Trial Outcomes & Findings for Feasibility Trial of the iAMHealthy Intervention (NCT NCT04142034)
NCT ID: NCT04142034
Last Updated: 2022-09-13
Results Overview
Measure participant recruitment rate for both recruitment options
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
1 month for each recruitment option plus a 1 month catch-up period
Results posted on
2022-09-13
Participant Flow
Participants (children) were recruited through two approached: consecutive recruitment method or traditional recruitment method. The data shown for these methods is the number of individuals approached about the clinical trial and the number who were successfully recruited into the clinical trial and randomized into one of the two intervention arms Caregivers are not participant but are evaluated for efficacy in terms of body mass index
Participant milestones
| Measure |
Consecutive Recruitment Method
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
iAmHealthy + Newsletter Behavorial Intervention
This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.
the iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm
Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:
* usual care at their clinic for all issues, including overweight and obesity;
* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);
* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;
* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician
|
NewsLetter Intervention
This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.
Newsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
|
|---|---|---|---|---|
|
Recruitment Period
STARTED
|
535
|
23
|
0
|
0
|
|
Recruitment Period
COMPLETED
|
99
|
5
|
0
|
0
|
|
Recruitment Period
NOT COMPLETED
|
436
|
18
|
0
|
0
|
|
Intervention Period
STARTED
|
0
|
0
|
52
|
52
|
|
Intervention Period
COMPLETED
|
0
|
0
|
45
|
50
|
|
Intervention Period
NOT COMPLETED
|
0
|
0
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
Baseline characteristics by cohort
| Measure |
iAmHealthy + Newsletter Behavorial Intervention
n=52 Participants
This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.
the iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm
Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:
* usual care at their clinic for all issues, including overweight and obesity;
* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);
* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;
* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician
|
NewsLetter Intervention
n=52 Participants
This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.
Newsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.4 years
STANDARD_DEVIATION 1.7 • n=52 Participants
|
9.2 years
STANDARD_DEVIATION 1.7 • n=52 Participants
|
9.3 years
STANDARD_DEVIATION 1.7 • n=104 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=52 Participants
|
26 Participants
n=52 Participants
|
58 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=52 Participants
|
26 Participants
n=52 Participants
|
46 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=52 Participants
|
3 Participants
n=52 Participants
|
8 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=52 Participants
|
49 Participants
n=52 Participants
|
94 Participants
n=104 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=52 Participants
|
0 Participants
n=52 Participants
|
2 Participants
n=104 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=52 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=52 Participants
|
8 Participants
n=52 Participants
|
24 Participants
n=104 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=52 Participants
|
35 Participants
n=52 Participants
|
68 Participants
n=104 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=52 Participants
|
8 Participants
n=52 Participants
|
11 Participants
n=104 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=104 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=52 Participants
|
52 participants
n=52 Participants
|
104 participants
n=104 Participants
|
|
Child body mass index
|
26.15 kg/m^2
STANDARD_DEVIATION 5.52 • n=34 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
23.04 kg/m^2
STANDARD_DEVIATION 3.71 • n=39 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
24.48 kg/m^2
STANDARD_DEVIATION 4.87 • n=73 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
|
Child body mass index adjusted for age and sex
|
2.56 z-score
STANDARD_DEVIATION 1.41 • n=34 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
1.86 z-score
STANDARD_DEVIATION 0.55 • n=39 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
2.19 z-score
STANDARD_DEVIATION 1.09 • n=73 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
|
Caregiver body mass index
|
35.54 kg/m^2
STANDARD_DEVIATION 9.93 • n=34 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
34.97 kg/m^2
STANDARD_DEVIATION 8.48 • n=39 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
35.24 kg/m^2
STANDARD_DEVIATION 9.12 • n=73 Participants • The participant population excludes participants from a site with data quality issues for height and weight, and participants who did not have post-intervention measurements
|
|
Daily sweetened drink servings
|
1.16 daily sweetened drink servings
STANDARD_DEVIATION 1.30 • n=43 Participants • Analysis population includes participants who have post-intervention measurements
|
1.18 daily sweetened drink servings
