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iAmHealthy
Sponsor study identifier
Secondary identifiers
NIH
interventional
104
1 country
4
Study Start
February 3, 2020
Actual (reported)Primary Completion
March 25, 2021
Actual (reported)Study Completion
March 25, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2019
Actual (reported)October 29, 2019
Actual (reported)February 3, 2020
Actual (reported)March 25, 2021
Actual (reported)March 25, 2021
Actual (reported)August 22, 2022
Actual (reported)Participant Recruitment Rate
Measure participant recruitment rate for both recruitment options
1 month for each recruitment option plus a 1 month catch-up period
Participant Retention
6 months
Change in Child Body Mass Index From Baseline to Post-intervention
6 months
Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
6 months
Change in Caregiver Body Mass Index From Baseline to Post-intervention
6 months
Change in Daily Servings of Sweetened Drinks
6 months
Participants in the iAmHealthy+ Newsletter Behavioral Intervention Who Receive at Least 80% of the Planned Intervention
6 months
Staff Blinding
6 months
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.
This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months.
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
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
West Virginia University
Morgantown, West Virginia, 26330, United States
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.
Lancaster BD, Chang D, Lee J, Snowden J, Lawrence L, Eldredge Hubberd D, Phan TT, Hsia DS, Hockett CW, Pyles L, Kong AS, Roberts J, McCulloh R, Darden PM, Davis AM. Retention, blinding, and health outcomes from a rural pediatric obesity feasibility randomized control trial. J Pediatr Psychol. 2026 Jun 1;51(6):472-482. doi: 10.1093/jpepsy/jsag016.
Ann Davis, PhD
University of Kansas Medical Center
Paul Darden, MD
University of Arkansas
104 participants (actual enrollment reported by the registry).
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.
Flyers, advertisements, and other materials will be used to recruit potential participants to the study.
Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
Recruitment of study participants through identifying potential participants through their medical records
Recruitment of potential participants through flyers and advertisements
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
First Submitted
October 25, 2019
First Posted
October 29, 2019
Study Start
February 3, 2020
Actual (reported)Primary Completion
March 25, 2021
Actual (reported)Study Completion
March 25, 2021
Actual (reported)Last Updated
September 13, 2022
Results First Posted
August 22, 2022
Record last verified: 2022-08
We will conduct this trial in accordance with the following publication and data sharing policies and regulations: * NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. * ISPCTN Publications and Presentations Policy, which ensures accurate, responsible, and efficient communication of findings from ISPCTN clinical trials. The ISPCTN Steering Committee has approved and ratified the ISPCTN Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from the NIH and the DCOC. * NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. Other researchers my request data from this trial by contacting Jeannette Lee, PhD, at the DCOC.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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