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Feasibility Trial of the iAMHealthy Intervention (iAmHealthy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142034
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
IDeA States Pediatric Clinical Trials Network

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.

Children and caregivers will have their height and weight measured. The study team will use these measurements to see if the child has a high BMI (Body Mass Index). Only children who have an unhealthy weight (high BMI) will be part of the study. The guardian will need to report what the child eats for about 6 days. The child will need to wear an activity monitor for about 1 week on 2 different occasions. Participants will be asked to answer survey questions and provide information (race, ethnic group, and similar information) about their families.

Information from this study will be used to help design future, larger, research studies.


Condition or disease Intervention/treatment Phase
Obesity; Rurality Behavioral: the iAmHealthy Behavioral Intervention Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This feasibility trial is a multisite, RCT of two different methods of identifying and recruiting participants into 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 : February 3, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: iAmHealthy 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.
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: 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




Primary Outcome Measures :
  1. Participant Recruitment Rate [ Time Frame: 1 month for each recruitment option ]
    Measure participant recruitment rate for both recruitment options


Secondary Outcome Measures :
  1. Participant Retention [ Time Frame: 6 months ]
    Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.


Other Outcome Measures:
  1. Dose [ Time Frame: 6 months ]
    Among participants randomized to the iAmHealthy behavioral intervention arm who are retained through the final measurement, we will calculate the proportion of the participants who receive at least 80% of the planned intervention (dose).

  2. Staff Blinding [ Time Frame: 6 months ]
    to estimate the percentage of correct guessing beyond the level expected by chance in each treatment arm. Specifically, the ISPCTN site-awardee coordinator/investigator and a designated backup will remain blinded and serve as the blinded assessor.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142034


Contacts
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Contact: Jeanette Lee, PHD 501-320-7344 JYLee@uams.edu
Contact: Jessica Snowden, MD 501-526-5837 JSnowden@uams.edu

Locations
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United States, Delaware
Nemours/Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Thao-Ly Phan, MD, MPH       thaoly.phan@nemours.org   
Contact: Danika Perry, PsyD       danika.perry@nemours.org   
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Russell McCulloh, MD       rmcculloh@childrensomaha.org   
Contact: Luke Murphy, MS       luke.murphy@unmc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: James Roberts, MD       robertsj@musc.edu   
Contact: Andrew Atz, MD       atzam@musc.edu   
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26330
Contact: Lee Pyles, MD       lpyles@hsc.wvu.edu   
Contact: Taylor Hershberger       thershb2@hsc.wvu.edu   
Sponsors and Collaborators
IDeA States Pediatric Clinical Trials Network
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Responsible Party: IDeA States Pediatric Clinical Trials Network
ClinicalTrials.gov Identifier: NCT04142034    
Other Study ID Numbers: 249932
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Per data and sharing polices of NIH and the ISPCTN.
Access Criteria: TBA

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No