STANDARD_DEVIATION 1.20 • n=50 Participants • Analysis population includes participants who have post-intervention measurements
|
1.17 daily sweetened drink servings
STANDARD_DEVIATION 1.24 • n=93 Participants • Analysis population includes participants who have post-intervention measurements
|
|
Daily fruit and vegetable servings
|
2.42 daily fruit and vegetable servings
STANDARD_DEVIATION 1.21 • n=43 Participants • Analysis population is participants with post-intervention measures
|
2.62 daily fruit and vegetable servings
STANDARD_DEVIATION 1.43 • n=50 Participants • Analysis population is participants with post-intervention measures
|
2.53 daily fruit and vegetable servings
STANDARD_DEVIATION 1.33 • n=93 Participants • Analysis population is participants with post-intervention measures
|
|
Daily servings of red foods
|
6.30 daily servings of red foods
STANDARD_DEVIATION 1.83 • n=43 Participants • Analysis population includes participants with post-intervention measurements
|
6.39 daily servings of red foods
STANDARD_DEVIATION 2.11 • n=50 Participants • Analysis population includes participants with post-intervention measurements
|
6.35 daily servings of red foods
STANDARD_DEVIATION 1.97 • n=93 Participants • Analysis population includes participants with post-intervention measurements
|
|
Average daily minutes of moderate to vigorous physical activity
|
38.92 daily minutes of MVPA
STANDARD_DEVIATION 36.92 • n=27 Participants • Analysis population excluded participants from a site where there were concerns regarding actigraph data quality, and participants who did not have post-intervention measures
|
55.46 daily minutes of MVPA
STANDARD_DEVIATION 62.70 • n=31 Participants • Analysis population excluded participants from a site where there were concerns regarding actigraph data quality, and participants who did not have post-intervention measures
|
47.76 daily minutes of MVPA
STANDARD_DEVIATION 52.54 • n=58 Participants • Analysis population excluded participants from a site where there were concerns regarding actigraph data quality, and participants who did not have post-intervention measures
|
|
MVPA (%)
|
5.15 percentage of time
STANDARD_DEVIATION 2.58 • n=21 Participants • Analysis population excludes participants from a site where there were data quality issues from the actigraph, and participants without post-intervention measurements
|
6.13 percentage of time
STANDARD_DEVIATION 3.45 • n=27 Participants • Analysis population excludes participants from a site where there were data quality issues from the actigraph, and participants without post-intervention measurements
|
5.70 percentage of time
STANDARD_DEVIATION 3.11 • n=48 Participants • Analysis population excludes participants from a site where there were data quality issues from the actigraph, and participants without post-intervention measurements
|
PRIMARY outcome
Timeframe: 1 month for each recruitment option plus a 1 month catch-up periodPopulation: Potential study participants who were approached about the study using one of the two recruitment methods
Measure participant recruitment rate for both recruitment options
Outcome measures
| Measure |
Consecutive Recruitment Method
n=535 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=23 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Participant Recruitment Rate
|
99 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study participants who were randomized to one of the two behavioral interventions
Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=52 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=52 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Participant Retention
|
45 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who had child BMI measurements at baseline and at the end of the intervention period and were at sites that did not have data quality issues with height and weight measurements.
This measure is derived from subtracting the child body mass index (BMI) taken at baseline from the child BMI taken at the end of the intervention period
Outcome measures
| Measure |
Consecutive Recruitment Method
n=34 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=39 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Child Body Mass Index From Baseline to Post-intervention
|
0.32 kg/m^2
Standard Deviation 2.42
|
1.25 kg/m^2
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who had child BMI adjusted for age and sex measurements at baseline and at the end of the intervention period and were at sites that did not have data quality issues with height and weight measurements.
This measure is derived from subtracting the child BMIz taken at baseline from the child BMIz adjusted for age and sex at the end of the intervention period. The BMIz is the body mass index adjusted for sex and age, and is a z-score normalized for the mean and standard deviation of the body mass index for the child's age and sex. A BMI z-score over 1.96 indicates that the child's body mass index is above the 95th percentile for his/her age.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=34 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=39 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
|
-0.11 z-score
Standard Deviation 0.53
|
0.12 z-score
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who had caregiver BMI measurements at baseline and at the end of the intervention period and were from sites that did not have data quality issues with height and weight measurements.
