / sponsor ID: PBRC 2016-009
Conditions: Childhood Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Collaborators: Southeastern Louisiana University
Study start: 5 Sep 2017 (actual)
Primary completion: 12 Dec 2017 (actual)
Study completion: 12 Dec 2017 (actual)
First posted: 29 Sep 2017 (actual)
Results: Posted 7 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
m-health approach	Experimental	Behavioral: m-health approachAll dyads will receive the m-health approach.

Who may qualify

Ages: 5 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Have at least one participating parent
Be physically capable of exercise
Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer
Have a smart phone
Be willing to use the smartphone for the mHealth intervention

Key exclusion criteria (2 listed)

Significant cardiovascular disease or disorders via self-report from parent
Other significant medical problems that would prevent them from engaging in regular physical activity.

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
m-health approachParent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981). Anthropometric and demographic data collected on children in the dyad only.	Behavioural	m-health approach

Primary outcome

Child Acceptability of the mHealth Approach
Time frame: 13 Weeks
Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability.

1 secondary outcome

BMI Z-score Change
Time frame: Week 0 to Week 14-16

Results and safety

Results posted to the registry on 7 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M-health Approach	10	10

Primary outcome: Child Acceptability of the mHealth Approach

Time frame: 13 Weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	M-health Approach n = 10
Value	3.8 (.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 16 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Child Participants in the Dyads	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Parent Participants in the Dyads	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): A limitation of these studies is the one-arm design without a control or comparator and the need for further verification in a larger randomized controlled trial. It is possible that BMIz fluctuations were influenced by maturation bias or regression to the mean, though the observed effect size was similar to prior interventions. Another limitation is the use of BMIz to examine change, as researchers have identified concerns with z-score for children with a BMI above the 97th percentile.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33410760Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.
Individual participant dataSharing planned: No

Related trials for Childhood Obesity

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
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Not yet recruiting
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Leukemia, Pediatric Acute Lymphoblastic Leukemia

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.

Amanda Staiano, PhD principal investigator

Pennington Biomedical Research Center

Corby Martin, PhD principal investigator

Pennington Biomedical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing m-health approach in people with Childhood Obesity, run by Pennington Biomedical Research Center at 1 site 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 5 inclusion and 2 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 7 Nov 2024). 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?

Child Acceptability of the mHealth Approach (time frame: 13 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 NCT03297541, which also lists 1 linked publication.

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 7 Nov 2024.