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Intervention Group for Childhood Obesity

N/A

Recruiting

Led By Katherine A Sauder, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

7-to-10-years-old

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 7

Awards & highlights

Study Summary

This trial aims to test a program that helps children in rural areas to have a healthy diet and be more active in order to reduce their risk of developing Type 2 Diabetes. Participants in the intervention group

Who is the study for?

This trial is for children aged 7 to 10 living in Bennett, Colorado. They must speak English or Spanish and have a parent or caregiver willing to participate. It's designed for those at risk of childhood obesity and Type 2 Diabetes.Check my eligibility

What is being tested?

The study tests a lifestyle program called the Bennett Kids PowerUP Project aimed at promoting healthy eating and activity among rural kids. Participants will get health coach sessions, activity packs, and resources over six months.See study design

What are the potential side effects?

Since this is a lifestyle modification program focusing on diet and physical activities rather than medication, no direct medical side effects are expected. However, changes in routine may cause temporary stress or resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 and 10 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Dietary Intake (MyPyramid Equivalents) at 7 months

Change in Fruit and Vegetable Intake (carotenoid concentration) at 7 months

Change in Sugar-Sweetened Beverage Intake (carbon isotope ratio) at 7 months

Secondary outcome measures

Change in Physical Activity at 7 months

Change in Screen Time at 7 months

Other outcome measures

Acceptability and Engagement Barriers

Change in Body Mass Index (BMI) values at 7 months

Change in Glucose levels at 7 months

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through: 16 self-contained, parent-guided activity kits, 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, unlimited access to a resource toolbox.

Group II: Control GroupActive Control1 Intervention

Control group programming consists of: 6 parent-guided activity kits focused on STEM activities, 6 monthly check-in calls to support retention. The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

American Diabetes AssociationOTHER

139 Previous Clinical Trials

99,546 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,670 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,466 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals interested in participating in this research project?

"This clinical investigation aims to enroll 60 individuals, aged between 7 and 10 years old, who are coping with childhood obesity. Candidates must reside in the vicinity of Bennett, Colorado and be fluent in either English or Spanish. Additionally, it is required that they have at least one parent or primary caregiver willing to actively engage in the study."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Clinicaltrials.gov shows that this study is not actively seeking participants at the moment. The trial was initially posted on February 1st, 2024 and last updated on January 25th, 2024. However, it's worth noting that there are currently 190 other studies available for patient enrollment."

Answered by AI

Are participants aged 85 and above eligible to be enrolled in this study?

"To be eligible for this clinical trial, applicants must fall between the ages of 7 and 10. Among all the available studies, there are a total of 148 trials specifically targeting patients under the age of 18, while 52 studies focus on individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Bennett Kids PowerUP Project

2024. "The Bennett Kids PowerUP Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05858580.