← Back to Search

Behavioral Intervention

Telehealth Program for Autism (FRESH-A Trial)

N/A

Recruiting

Led By Kerri Boutelle, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month 3, 6, 12, and 18

Awards & highlights

FRESH-A Trial Summary

This trial will study if a telehealth program can help children with autism & obesity/overweight better than health education.

Who is the study for?

This trial is for families with a child aged 6-12 who has autism and is overweight, with no medical conditions limiting physical activity. The family must have technology for telehealth sessions, the parent responsible for meals must participate, and they should commit to all sessions without being in another weight control program.Check my eligibility

What is being tested?

The study tests a telehealth-based behavioral program (PBT-A) against health education (HE) to help children with autism manage their weight. It aims to see if PBT-A can be effective when delivered through remote means like video calls.See study design

What are the potential side effects?

Since this trial involves behavior modification and education programs rather than medication, traditional side effects are not expected. However, participants may experience stress or frustration related to lifestyle changes.

FRESH-A Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month 3, 6, 12, and 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month 3, 6, 12, and 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 3, 6, 12, and 18 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Child %BMIp95

Child BMIz age and sex adjusted BMI (kg/m^2)

Secondary outcome measures

Child Dietary Intake

Child Mealtime Behaviors

Child Mealtime Behaviors at home

+6 more

FRESH-A Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PBT-AExperimental Treatment1 Intervention

PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.

Group II: Health EducationActive Control1 Intervention

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,580 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,521,275 Total Patients Enrolled

Kerri Boutelle, PhDPrincipal InvestigatorUniversity of California, San Diego

5 Previous Clinical Trials

639 Total Patients Enrolled

Media Library

PBT-A (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05741840 — N/A

Childhood Obesity Research Study Groups: Health Education, PBT-A

Childhood Obesity Clinical Trial 2023: PBT-A Highlights & Side Effects. Trial Name: NCT05741840 — N/A

PBT-A (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741840 — N/A

Frequently Asked Questions

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

Is the study cohort open to senior citizens above a certain age?

"This medical study is enrolling children aged between 6 and 12 years old."

Answered by AI

Is enrollment open for this medical research study?

"This clinical trial is enrolling a cohort of 150 individuals aged between 6 and 12 who have been diagnosed with autism."

Answered by AI

Is enrollment open for this clinical trial presently?

"It appears that the clinical trial in question is no longer recruiting patients. The posting was initially made on June 1st, 2023 and the page was last edited on February 23rd of the same year. However, many other studies are still enrolling participants at this time with a total of 1297 trials currently underway."

Answered by AI

What beneficial insights are expected from this research?

"The primary metric of this trial, assessed at month 3, 6, 12 and 18 post-baseline will be the Child BMIz age and sex adjusted BMI (kg/m^2). Other measurements monitored throughout the study include Child Dietary Intake as recorded by a BLOCK kids food screener completed by a parent or guardian, Parent Physical Activity determined through an International Physical Activity Questionnaire (IPAQ), and lastly Child Physical Activity measured with The Children's Physical Activity Questionnaire (C-PAQ) using data provided from parental proxies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

Kerri Boutelle 2023. "Family, Responsibility, Education, Support, and Health for Families With a Child With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741840.

All > Autism San Diego