iAmHealthy: Feasibility Trial of the iAMHealthy Intervention

• Sponsor: IDeA States Pediatric Clinical Trials Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT04142034
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 104
• Locations: 4
• Arms: 4
• Actual Duration (Months): 13.7
• Patients Per Site: 26
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This research study is being done to find out which of 2 ways works best to get rural participants interested in joining a research study about children who weigh more than is considered healthy. One method researchers will use is the traditional method of reaching out to potential participants. The traditional method includes using flyers, posters, and booklets. The other method will be to target people who might be especially interested in the study. The second method uses medical records to find potential participants who are most likely to qualify for the study. This study is also being done to what works to help keep participants in a study like this.

Another goal of the study is to find out what methods work well to help get and keep children's and caregiver's weight in the healthy range. Researchers also want to see what works well to help children with a high Body Mass Index be more physically active and to eat healthier foods. The test methods researchers will use for this part of the study are (1) newsletters only and (2) newsletters plus online meetings. Participants will be randomly assigned to 1 of the 2 groups (newsletter or newsletter plus meetings.)

The newsletter-only group will receive monthly newsletters about children's health; this group will receive these letters for 6 months. The 'newsletter plus meeting group' will also receive the same monthly newsletter for 6 months. The latter group will also have online meetings with other children and adults as well as a group leader. Those in the 'newsletter plus meeting group' will also individually meet with a dietician.

This study will involve children and one of their caregivers (parent/guardian). The child and caregiver must live in a rural area. The child must be 6 to 11 years old. The child must be considered to have an unhealthy weight (high Body Mass Index). Both the child and caregiver must speak English. Up to 224 children will enter into this study. Participants will be consented through 4 different sites that are part of the IDeA States Pediatric Network.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Rurality	Behavioral: the iAmHealthy Behavioral Intervention; Behavioral: Newsletter only arm; Other: Consecutive Recruitment; Other: Traditional Recruitment	N/A

Detailed Description

Conduct a multisite feasibility trial for the iAmHealthy intervention with two randomized controlled recruitment options (consecutive recruitment and traditional recruitment). We will examine retention, dose, and blinding that will inform the development of a larger, treatment-outcome fully powered randomized controlled trial (RCT) of the iAmHealthy behavioral intervention in the IDeA States Pediatric Clinical Trials Network (ISPCTN).

The study team will perform the iAmHealthy trial will be performed in four ISPCTN site-awardee states. Specifically, the study team will perform the iAmHealthy trial in one clinic per state.

Randomization of recruitment options occurs at the clinic level. Each clinic, in a randomly ordered sequence, will implement two methods of recruitment. Recruitment of Participants, for more detail on the two methods of recruitment.

Randomization of participants into intervention arms will occur at the individual level.

Newsletter-only Intervention Arm

Child/caregiver pairs in the newsletter-only 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.

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.

The iAmHealthy behavioral intervention psychologists/social worker will individualize group sessions and the iAmHealthy behavioral intervention dietician will adapt individual sessions by focusing on local cultural, religious, and ethnic factors relevant to the recommended changes in eating and activity habits. The iAmHealthy behavioral intervention includes 26 contact hours (15 hours of group sessions and 11 hours of individual sessions).

