Autism Spectrum DisorderFRESH-ANCT05741840
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
A study testing PBT-A and Health Education (HE) in people with Autism Spectrum Disorder and Obesity, Childhood, run by University of California, San Diego at 1 site in United States.
Trial summary
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Obesity, Childhood, Autism
- What is being tested?
- PBT-A and Health Education (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A child with OW/OB (>=85% BMI for age) aged 6-12 years
- Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
- The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
- The parent who is responsible for food preparation is willing to participate
- The family is willing to commit to attending all treatment and assessment sessions
- Child on a stable regimen of prescription medications which affect appetite or weight (minimum of 3 months)
Show all 9Show fewer
- Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity.
- Child and/or parent are not participating in another organized weight control program
- Family owns a device that can facilitate zoom meetings
Who cannot join
- Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
- Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
- Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
- Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
- Child is taking medication for the purpose of weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
About this study
Official title: Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
Read the detailed description
The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.
- Conditions
- Autism Spectrum Disorder, Obesity, Childhood, Autism
- Being tested
- PBT-A, Health Education (HE)
- Keywords
- obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children
- Medical subject headings
- Autism Spectrum Disorder, Pediatric Obesity, Autistic Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBT-ABehavioural
Also called parent based treatment, family based behavioral treatment
PBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Health Education (HE)Behavioural
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
| Study group | Role | What they receive |
|---|---|---|
| PBT-A | Experimental | PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth. Receives: Behavioral: PBT-A |
| Health Education | Active comparator | This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth. Receives: Behavioral: Health Education (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMIz age and sex adjusted BMI (kg/m^2)
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
Measured: Change from baseline to month 3, 6, 12, and 18
Child %BMIp95
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights
Measured: Change from baseline to month 3, 6, 12, and 18
Secondary outcomes (8)
Parent Dietary Intake
Block Fat/Sugar/Fruit/Vegetable Screener for adults
Measured: Change from baseline to month 6, 12, and 18
Child Dietary Intake
BLOCK kids food screener completed by parent
Measured: Change from baseline to month 6, 12, and 18
Parent Physical Activity
The International Physical Activity Questionnaire (IPAQ)
Measured: Change from baseline to month 6, 12, and 18
Child Physical Activity
The Children's Physical Activity Questionnaire (C-PAQ) parent proxy
Measured: Change from baseline to month 6, 12, and 18
Child Mealtime Behaviors
The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors
Measured: Change from baseline to month 6, 12, and 18
Parent self-efficacy
The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence.
Measured: Change from baseline to month 6, 12, and 18
Parent body mass index (BMI)
kg/m^2
Measured: Change from baseline to mid-treatment, months: 3, 6, 12, and 18
Parenting as measured by the Alabama Parenting Questionnaire (APQ)
Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5.
Measured: Change from baseline to month 6, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start18 Aug 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741840
- Sponsor's protocol ID
- 802230
- Other IDs
- R01HD106991
- Acronym
- FRESH-A
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutelle KN, Eichen DM, Martinez K, Pinson CK, Strong DR, Reed KL, Akshoomoff N, Rhee KE, Brookman-Frazee L. Design of the FRESH-A study: A randomized controlled trial evaluating telehealth parent-only treatment for autistic youth with overweight/obesity. Contemp Clin Trials. 2026 Jul;166:108330. doi: 10.1016/j.cct.2026.108330. Epub 2026 Apr 28.
PubMed 42061554
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
- ClinicalTrials.gov ID
- NCT05741840
- Acronym / sponsor ID
- FRESH-A / 802230
- Conditions
- Autism Spectrum Disorder, Obesity, Childhood, Autism
- Keywords
- obesity, treatment, intervention, Autism, behavioral treatment, parent based treatment, children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
Detailed description
The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBT-A | Experimental | Behavioral: PBT-APBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth. |
| Health Education | Active comparator | Behavioral: Health Education (HE)This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- A child with OW/OB (>=85% BMI for age) aged 6-12 years
- Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
- The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician
- The parent who is responsible for food preparation is willing to participate
- The family is willing to commit to attending all treatment and assessment sessions
Key exclusion criteria (6 listed)
- Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
- Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
- Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
- Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration
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 |
|---|---|---|
| PBT-AAlso: parent based treatment, family based behavioral treatmentPBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills. | Behavioural | PBT-A |
| Health Education (HE)The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. | Behavioural | Health Education |
Primary outcome
Child BMIz age and sex adjusted BMI (kg/m^2)
Time frame: Change from baseline to month 3, 6, 12, and 18
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
Child %BMIp95
Time frame: Change from baseline to month 3, 6, 12, and 18
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights
8 secondary outcomes
Parent Dietary Intake
Time frame: Change from baseline to month 6, 12, and 18
Child Dietary Intake
Time frame: Change from baseline to month 6, 12, and 18
Parent Physical Activity
Time frame: Change from baseline to month 6, 12, and 18
Child Physical Activity
Time frame: Change from baseline to month 6, 12, and 18
Child Mealtime Behaviors
Time frame: Change from baseline to month 6, 12, and 18
Parent self-efficacy
Time frame: Change from baseline to month 6, 12, and 18
Parent body mass index (BMI)
Time frame: Change from baseline to mid-treatment, months: 3, 6, 12, and 18
Parenting as measured by the Alabama Parenting Questionnaire (APQ)
Time frame: Change from baseline to month 6, 12, and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42061554Boutelle KN, Eichen DM, Martinez K, Pinson CK, Strong DR, Reed KL, Akshoomoff N, Rhee KE, Brookman-Frazee L. Design of the FRESH-A study: A randomized controlled trial evaluating telehealth parent-only treatment for autistic youth with overweight/obesity. Contemp Clin Trials. 2026 Jul;166:108330. doi: 10.1016/j.cct.2026.108330. Epub 2026 Apr 28.
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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.
Kerri Boutelle, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBT-A and Health Education (HE) in people with Autism Spectrum Disorder and Obesity, Childhood, run by University of California, San Diego at 1 site 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 9 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Child BMIz age and sex adjusted BMI (kg/m^2) (time frame: Change from baseline to month 3, 6, 12, and 18). The study lists 2 primary outcomes in all. 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 NCT05741840, which also lists 1 linked publication.
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 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.