Obesity; RuralityiAmHealthyNCT04142034
Feasibility Trial of the iAMHealthy Intervention
A study testing the iAmHealthy Behavioral Intervention, Newsletter only arm and Consecutive Recruitment in people with Obesity; Rurality, run by IDeA States Pediatric Clinical Trials Network at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity; Rurality
- What is being tested?
- the iAmHealthy Behavioral Intervention, Newsletter only arm and Consecutive Recruitment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Feb 2020to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- -
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
West Virginia University
Morgantown, West Virginia, 26330
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
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.)
Read more
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.
Read the 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.
- Conditions
- Obesity; Rurality
- Being tested
- the iAmHealthy Behavioral Intervention, Newsletter only arm, Consecutive Recruitment, Traditional Recruitment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the iAmHealthy Behavioral InterventionBehavioural
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 armBehavioural
Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise
Consecutive RecruitmentOther
Recruitment of study participants through identifying potential participants through their medical records
Traditional RecruitmentOther
Recruitment of potential participants through flyers and advertisements
| Study group | Role | What they receive |
|---|---|---|
| iAmHealthy Behavioral Intervention | Experimental | 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. Receives: Behavioral: the iAmHealthy Behavioral Intervention |
| NewsLetter intervention | Active comparator | This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months. Receives: Behavioral: Newsletter only arm |
| Consecutive Recruitment method | Other | 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. Receives: Other: Consecutive Recruitment |
| Traditional Recruitment method | Other | Flyers, advertisements, and other materials will be used to recruit potential participants to the study. Receives: Other: Traditional Recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
Measure participant recruitment rate for both recruitment options
Measured: 1 month for each recruitment option plus a 1 month catch-up period
Secondary outcomes (9)
Participant Retention
Calculate participant retention as the percent of randomized participants who remain in the study through the final measurement point.
Measured: 6 months
Change in Child Body Mass Index From Baseline to Post-intervention
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
Measured: 6 months
Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
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.
Measured: 6 months
Change in Caregiver Body Mass Index From Baseline to Post-intervention
The baseline caregiver body mass index (BMI) is subtracted from the caregiver BMI taken at the end of the intervention period
Measured: 6 months
Change in Daily Servings of Sweetened Drinks
This measure is difference in the daily servings of sweetened drinks consumed from baseline to the end of the intervention period
Measured: 6 months
Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention
This measure is the change in the number of servings of fruits and vegetables consumed daily from baseline to after the intervention period
Measured: 6 months
Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention
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.
Measured: 6 months
Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention
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
Measured: 6 months
Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start3 Feb 2020
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity; RuralityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDeA States Pediatric Clinical Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ann Davis, PhD, Principal investigator, University of Kansas Medical CenterPaul Darden, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142034
- Sponsor's protocol ID
- 249932
- Other IDs
- U24OD024957
- Acronym
- iAmHealthy
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2019
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34118426Lancaster 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.
PubMed 41746798Zhang 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.
PubMed 38172325Nguyen 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.
PubMed 37036783Darden 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.
PubMed 36445709
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics
- ClinicalTrials.gov ID
- NCT04142034
- Acronym / sponsor ID
- iAmHealthy / 249932
- Conditions
- Obesity; Rurality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- IDeA States Pediatric Clinical Trials NetworkResearch network
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 22 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| iAmHealthy Behavioral Intervention | Experimental | Behavioral: the iAmHealthy Behavioral InterventionThis 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. |
| NewsLetter intervention | Active comparator | Behavioral: Newsletter only armThis intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months. |
| Consecutive Recruitment method | Other | Other: Consecutive RecruitmentUsing 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. |
| Traditional Recruitment method | Other | Other: Traditional RecruitmentFlyers, advertisements, and other materials will be used to recruit potential participants to the study. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the iAmHealthy Behavioral InterventioniAmHealthy 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 | Behavioural | iAmHealthy Behavioral Intervention |
| Newsletter only armNewsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise | Behavioural | NewsLetter intervention |
| Consecutive RecruitmentRecruitment of study participants through identifying potential participants through their medical records | Other | Consecutive Recruitment method |
| Traditional RecruitmentRecruitment of potential participants through flyers and advertisements | Other | Traditional Recruitment method |
Primary outcome
Participant Recruitment Rate
Time frame: 1 month for each recruitment option plus a 1 month catch-up period
Measure participant recruitment rate for both recruitment options
9 secondary outcomes
Participant Retention
Time frame: 6 months
Change in Child Body Mass Index From Baseline to Post-intervention
Time frame: 6 months
Change in Child BMI Adjusted for Age and Sex From Baseline to Post-intervention
Time frame: 6 months
Change in Caregiver Body Mass Index From Baseline to Post-intervention
Time frame: 6 months
Change in Daily Servings of Sweetened Drinks
Time frame: 6 months
Change in Number of Servings of Fruits and Vegetables Consumed Daily From Baseline to Post-intervention
Time frame: 6 months
Change in Number of Red Food Servings Consumed Daily From Baseline to Post-intervention
Time frame: 6 months
Change in the Daily Minutes Spent in Moderate to Vigorous Physical Activity (MVPA) From Baseline to Post-intervention
Time frame: 6 months
Change in the % of Time Spent in Moderate to Vigorous Physical Activity (MVPA ) While Wearing Activity Monitor From Baseline to Post-intervention
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34118426Davis 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.
- Derived from this study: PubMed 41746798Lancaster 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.
- Derived from this study: PubMed 38172325Zhang 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.
- Derived from this study: PubMed 37036783Nguyen 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.
- Derived from this study: PubMed 36445709Darden 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Davis, PhD principal investigator
University of Kansas Medical Center
Paul Darden, MD principal investigator
University of Arkansas
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the iAmHealthy Behavioral Intervention, Newsletter only arm and Consecutive Recruitment in people with Obesity; Rurality, run by IDeA States Pediatric Clinical Trials Network at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: 1 month for each recruitment option plus a 1 month catch-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142034, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.