Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03304249

Enrollment

296

Registered

2017-10-06

Start date

2017-10-13

Completion date

2022-06-20

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Brief 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.

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.

Interventions

BEHAVIORALiAmHealthy 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.

OTHERNewsletter

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 10 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	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.

Secondary

Measure	Time frame	Description
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day	Baseline, Month 8, Month 20	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).
Physical Activity - % Time in Sedentary Activity	Baseline, Month 8, Month 20	Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Baseline to 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.
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Red Foods (Foods High in Sugar and/or Fat)	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.
Parent Body Mass Index (BMI)	Baseline, Month 8, Month 20	Parent BMI was calculated at three time points.
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages	Baseline, Month 8, Month 20	The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/

Countries

United States

Participant flow

Recruitment details

Participants were recruited across 18 rural schools between 2017 and 2020.

Pre-assignment details

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 by arm

Arm	Count
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.	64
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.	84
Total	148

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	8	10
Overall Study	Moved Out of District	4	2
Overall Study	Withdrawal by Subject	12	2

Baseline characteristics

Characteristic	iAmHealthy	Control	Total
Age, Continuous	8.9880 years STANDARD_DEVIATION 0.8859	8.8880 years STANDARD_DEVIATION 0.8402	8.9313 years STANDARD_DEVIATION 0.8587
Approximate Total Household Income (Before Taxes) $100,000 to $149,999	14 Participants	7 Participants	21 Participants
Approximate Total Household Income (Before Taxes) $150,000 or more	1 Participants	3 Participants	4 Participants
Approximate Total Household Income (Before Taxes) $30,000 to $69,999	27 Participants	25 Participants	52 Participants
Approximate Total Household Income (Before Taxes) $70,000 to $99,999	11 Participants	25 Participants	36 Participants
Approximate Total Household Income (Before Taxes) Less than $30,000	11 Participants	24 Participants	35 Participants
Body Mass Index Z-Score	1.7767 z-score STANDARD_DEVIATION 0.5406	1.9209 z-score STANDARD_DEVIATION 0.4705	1.8568 z-score STANDARD_DEVIATION 0.5062
Child's Grade 2	18 Participants	22 Participants	40 Participants
Child's Grade 3	20 Participants	33 Participants	53 Participants
Child's Grade 4	26 Participants	29 Participants	55 Participants
Eligible for Free or Reduced Lunch Eligible	36 Participants	38 Participants	74 Participants
Eligible for Free or Reduced Lunch Not Eligible	28 Participants	46 Participants	74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	14 Participants	20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants	70 Participants	128 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Biracial	7 Participants	8 Participants	15 Participants
Race/Ethnicity, Customized Native American	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Other	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized White	55 Participants	74 Participants	129 Participants
Sex: Female, Male Female	38 Participants	46 Participants	84 Participants
Sex: Female, Male Male	26 Participants	38 Participants	64 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 128	0 / 168
other Total, other adverse events	0 / 128	0 / 168
serious Total, serious adverse events	0 / 128	0 / 168

Outcome results

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.

Time frame: Baseline to Month 8

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
iAmHealthy	Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	Baseline	1.78 Z-score	Standard Deviation 0.54
iAmHealthy	Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	Month 8	1.78 Z-score	Standard Deviation 0.54
Control	Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	Baseline	1.92 Z-score	Standard Deviation 0.47
Control	Child Body Mass Index Z-score (BMIz) at Baseline and Month 8	Month 8	1.96 Z-score	Standard Deviation 0.48

Secondary

Child Body Mass Index Z-score (BMIz) at Baseline and Month 20

Time frame: Baseline to Month 20

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
iAmHealthy	Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Baseline	1.78 Z-score	Standard Deviation 0.54
iAmHealthy	Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Month 20	1.82 Z-score	Standard Deviation 0.5
Control	Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Baseline	1.92 Z-score	Standard Deviation 0.47
Control	Child Body Mass Index Z-score (BMIz) at Baseline and Month 20	Month 20	2.04 Z-score	Standard Deviation 0.46

Secondary