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
Among 17 studies in Weight Loss by University of Kansas Medical Center — 4 open to participants now, 5 under way, none of them phase 3. Weight Loss · University of Kansas Medical Center.
Among the 17 studies in Weight Loss by University of Kansas Medical Center, this one is the 4th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2017, is one of 16 with no phase, and was the 6th registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →4 of the 17 studies in Weight Loss by University of Kansas Medical Center are open now, in 1 country. Recruiting first, the newest first:
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
University of Kansas Medical Center · Sites in United States
By country, each count listing its studies:
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.
This study: 5 Years to 10 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2017.
This study's enrollment of 296 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 145 across the 16 interventional studies, 52 across the 1 observational. Of the 12 that completed or were terminated, 6 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
1 of the studies in Weight Loss by University of Kansas Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06668259University of Kansas Medical CenterIntensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention | 2027-02-28 |
Among the 17 studies in Weight Loss by University of Kansas Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Nov 2021, 49 months.
Results were first posted in Sep 2023, 1 year 9 months after primary completion.
Of 670 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 49 months is above that.
Counting every sponsor, half of 729 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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