An interventional study of iAmHealthy Healthy Lifestyles Program and Newsletter in Weight Loss, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Participants randomized to this arm receive the iAmHealthy Healthy Lifestyles Program.
Behavioral: iAmHealthy Healthy Lifestyles Program
Participants randomized to this group receive comparable content delivered via a newsletter.
Other: Newsletter
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.
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.
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.
Time frame: Baseline to Month 8
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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/
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)
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Time frame: Baseline, Month 8, Month 20
Parent Body Mass Index (BMI)
Parent BMI was calculated at three time points.
Time frame: Baseline, Month 8, Month 20
Participants were recruited across 18 rural schools between 2017 and 2020.
| Milestone | iAmHealthy | Control |
|---|---|---|
| Started | 128 | 168 |
| 8 months | 118 | 166 |
| Completed | 104 | 154 |
| Not completed | 24 | 14 |
| Withdrew: Lost to follow-up | 8 | 10 |
| Withdrew: Withdrawal by subject | 12 | 2 |
| Withdrew: Moved out of district | 4 | 2 |
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.
| Z-score | iAmHealthy | Control |
|---|---|---|
| Baseline | 1.78 ± 0.54 | 1.92 ± 0.47 |
| Month 8 | 1.78 ± 0.54 | 1.96 ± 0.48 |
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.
| Z-score | iAmHealthy | Control |
|---|---|---|
| Baseline | 1.78 ± 0.54 | 1.92 ± 0.47 |
| Month 20 | 1.82 ± 0.50 | 2.04 ± 0.46 |
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).
| minutes per day | iAmHealthy | Control |
|---|---|---|
| Baseline | 51.14 ± 22.72 | 52.95 ± 18.99 |
| Month 8 | 47.16 ± 18.82 | 49.07 ± 22.49 |
| Month 20 | 44.86 ± 18.81 | 41.37 ± 18.57 |
Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
| percent of time sedentary | iAmHealthy | Control |
|---|---|---|
| Baseline | 59.14 ± 7.12 | 56.57 ± 6.60 |
| Month 8 | 61.14 ± 8.55 | 59.62 ± 9.00 |
| Month 20 | 63.89 ± 8.09 | 63.28 ± 8.11 |
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
| servings of fruits and vegetables | iAmHealthy | Control |
|---|---|---|
| Baseline | 3.27 ± 1.66 | 2.68 ± 1.38 |
| Month 8 | 3.04 ± 1.68 | 2.45 ± 1.41 |
| Month 20 | 2.89 ± 1.58 | 2.58 ± 1.16 |
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
| servings of sugar-sweetened beverages | iAmHealthy | Control |
|---|---|---|
| Baseline | 1.19 ± 0.89 | 1.14 ± 0.99 |
| Month 8 | 0.75 ± 0.66 | 1.08 ± 0.89 |
| Month 20 | 0.93 ± 0.84 | 1.21 ± 1.06 |
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
| servings of red foods | iAmHealthy | Control |
|---|---|---|
| Baseline | 6.64 ± 2.43 | 7.40 ± 3.91 |
| Month 8 | 5.12 ± 1.89 | 6.28 ± 2.28 |
| Month 20 | 5.69 ± 2.00 | 6.89 ± 2.31 |
Parent BMI was calculated at three time points.
| kg/m² | iAmHealthy | Control |
|---|---|---|
| Baseline | 35.83 ± 9.14 | 33.69 ± 8.81 |
| Month 8 | 35.94 ± 9.73 | 33.79 ± 9.32 |
| Month 20 | 35.23 ± 9.03 | 34.31 ± 9.53 |
Collected over 20 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iAmHealthy | 0/128 (0%) | 0/128 (0%) | 0/128 (0%) |
| Control | 0/168 (0%) | 0/168 (0%) | 0/168 (0%) |
Baseline data collection was focused on child participants.
| Age, Continuous(years) | iAmHealthy | Control | Total |
|---|---|---|---|
| Mean | 8.9880 ± 0.8859 | 8.8880 ± 0.8402 | 8.9313 ± 0.8587 |
| Sex: Female, Male(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| Female | 38 | 46 | 84 |
| Male | 26 | 38 | 64 |
| Ethnicity (NIH/OMB)(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 14 | 20 |
| Not Hispanic or Latino | 58 | 70 | 128 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| White | 55 | 74 | 129 |
| Native American | 0 | 1 | 1 |
| Asian/Pacific Islander | 1 | 0 | 1 |
| Other | 1 | 1 | 2 |
| Biracial | 7 | 8 | 15 |
| Eligible for Free or Reduced Lunch(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| Eligible | 36 | 38 | 74 |
| Not Eligible | 28 | 46 | 74 |
| Approximate Total Household Income (Before Taxes)(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| Less than $30,000 | 11 | 24 | 35 |
| $30,000 to $69,999 | 27 | 25 | 52 |
| $70,000 to $99,999 | 11 | 25 | 36 |
| $100,000 to $149,999 | 14 | 7 | 21 |
| $150,000 or more | 1 | 3 | 4 |
| Body Mass Index Z-Score(z-score) | iAmHealthy | Control | Total |
|---|---|---|---|
| Mean | 1.7767 ± 0.5406 | 1.9209 ± 0.4705 | 1.8568 ± 0.5062 |
| Child's Grade(Participants) | iAmHealthy | Control | Total |
|---|---|---|---|
| 2 | 18 | 22 | 40 |
| 3 | 20 | 33 | 53 |
| 4 | 26 | 29 | 55 |
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University of Kansas Medical Center