Weight LossNCT03304249
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
A study testing iAmHealthy Healthy Lifestyles Program and Newsletter in people with Weight Loss, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- iAmHealthy Healthy Lifestyles Program and Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2017to 20 Jun 2022
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family lives in a rural area (city and/or county population less than 20,000)
- Child Body Mass Index (BMI) >85th and <99th percentile
- Child in 2nd thru 4th grade
- Child and Parent speak English
- Family is available at times intervention is offered
Who cannot join
- Child has physical limitation or receives an injury which significantly limits physical mobility
- Child has significant medical issue
- Child and Parents have significant developmental delay or cognitive impairment
- Child has a sibling who has already enrolled in the program
- Family moves to a non-participating school
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.
Read the detailed description
This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school.
The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.
- Conditions
- Weight Loss
- Being tested
- iAmHealthy Healthy Lifestyles Program, Newsletter
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iAmHealthy Healthy Lifestyles ProgramBehavioural
iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.
NewsletterOther
Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.
| Study group | Role | What they receive |
|---|---|---|
| iAmHealthy | Experimental | Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. Receives: Behavioral: iAmHealthy Healthy Lifestyles Program |
| Control | Active comparator | Participants randomized to this group receive comparable content delivered via a newsletter. Receives: Other: Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
Measured: Baseline to Month 8
Secondary outcomes (7)
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
Measured: Baseline to Month 20
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).
Measured: Baseline, Month 8, Month 20
Physical Activity - % Time in Sedentary Activity
Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
Measured: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Measured: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
Measured: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Measured: Baseline, Month 8, Month 20
Parent Body Mass Index (BMI)
Parent BMI was calculated at three time points.
Measured: Baseline, Month 8, Month 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start13 Oct 2017
- Primary completion30 Nov 2021
- Study completion20 Jun 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ann M Davis, PhD, MPH, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304249
- Sponsor's protocol ID
- iAmHealthy 2
- Other IDs
- R01NR016255-01A1
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2017
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lancaster B, Goldenberg E, Trofimoff AS, Dai Y, Forseth B, Romine RS, Fleming K, Davis A. Mental health outcomes of a pediatric-focused obesity randomized control trial in rural communities. Health Psychol. 2025 Dec;44(12):1095-1104. doi: 10.1037/hea0001518. Epub 2025 May 29.
PubMed 40440117Forseth B, Davis AM, Bakula DM, Murray M, Dean K, Swinburne Romine RE, Fleming K. Validation of remote height and weight assessment in a rural randomized clinical trial. BMC Med Res Methodol. 2022 Jul 11;22(1):185. doi: 10.1186/s12874-022-01669-8.
PubMed 35818033Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.
PubMed 30630108
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
- ClinicalTrials.gov ID
- NCT03304249
- Acronym / sponsor ID
- iAmHealthy 2
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.
Detailed description
This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school.
The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iAmHealthy | Experimental | Behavioral: iAmHealthy Healthy Lifestyles ProgramParticipants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. |
| Control | Active comparator | Other: NewsletterParticipants randomized to this group receive comparable content delivered via a newsletter. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Family lives in a rural area (city and/or county population less than 20,000)
- Child Body Mass Index (BMI) >85th and <99th percentile
- Child in 2nd thru 4th grade
- Child and Parent speak English
- Family is available at times intervention is offered
Key exclusion criteria (5 listed)
- Child has physical limitation or receives an injury which significantly limits physical mobility
- Child has significant medical issue
- Child and Parents have significant developmental delay or cognitive impairment
- Child has a sibling who has already enrolled in the program
- Family moves to a non-participating school
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 |
|---|---|---|
| iAmHealthy Healthy Lifestyles ProgramiAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions. | Behavioural | iAmHealthy |
| NewsletterWeight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months. | Other | Control |
Primary outcome
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Time frame: Baseline to Month 8
Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = [(BMI/M)^L - 1] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
7 secondary outcomes
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Time frame: Baseline to Month 20
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Time frame: Baseline, Month 8, Month 20
Physical Activity - % Time in Sedentary Activity
Time frame: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Time frame: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Time frame: Baseline, Month 8, Month 20
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Time frame: Baseline, Month 8, Month 20
Parent Body Mass Index (BMI)
Time frame: Baseline, Month 8, Month 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40440117Lancaster B, Goldenberg E, Trofimoff AS, Dai Y, Forseth B, Romine RS, Fleming K, Davis A. Mental health outcomes of a pediatric-focused obesity randomized control trial in rural communities. Health Psychol. 2025 Dec;44(12):1095-1104. doi: 10.1037/hea0001518. Epub 2025 May 29.
- Derived from this study: PubMed 35818033Forseth B, Davis AM, Bakula DM, Murray M, Dean K, Swinburne Romine RE, Fleming K. Validation of remote height and weight assessment in a rural randomized clinical trial. BMC Med Res Methodol. 2022 Jul 11;22(1):185. doi: 10.1186/s12874-022-01669-8.
- Derived from this study: PubMed 30630108Davis AM, Beaver G, Dreyer Gillette M, Nelson EL, Fleming K, Swinburne Romine R, Sullivan DK, Lee R, Pettee Gabriel K, Dean K, Murray M, Faith M. iAmHealthy: Rationale, design and application of a family-based mHealth pediatric obesity intervention for rural children. Contemp Clin Trials. 2019 Mar;78:20-26. doi: 10.1016/j.cct.2019.01.001. Epub 2019 Jan 7.
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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.
Ann M Davis, PhD, MPH principal investigator
University of Kansas Medical 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 iAmHealthy Healthy Lifestyles Program and Newsletter in people with Weight Loss, run by University of Kansas Medical 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 5 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 13 Sep 2023. 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 13 Sep 2023). 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 Body Mass Index Z-score (BMIz) at Baseline and Month 8 (time frame: Baseline to Month 8). 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 NCT03304249, which also lists 3 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 13 Sep 2023.