Family, Responsibility, Education, Support, and Health for Families With a Child With Autism (FRESH-A)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Obesity, Childhood; Autism
• Intervention / Treatment: Behavioral: Health Education (HE); Behavioral: PBT-A

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. A child with OW/OB (>=85% BMI for age) aged 6-12 years
2. Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
3. 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
4. The parent who is responsible for food preparation is willing to participate
5. The family is willing to commit to attending all treatment and assessment sessions
6. Child on a stable regimen of prescription medications which affect appetite or weight (minimum of 3 months)
7. 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.
8. Child and/or parent are not participating in another organized weight control program
9. Family owns a device that can facilitate zoom meetings

Exclusion Criteria:

1. 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
2. Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
3. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
4. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
5. 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
6. Child is taking medication for the purpose of weight loss

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBT-A; PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.	Behavioral: PBT-A; 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.; Other Names: parent based treatment; family based behavioral treatment
Active Comparator: Health Education; This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.	Behavioral: Health Education (HE); The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Change from baseline to month 3, 6, 12, and 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Physical Activity	The International Physical Activity Questionnaire (IPAQ)	Change from baseline to month 6, 12, and 18
Parent body mass index (BMI)	kg/m^2	Change from baseline to mid-treatment, months: 3, 6, 12, and 18
Parent Dietary Intake	Block Fat/Sugar/Fruit/Vegetable Screener for adults	Change from baseline to month 6, 12, and 18
Child Dietary Intake	BLOCK kids food screener completed by parent	Change from baseline to month 6, 12, and 18
Child Physical Activity	The Children's Physical Activity Questionnaire (C-PAQ) parent proxy	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	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.	Change from baseline to month 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.	Change from baseline to month 6, 12, and 18

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Kerri Boutelle, PhD, University of California, San Diego

Publications and helpful links

General Publications

• Boutelle KN, Eichen DM, Martinez K, Pinson CK, Strong DM, 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 Apr 28:108330. doi: 10.1016/j.cct.2026.108330. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: treatment; obesity; children; Autism; intervention; behavioral treatment; parent based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Autism Spectrum Disorder; Obesity; Autistic Disorder; Pediatric Obesity
• Other Study ID Numbers: 802230; R01HD106991 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No