This feasibility trial will provide information toward the implementation of a fully powered, multisite, randomized behavior intervention trial that will compare the effectiveness of the iAmHealthy behavioral intervention to a newsletter-only intervention for the treatment of obesity among rural and underserved children and their primary caregivers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This feasibility trial is a multisite, RCT with two parts. In part 1, sites will be randomized into the order in which two recruitment methods, traditional or consecutive, are used to recruit study participants. In part 2, recruited participants will be randomized to receive a newsletter or newsletter plus the iAmHealthy behavioral intervention.This feasibility trial is a multisite, RCT with two parts. In part 1, sites will be randomized into the order in which two recruitment methods, traditional or consecutive, are used to recruit study participants. In part 2, recruited participants will be randomized to receive a newsletter or newsletter plus the iAmHealthy behavioral intervention.
• Masking: Single (Investigator)
• Masking Description: Each clinics will recruit up to 28 child/caregiver pairs.The site awardee investigators will be blinded. The site awardee investigator will also identify a back-up,research-trained blinded assessor from the awardee site. The blinded coordinator will not have access to clinic charts. The clinic coordinator will instruct participants not discuss the trial or previous weights/data collected. He or she, or the designated backup, will take the height and weight measurements at baseline and six months. In case the ISPCTN site-awardee coordinator is accidentally unblinded, the backup assessor will take over all assessments for that participant. At each measurement time point, the blinded assessor will enter data into the electronic data capture system only for that time point-the system will blind them to data from any/all other data-collection time points. The blinded site coordinator will perform the 24-hour food recalls at recruitment and six months.
• Primary Purpose: Other
• Official Title: Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
• Actual Study Start Date: Feb 3, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Actual Study Completion Date: Mar 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iAmHealthy Behavioral 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.	Behavioral: 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
Active Comparator: NewsLetter intervention This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.	Behavioral: Newsletter only arm; Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
Other: 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.	Other: Consecutive Recruitment; Recruitment of study participants through identifying potential participants through their medical records
Other: Traditional Recruitment method Flyers, advertisements, and other materials will be used to recruit potential participants to the study.	Other: Traditional Recruitment; Recruitment of potential participants through flyers and advertisements

Outcome Measures

Primary Outcome Measures

1. Participant Recruitment Rate [1 month for each recruitment option plus a 1 month catch-up period]

   Measure participant recruitment rate for both recruitment options

Secondary Outcome Measures

1. Participant Retention [6 months]

   Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.

2. Change in Child Body Mass Index From Baseline to Post-intervention [6 months]

   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

3. Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention [6 months]

   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.

4. Change in Caregiver Body Mass Index From Baseline to Post-intervention [6 months]

   The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period

5. Change in Daily Servings of Sweetened Drinks [6 months]

   This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period

6. Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention [6 months]

   This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period

7. Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention [6 months]

   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.

8. Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention [6 months]

   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

9. Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention [6 months]

   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.

Other Outcome Measures

1. Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention [6 months]

   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.

2. Staff Blinding [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Child is rural. The child lives in a rural area, as defined by the United States Department of Agriculture (USDA) Rural Urban Commuting Area (RUCA) codes (greater than or equal to 4). We will calculate this using the 2010 Zip Code, RUCA Code crosswalk.

2. Child is ages 6-11 years at the time of consent. At the time of consent, a child must be 6 to 11 years of age. A narrow age range is necessary to decrease developmental variability. Clinics may enroll a child no earlier than her or his sixth birthday (6 years, 0 months, 0 days), and may enroll a child up to her or his 12th birthday (11 years, 11 months, 30 days).

3. Child BMI percentile is ≥85th. We will use the 85th percentile as a minimal cutoff for participation, as this is the minimal criteria for the definition of overweight. There is no upper limit on BMI percentile for inclusion.

4. Child and primary caregiver speak English. For the initial feasibility pilot, we will ask that both the child and primary caregiver speak English. For the larger trial that will follow, we will accommodate Spanish-speaking participants.

5. For the iAmHealthy behavioral intervention arm, the child and primary caregiver are available when the behavioral intervention team offers the intervention for the participating clinic. The child and primary caregiver must be available for most of the iAmHealthy behavioral intervention sessions when the behavioral intervention psychologist/social worker offers the group sessions at the participants' clinic. The behavioral team will conduct these sessions via video conference and families will attend via tablets.

Exclusion Criteria:

1. Child has a physical limitation or injury that substantially limits physical mobility or has a planned medical treatment during the course of the trial that will substantially limit physical mobility. Because this trial recommends physical activity, we will exclude children who cannot comply with this health behavior.

