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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR016255-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iAmHealthy | Experimental | Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. |
|
| Control | Active Comparator | Participants randomized to this group receive comparable content delivered via a newsletter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iAmHealthy Healthy Lifestyles Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann M Davis, PhD, MPH | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40440117 | Derived | 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. | |
| 35818033 | Derived | Forseth 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. |
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Of the 501 children assessed for eligibility, 148 were eligible, consented, and completed baseline measures, each of whom had a parent/caregiver participate with them.
Participants were recruited across 18 rural schools between 2017 and 2020.
| ID | Title | Description |
|---|---|---|
| FG000 | iAmHealthy | Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. iAmHealthy Healthy Lifestyles Program: 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. |
| FG001 | Control | Participants randomized to this group receive comparable content delivered via a newsletter. Newsletter: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data collection was focused on child participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | iAmHealthy | Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. iAmHealthy Healthy Lifestyles Program: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Six children in the iAmHealthy group and four children in the Control group dropped out or did not complete the height/weight measure at Month 8. | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 8 |
|
20 months
Parents and children were both considered enrolled. No deaths or serious or other adverse events were reported throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iAmHealthy | Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program. iAmHealthy Healthy Lifestyles Program: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Olalde | University of Kansas Medical Center | 913-588-2042 | molalde@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2020 | Mar 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Newsletter | Other | 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. |
|
| 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). | 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. | 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. | 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/ | 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. | Baseline, Month 8, Month 20 |
| Parent Body Mass Index (BMI) | Parent BMI was calculated at three time points. | Baseline, Month 8, Month 20 |
| 30630108 | Derived | Davis 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. |
| Moved Out of District |
|
| BG001 | Control | Participants randomized to this group receive comparable content delivered via a newsletter. Newsletter: 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
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| Sex: Female, Male | Child sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child ethnicity | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Child race/ethnicity | Count of Participants | Participants |
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| Eligible for Free or Reduced Lunch | Count of Participants | Participants |
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| Approximate Total Household Income (Before Taxes) | Count of Participants | Participants |
|
| Body Mass Index Z-Score | 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. | Four participants in the control group did not complete baseline height/weight measurement. | Mean | Standard Deviation | z-score |
|
| Child's Grade | Count of Participants | Participants |
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| OG001 | Control | Participants randomized to this group receive comparable content delivered via a newsletter. Newsletter: 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. |
|
|
| Secondary | 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. | Fourteen children in the iAmHealthy group and five children in the Control group dropped out or did not complete the height/weight measure at Month 20. | Posted | Mean | Standard Deviation | Z-score | Baseline to Month 20 |
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| Secondary | 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). | Participants dropped out between time points or didn't complete all measures. | Posted | Mean | Standard Deviation | minutes per day | Baseline, Month 8, Month 20 |
|
|
|
| Secondary | 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. | Participants dropped out between time points or didn't complete all measures. | Posted | Mean | Standard Deviation | percent of time sedentary | Baseline, Month 8, Month 20 |
|
|
|
| Secondary | 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. | Participants dropped out between time points or didn't complete all measures. | Posted | Mean | Standard Deviation | servings of fruits and vegetables | Baseline, Month 8, Month 20 |
|
|
|
| Secondary | 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/ | Participants dropped out between time points or didn't complete all measures. | Posted | Mean | Standard Deviation | servings of sugar-sweetened beverages | Baseline, Month 8, Month 20 |
|
|
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| Secondary | 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. | Participants dropped out between time points or didn't complete all measures. | Posted | Mean | Standard Deviation | servings of red foods | Baseline, Month 8, Month 20 |
|
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| Secondary | Parent Body Mass Index (BMI) | Parent BMI was calculated at three time points. | Nine parents in the iAmHealthy group and six parents in the Control group dropped out or did not complete the height/weight measure at Month 8. Fourteen parents in the iAmHealthy group and seven parents in the Control group dropped out or did not complete the height/weight measure at Month 20. | Posted | Mean | Standard Deviation | kg/m² | Baseline, Month 8, Month 20 |
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| 0 |
| 128 |
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | Control | Participants randomized to this group receive comparable content delivered via a newsletter. Newsletter: 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. | 0 | 168 | 0 | 168 | 0 | 168 |
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| Unknown or Not Reported |
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| $70,000 to $99,999 |
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| $100,000 to $149,999 |
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| $150,000 or more |
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