N/A
N=558
Feasibility Trial of the iAMHealthy Intervention
Obesity; Rurality
Bottom Line
View on ClinicalTrials.gov: NCT04142034 ↗Enrolled (actual)
558
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Participant Recruitment Rate — 99; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- the iAmHealthy Behavioral Intervention (Behavioral); Newsletter only arm (Behavioral); Consecutive Recruitment (Other); Traditional Recruitment (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- IDeA States Pediatric Clinical Trials Network
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Recruitment Rate |
99; 5 | — |
| SECONDARY Participant Retention |
45; 50 | — |
| SECONDARY Change in Child Body Mass Index From Baseline to Post-intervention |
0.32; 1.25 | — |
| SECONDARY Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention |
-0.11; 0.12 | — |
| SECONDARY Change in Caregiver Body Mass Index From Baseline to Post-intervention |
-0.32; -0.90 | — |
| SECONDARY Change in Daily Servings of Sweetened Drinks |
0.80; 0.81 | — |
| SECONDARY Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention |
0.36; 0 | — |
| SECONDARY Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention |
-0.78; -0.45 | — |
| SECONDARY Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention |
-14.64; -28.74 | — |
| SECONDARY Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention |
-0.79; -1.60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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).
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04142034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.