Trial Outcomes & Findings for Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention (NCT NCT03304249)
NCT ID: NCT03304249
Last Updated: 2023-09-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
296 participants
Primary outcome timeframe
Baseline to Month 8
Results posted on
2023-09-13
Participant Flow
Participants were recruited across 18 rural schools between 2017 and 2020.
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.
Unit of analysis: schools
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
128 9
|
168 9
|
|
Overall Study
8 Months
|
118 9
|
166 9
|
|
Overall Study
COMPLETED
|
104 9
|
154 9
|
|
Overall Study
NOT COMPLETED
|
24 0
|
14 0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
12
|
2
|
|
Overall Study
Moved Out of District
|
4
|
2
|
Baseline Characteristics
Four participants in the control group did not complete baseline height/weight measurement.
Baseline characteristics by cohort
| Measure |
iAmHealthy
n=64 Participants
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.
|
Control
n=84 Participants
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.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.9880 years
STANDARD_DEVIATION 0.8859 • n=64 Participants
|
8.8880 years
STANDARD_DEVIATION 0.8402 • n=84 Participants
|
8.9313 years
STANDARD_DEVIATION 0.8587 • n=148 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=64 Participants
|
46 Participants
n=84 Participants
|
84 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=64 Participants
|
38 Participants
n=84 Participants
|
64 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=64 Participants
|
14 Participants
n=84 Participants
|
20 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=64 Participants
|
70 Participants
n=84 Participants
|
128 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=64 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=64 Participants
|
74 Participants
n=84 Participants
|
129 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=64 Participants
|
1 Participants
n=84 Participants
|
1 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 Participants
n=64 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=64 Participants
|
1 Participants
n=84 Participants
|
2 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
7 Participants
n=64 Participants
|
8 Participants
n=84 Participants
|
15 Participants
n=148 Participants
|
|
Eligible for Free or Reduced Lunch
Eligible
|
36 Participants
n=64 Participants
|
38 Participants
n=84 Participants
|
74 Participants
n=148 Participants
|
|
Eligible for Free or Reduced Lunch
Not Eligible
|
28 Participants
n=64 Participants
|
46 Participants
n=84 Participants
|
74 Participants
n=148 Participants
|
|
Approximate Total Household Income (Before Taxes)
Less than $30,000
|
11 Participants
n=64 Participants
|
24 Participants
n=84 Participants
|
35 Participants
n=148 Participants
|
|
Approximate Total Household Income (Before Taxes)
$30,000 to $69,999
|
27 Participants
n=64 Participants
|
25 Participants
n=84 Participants
|
52 Participants
n=148 Participants
|
|
Approximate Total Household Income (Before Taxes)
$70,000 to $99,999
|
11 Participants
n=64 Participants
|
25 Participants
n=84 Participants
|
36 Participants
n=148 Participants
|
|
Approximate Total Household Income (Before Taxes)
$100,000 to $149,999
|
14 Participants
n=64 Participants
|
7 Participants
n=84 Participants
|
21 Participants
n=148 Participants
|
|
Approximate Total Household Income (Before Taxes)
$150,000 or more
|
1 Participants
n=64 Participants
|
3 Participants
n=84 Participants
|
4 Participants
n=148 Participants
|
|
Body Mass Index Z-Score
|
1.7767 z-score
STANDARD_DEVIATION 0.5406 • n=64 Participants • Four participants in the control group did not complete baseline height/weight measurement.
|
1.9209 z-score
STANDARD_DEVIATION 0.4705 • n=80 Participants • Four participants in the control group did not complete baseline height/weight measurement.
|
1.8568 z-score
STANDARD_DEVIATION 0.5062 • n=144 Participants • Four participants in the control group did not complete baseline height/weight measurement.
|
|
Child's Grade
2
|
18 Participants
n=64 Participants
|
22 Participants
n=84 Participants
|
40 Participants
n=148 Participants
|
|
Child's Grade
3
|
20 Participants
n=64 Participants
|
33 Participants
n=84 Participants
|
53 Participants
n=148 Participants
|
|
Child's Grade
4
|
26 Participants
n=64 Participants
|
29 Participants
n=84 Participants
|
55 Participants
n=148 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 8Population: 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.
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.
Outcome measures
| Measure |
iAmHealthy
n=64 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Baseline
|
1.78 Z-score
Standard Deviation 0.54
|
1.92 Z-score
Standard Deviation 0.47
|
|
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
Month 8
|
1.78 Z-score
Standard Deviation 0.54
|
1.96 Z-score
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to Month 20Population: 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.
