AutismNCT02328638
Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
A study testing Parent Education Program and Manual-based Behavioral Treatment in people with Autism and Obesity, run by Emory University at 1 site in United States.
Trial summary
The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- What is being tested?
- Parent Education Program and Manual-based Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
- Overweight status, as evidenced by a BMI percentile > 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods
Who cannot join
- Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
- Children with unstable medical conditions will be excluded for safety concerns
- Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Feeding Disorders Program at the Marcus Autism Center
Atlanta, Georgia, 30329
About this study
The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.
Read the detailed description
The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.
- Being tested
- Parent Education Program, Manual-based Behavioral Treatment
- Keywords
- ASD
- Medical subject headings
- Autistic Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Education ProgramBehavioural
Also called PEP
The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.
Manual-based Behavioral TreatmentBehavioural
The Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals.
| Study group | Role | What they receive |
|---|---|---|
| Manual-based Behavioral Treatment | Active comparator | up to 16 weekly behavioral therapy sessions (intervention) following the CHANGE obesity manual, lasting approximately 45 minutes and nutritional therapy sessions, lasting approximately 30 to 60 minutes. Receives: Behavioral: Manual-based Behavioral Treatment |
| Parent Education Program | Placebo comparator | up to 16 weekly behavioral therapy sessions following the parent education program Receives: Behavioral: Parent Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index percentile/ratio
Body Mass Index (BMI) is a number calculated from a person's weight divided by height.
Measured: baseline, post treatment (up to 16 weeks)
Secondary outcomes (2)
Change in intake of healthy food
The Nutrition arm of the intervention is based on our dietitian's unique ASD-specific adaptations to Best Practices in dietetics and will be supplemented by Children's Healthcare of Atlanta's Strong4Life program.
Measured: baseline, post treatment (up to 16 weeks)
Change in physical activity
The F.I.T.T. Principle will be applied to the physical activity recommendations by identifying the frequency, intensity, time, and type of exercise.
Measured: baseline, post treatment (up to 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen K. Criado, Emory University
- Investigators
- Kristen K Criado, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328638
- Sponsor's protocol ID
- IRB00073170
- Status last verified
- Jan 2016
- First submitted
- 23 Dec 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
- ClinicalTrials.gov ID
- NCT02328638
- Acronym / sponsor ID
- IRB00073170
- Keywords
- ASD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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 purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.
Detailed description
The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual-based Behavioral Treatment | Active comparator | Behavioral: Manual-based Behavioral Treatmentup to 16 weekly behavioral therapy sessions (intervention) following the CHANGE obesity manual, lasting approximately 45 minutes and nutritional therapy sessions, lasting approximately 30 to 60 minutes. |
| Parent Education Program | Placebo comparator | Behavioral: Parent Education Programup to 16 weekly behavioral therapy sessions following the parent education program |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
- Overweight status, as evidenced by a BMI percentile > 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods
Key exclusion criteria (3 listed)
- Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
- Children with unstable medical conditions will be excluded for safety concerns
- Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed
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 |
|---|---|---|
| Parent Education ProgramAlso: PEPThe PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders. | Behavioural | Parent Education Program |
| Manual-based Behavioral TreatmentThe Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals. | Behavioural | Manual-based Behavioral Treatment |
Primary outcome
Change in body mass index percentile/ratio
Time frame: baseline, post treatment (up to 16 weeks)
Body Mass Index (BMI) is a number calculated from a person's weight divided by height.
2 secondary outcomes
Change in intake of healthy food
Time frame: baseline, post treatment (up to 16 weeks)
Change in physical activity
Time frame: baseline, post treatment (up to 16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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.
Kristen K Criado, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Education Program and Manual-based Behavioral Treatment in people with Autism and Obesity, run by Emory University 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 2 inclusion and 3 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 20 Jan 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in body mass index percentile/ratio (time frame: baseline, post treatment (up to 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.