Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2020-02-03
2021-03-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
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.
Study Groups
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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.
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
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
Interventions
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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 only arm
Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
Consecutive Recruitment
Recruitment of study participants through identifying potential participants through their medical records
Traditional Recruitment
Recruitment of potential participants through flyers and advertisements
Eligibility Criteria
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Inclusion Criteria
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.
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Exclusion Criteria
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.
6 Years
11 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
IDeA States Pediatric Clinical Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Ann Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Paul Darden, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Medical University of South Carolina
Charleston, South Carolina, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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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.
Zhang E, Davis AM, Jimenez EY, Lancaster B, Serrano-Gonzalez M, Chang D, Lee J, Lai JS, Pyles L, VanWagoner T, Darden P. Validation of remote anthropometric measurements in a rural randomized pediatric clinical trial in primary care settings. Sci Rep. 2024 Jan 3;14(1):411. doi: 10.1038/s41598-023-50790-1.
Nguyen L, Phan TL, Falini L, Chang D, Cottrell L, Dawley E, Hockett CW, VanWagoner T, Darden PM, Davis AM. Rural Family Satisfaction With Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics. Child Obes. 2024 Apr;20(3):147-154. doi: 10.1089/chi.2022.0210. Epub 2023 Apr 10.
Darden PM 2nd, Davis AM, Lee JY, Bimali M, Simon AE, Atz AM, Lim CS, Phan TT, Roberts JR, McCulloh RJ, Pyles L, Shaffer M, Snowden JN. Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2244040. doi: 10.1001/jamanetworkopen.2022.44040.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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249932
Identifier Type: -
Identifier Source: org_study_id
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