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.
Outcome measures
| Measure |
iAmHealthy
n=64 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Baseline
|
1.78 Z-score
Standard Deviation 0.54
|
1.92 Z-score
Standard Deviation 0.47
|
|
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20
Month 20
|
1.82 Z-score
Standard Deviation 0.50
|
2.04 Z-score
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: Participants dropped out between time points or didn't complete all measures.
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).
Outcome measures
| Measure |
iAmHealthy
n=61 Participants
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.
|
Control
n=82 Participants
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.
|
|---|---|---|
|
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Baseline
|
51.14 minutes per day
Standard Deviation 22.72
|
52.95 minutes per day
Standard Deviation 18.99
|
|
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Month 8
|
47.16 minutes per day
Standard Deviation 18.82
|
49.07 minutes per day
Standard Deviation 22.49
|
|
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day
Month 20
|
44.86 minutes per day
Standard Deviation 18.81
|
41.37 minutes per day
Standard Deviation 18.57
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: Participants dropped out between time points or didn't complete all measures.
Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
Outcome measures
| Measure |
iAmHealthy
n=61 Participants
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.
|
Control
n=82 Participants
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.
|
|---|---|---|
|
Physical Activity - % Time in Sedentary Activity
Baseline
|
59.14 percent of time sedentary
Standard Deviation 7.12
|
56.57 percent of time sedentary
Standard Deviation 6.60
|
|
Physical Activity - % Time in Sedentary Activity
Month 8
|
61.14 percent of time sedentary
Standard Deviation 8.55
|
59.62 percent of time sedentary
Standard Deviation 9.00
|
|
Physical Activity - % Time in Sedentary Activity
Month 20
|
63.89 percent of time sedentary
Standard Deviation 8.09
|
63.28 percent of time sedentary
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: Participants dropped out between time points or didn't complete all measures.
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Outcome measures
| Measure |
iAmHealthy
n=61 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Baseline
|
3.27 servings of fruits and vegetables
Standard Deviation 1.66
|
2.68 servings of fruits and vegetables
Standard Deviation 1.38
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Month 8
|
3.04 servings of fruits and vegetables
Standard Deviation 1.68
|
2.45 servings of fruits and vegetables
Standard Deviation 1.41
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables
Month 20
|
2.89 servings of fruits and vegetables
Standard Deviation 1.58
|
2.58 servings of fruits and vegetables
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: Participants dropped out between time points or didn't complete all measures.
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/
Outcome measures
| Measure |
iAmHealthy
n=61 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Baseline
|
1.19 servings of sugar-sweetened beverages
Standard Deviation 0.89
|
1.14 servings of sugar-sweetened beverages
Standard Deviation 0.99
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Month 8
|
0.75 servings of sugar-sweetened beverages
Standard Deviation 0.66
|
1.08 servings of sugar-sweetened beverages
Standard Deviation 0.89
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages
Month 20
|
0.93 servings of sugar-sweetened beverages
Standard Deviation 0.84
|
1.21 servings of sugar-sweetened beverages
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: Participants dropped out between time points or didn't complete all measures.
The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Outcome measures
| Measure |
iAmHealthy
n=61 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Month 20
|
5.69 servings of red foods
Standard Deviation 2.00
|
6.89 servings of red foods
Standard Deviation 2.31
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Baseline
|
6.64 servings of red foods
Standard Deviation 2.43
|
7.40 servings of red foods
Standard Deviation 3.91
|
|
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)
Month 8
|
5.12 servings of red foods
Standard Deviation 1.89
|
6.28 servings of red foods
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline, Month 8, Month 20Population: 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.
Parent BMI was calculated at three time points.
Outcome measures
| Measure |
iAmHealthy
n=63 Participants
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.
|
Control
n=80 Participants
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.
|
|---|---|---|
|
Parent Body Mass Index (BMI)
Baseline
|
35.83 kg/m²
Standard Deviation 9.14
|
33.69 kg/m²
Standard Deviation 8.81
|
|
Parent Body Mass Index (BMI)
Month 8
|
35.94 kg/m²
Standard Deviation 9.73
|
33.79 kg/m²
Standard Deviation 9.32
|
|
Parent Body Mass Index (BMI)
Month 20
|
35.23 kg/m²
Standard Deviation 9.03
|
34.31 kg/m²
Standard Deviation 9.53
|
Adverse Events
iAmHealthy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place