2. Child has a known medical issue that could affect protocol compliance (e.g., cancer). If a child has a significant medical issue known to the clinic that could affect protocol compliance, we will exclude this child, as the protocol involves an intense intervention commitment.

3. Child and/or primary caregiver has a developmental delay or cognitive impairment that could affect protocol compliance. We will exclude primary caregivers and/or children with a known developmental delay, as this could negatively affect participation and measurement completion.

4. Child is enrolled in a weight-loss trial. If a child is enrolled in a weight-loss trial, we will exclude the child to avoid cross-pollination of trial interventions.

5. Child has a sibling who has already enrolled in the trial. If multiple children from the same family attempt to enroll, the statistical team will randomly select one child for enrollment. We will always allow siblings to attend the intervention, but we will not officially enroll them.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
2	University of Nebraska Medical Center	Omaha	Nebraska	United States	68114
3	Medical University of South Carolina	Charleston	South Carolina	United States	29425
4	West Virginia University	Morgantown	West Virginia	United States	26330

Sponsors and Collaborators

• IDeA States Pediatric Clinical Trials Network
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Ann Davis, PhD, University of Kansas Medical Center
• Principal Investigator: Paul Darden, MD, University of Arkansas

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 4, 2021
• Informed Consent Form - May 28, 2020

More Information

Publications

• Davis AM, Darden PM, Snowden J, Simon AE, McCulloh RJ, Bimali M, Lee J. Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics: A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network. Contemp Clin Trials. 2021 Aug;107:106476. doi: 10.1016/j.cct.2021.106476. Epub 2021 Jun 9.

• Responsible Party: IDeA States Pediatric Clinical Trials Network
• ClinicalTrials.gov Identifier: NCT04142034
• Other Study ID Numbers: 249932; U24OD024957
• First Posted: Oct 29, 2019
• Last Update Posted: Aug 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details

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

Arm/Group Title	Consecutive Recruitment Method	Traditional Recruitment Method	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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	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	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
Period Title: Recruitment Period
STARTED	535	23	0	0
COMPLETED	99	5	0	0
NOT COMPLETED	436	18	0	0
Period Title: Recruitment Period
STARTED	0	0	52	52
COMPLETED	0	0	45	50
NOT COMPLETED	0	0	7	2

Baseline Characteristics

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	52	52	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.4 (1.7)	9.2 (1.7)	9.3 (1.7)
Sex: Female, Male (Count of Participants)
Female	32 61.5%	26 50%	58 55.8%
Male	20 38.5%	26 50%	46 44.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 9.6%	3 5.8%	8 7.7%
Not Hispanic or Latino	45 86.5%	49 94.2%	94 90.4%
Unknown or Not Reported	2 3.8%	0 0%	2 1.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	16 30.8%	8 15.4%	24 23.1%
White	33 63.5%	35 67.3%	68 65.4%
More than one race	3 5.8%	8 15.4%	11 10.6%
Unknown or Not Reported	0 0%	1 1.9%	1 1%
Region of Enrollment (participants) [Number]
United States	52 100%	52 100%	104 100%
Child body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.15 (5.52)	23.04 (3.71)	24.48 (4.87)
Child body mass index adjusted for age and sex (z-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [z-score]	2.56 (1.41)	1.86 (0.55)	2.19 (1.09)
Caregiver body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	35.54 (9.93)	34.97 (8.48)	35.24 (9.12)
Daily sweetened drink servings (daily sweetened drink servings) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [daily sweetened drink servings]	1.16 (1.30)	1.18 (1.20)	1.17 (1.24)
Daily fruit and vegetable servings (daily fruit and vegetable servings) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [daily fruit and vegetable servings]	2.42 (1.21)	2.62 (1.43)	2.53 (1.33)
Daily servings of red foods (daily servings of red foods) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [daily servings of red foods]	6.30 (1.83)	6.39 (2.11)	6.35 (1.97)
Average daily minutes of moderate to vigorous physical activity (Avg daily minutes of MVPA) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Avg daily minutes of MVPA]	38.92 (36.92)	55.46 (62.70)	47.76 (52.54)
MVPA (%) (% time spent in MVPA) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% time spent in MVPA]	5.15 (2.58)	6.13 (3.45)	5.70 (3.11)