The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period
Outcome measures
| Measure |
Consecutive Recruitment Method
n=34 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=39 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Caregiver Body Mass Index From Baseline to Post-intervention
|
-0.32 kg/m^2
Standard Deviation 3.19
|
-0.90 kg/m^2
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants for whom data on the daily servings of sweetened drinks consumed was available at baseline and at the end of the intervention period
This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period
Outcome measures
| Measure |
Consecutive Recruitment Method
n=43 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=50 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Daily Servings of Sweetened Drinks
|
0.80 daily servings of sweetened drinks
Standard Deviation 0.72
|
0.81 daily servings of sweetened drinks
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants for whom data on the number of servings of fruits and vegetables consumed daily was available at baseline and at the end of the intervention period
This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period
Outcome measures
| Measure |
Consecutive Recruitment Method
n=43 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=50 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention
|
0.36 Daily fruit/vegetable servings
Standard Deviation 1.91
|
0 Daily fruit/vegetable servings
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants for whom information on the number of daily servings of red food were available at baseline and post-intervention
This measure shows the change in the number of red food servings consumed daily from baseline to after the intervention period. Red foods are defined as those with greater than or equal to 7 grams of fat and/or greater than or equal to 12 grams of sugar per serving.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=43 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=50 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention
|
-0.78 daily red food servings
Standard Deviation 1.95
|
-0.45 daily red food servings
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants for whom baseline and post-intervention measurements of minutes of MVPA were available at baseline and post-intervention and were at sites without data quality issues related to activity monitors.
The number of minutes spent in moderate to vigorous physical activity (MVPA) is measured using an activity monitor worn by the participant. This measure is the change in minutes in MVPA from baseline to after the intervention period
Outcome measures
| Measure |
Consecutive Recruitment Method
n=27 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=31 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention
|
-14.64 daily minutes of MVPA
Standard Deviation 39.88
|
-28.74 daily minutes of MVPA
Standard Deviation 65.61
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants for whom the % of MVPA was available from the activity monitor at baseline and post-intervention and were at sites that did not have data quality issues with the activity monitors.
The denominator for this measure is the number of minutes that the participant is wearing the activity monitor. The % of moderate to vigorous physical time (MVPA) is the percent of that time that the participant is spent in moderate to vigorous physical activity. This measure describes the change in that percent of time from baseline to after intervention.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=21 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=27 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention
|
-0.79 percentage of time
Standard Deviation 2.71
|
-1.60 percentage of time
Standard Deviation 2.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The analysis population is the study participants randomized to the iAmHealthy + Newsletter behavioral intervention who were retained through the 6-month intervention period
Participants who receive at least 80% of the planned intervention (dose) among those participants randomized to the iAmHealthy behavioral intervention arm who are retained through the final measurement.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=45 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention
|
29 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Participants who were randomized to one of the two behavioral interventions
Blinding index as described by Bang (Bang et cl. Assessment of blinding in clinical trials. Control Clin Trials 2004: 25(2):143-156. It ranges from -1 to 1 where a value of 0 indicates fully successful blinding; a value of 1 indicates lack of blinding meaning that individuals were able to correctly identify participants' assigned intervention, and -1 indicates that individuals typically guessed the incorrect assignment.
Outcome measures
| Measure |
Consecutive Recruitment Method
n=52 Participants
Using this recruitment method, clinics will identify potential eligible study participants through their medical records among those that have been seen in the clinic within the past year and those children with upcoming appointments and approach them and their caregivers about enrolling in the study.
Consecutive Recruitment: Recruitment of study participants through identifying potential participants through their medical records
|
Traditional Recruitment Method
n=52 Participants
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Traditional Recruitment: Recruitment of potential participants through flyers and advertisements
|
|---|---|---|
|
Staff Blinding
|
0.12 index
Standard Deviation 0.13
|
0.02 index
Standard Deviation 0.13
|
Adverse Events
iAmHealthy + Newsletter Behavorial Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NewsLetter Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iAmHealthy + Newsletter Behavorial Intervention
n=52 participants at risk
This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor.
the iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm
Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive:
* usual care at their clinic for all issues, including overweight and obesity;
* a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants);
* weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply;
* 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician
|
NewsLetter Intervention
n=52 participants at risk
This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.
Newsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Upper limb
|
1.9%
1/52 • Number of events 1 • 6 months
Using standard definitions of adverse events, adverse events were reported during the intervention period. All-cause mortality, serious and other (not including serious) adverse events were not reporting during the recruitment period for those in the consecutive recruitment or traditional recruitment arms.
|
0.00%
0/52 • 6 months
Using standard definitions of adverse events, adverse events were reported during the intervention period. All-cause mortality, serious and other (not including serious) adverse events were not reporting during the recruitment period for those in the consecutive recruitment or traditional recruitment arms.
|
Additional Information
Jeannette Lee
University of Arkansas for Medical Sciences
Phone: 5015266712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place