Outcome Measures

1. Primary Outcome

Title	Participant Recruitment Rate
Description	Measure participant recruitment rate for both recruitment options
Time Frame	1 month for each recruitment option plus a 1 month catch-up period

Outcome Measure Data

Analysis Population Description

Potential study participants who were approached about the study using one of the two recruitment methods

Arm/Group Title	Consecutive Recruitment Method	Traditional Recruitment Method
Arm/Group Description	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	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
Measure Participants	535	23
Count of Participants [Participants]	99 190.4%	5 9.6%

2. Secondary Outcome

Title	Participant Retention
Description	Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study participants who were randomized to one of the two behavioral interventions

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	52	52
Count of Participants [Participants]	45 86.5%	50 96.2%

3. Secondary Outcome

Title	Change in Child Body Mass Index From Baseline to Post-intervention
Description	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
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	34	39
Mean (Standard Deviation) [kg/m^2]	0.32 (2.42)	1.25 (2.22)

4. Secondary Outcome

Title	Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	34	39
Mean (Standard Deviation) [z-score]	-0.11 (0.53)	0.12 (0.48)

5. Secondary Outcome

Title	Change in Caregiver Body Mass Index From Baseline to Post-intervention
Description	The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	34	39
Mean (Standard Deviation) [kg/m^2]	-0.32 (3.19)	-0.90 (3.60)

6. Secondary Outcome

Title	Change in Daily Servings of Sweetened Drinks
Description	This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants for whom data on the daily servings of sweetened drinks consumed was available at baseline and at the end of the intervention period

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	43	50
Mean (Standard Deviation) [daily servings of sweetened drinks]	0.80 (0.72)	0.81 (0.65)

7. Secondary Outcome

Title	Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention
Description	This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	43	50
Mean (Standard Deviation) [Daily fruit/vegetable servings]	0.36 (1.91)	0 (1.78)

8. Secondary Outcome

Title	Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants for whom information on the number of daily servings of red food were available at baseline and post-intervention

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	43	50
Mean (Standard Deviation) [daily red food servings]	-0.78 (1.95)	-0.45 (2.56)

9. Secondary Outcome

Title	Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention
Description	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
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	27	31
Mean (Standard Deviation) [change in daily minutes of MVPA]	-14.64 (39.88)	-28.74 (65.61)

10. Secondary Outcome

Title	Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	21	27
Mean (Standard Deviation) [change in % time spent in MVPA]	-0.79 (2.71)	-1.60 (2.13)

11. Other Pre-specified Outcome

Title	Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The analysis population is the study participants randomized to the iAmHealthy + Newsletter behavioral intervention who were retained through the 6-month intervention period

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention
Arm/Group Description	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
Measure Participants	45
Count of Participants [Participants]	29 55.8%

12. Other Pre-specified Outcome

Title	Staff Blinding
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants who were randomized to one of the two behavioral interventions

Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention	NewsLetter Intervention
Arm/Group Description	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	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
Measure Participants	52	52
Mean (Standard Deviation) [index]	0.12 (0.13)	0.02 (0.13)

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	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.
Arm/Group Title	iAmHealthy + Newsletter Behavorial Intervention		NewsLetter Intervention
Arm/Group Description	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		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
All Cause Mortality
	iAmHealthy + Newsletter Behavorial Intervention		NewsLetter Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Serious Adverse Events
	iAmHealthy + Newsletter Behavorial Intervention		NewsLetter Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	iAmHealthy + Newsletter Behavorial Intervention		NewsLetter Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/52 (1.9%)		0/52 (0%)
Musculoskeletal and connective tissue disorders
Upper limb	1/52 (1.9%)	1	1/52 (1.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.