Autism Spectrum DisorderNCT03047018
Open Trial Obesity CHANGE Program ASD
A study testing The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program in people with Autism Spectrum Disorder and Obesity, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Obesity
- What is being tested?
- The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 20 Mar 2020
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with ASD using DSM-5 criteria, and clinically significant SCQ score.
- Children with mild to moderate food selectivity, as reflected by a) a diet involving at least 6 food items, b) accepting at least one fruit or vegetable as measured by the Food Preference Inventory (FPI), and c) engaging in low mealtime behavior problems on Brief Autism Mealtime Behavior Inventory (BAMBI) Food Refusal subscale
- Child with a clinic-confirmed body mass index (BMI) percentile in the obese range (i.e., > 95th percentile)
- Parent (primary caregiver) who agrees to participate and attend treatment sessions
- Participating parent able to speak, understand, read, and write in English (assessments, curriculum materials and instructions are in English)
Who cannot join
- Children with severe feeding problems (e.g., < 5 preferred foods as measured by the FPI) or complex medical issues (e.g., gastrostomy-tube or formula dependent) who require a different treatment approach
- Children on medication associated with weight gain in ASD (e.g., risperidone) that has not yet stabilized (stability criteria defined as 6 months or longer i.e. child has been on medication for less than 6 months).
- Children with serious behavioral problems (i.e., aggression, tantrums, self-injury) or another psychiatric condition that requires a different treatment approach.
- Children with unstable medical conditions or those with a known associated with weight problems will not be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
Twenty children with autism spectrum disorder (ASD) who are also overweight will participate in this study at the Marcus Autism Center. All children who enroll will receive the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. This involves 16 sessions over six months. After the six months, participants will come back every month for three months for a follow up visit. Therefore the study will last a total of nine months.
Read the detailed description
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
This is a 24-week, open trial pilot of 20 children (ages 5 to 12 years old) with ASD and obesity. Subjects will be enrolled in the CHANGE program, a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. After 24 weeks, subjects will be asked to return for follow up assessments at 1, 2 and 3 months later.
The primary aims of this project are to 1) determine the feasibility of the intervention, 2) examine preliminary efficacy, and 3) obtain feedback from parents to improve the effectiveness of the intervention and fit for families.
- Conditions
- Autism Spectrum Disorder, Obesity
- Being tested
- The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program
- Keywords
- Nutrition
- Medical subject headings
- Autism Spectrum Disorder, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) ProgramBehavioural
The CHANGE program is a a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. Nutrition intervention focuses on decreasing excess calories from liquids and solids and creating a balanced meal plan. Physical activity intervention uses fading strategies to increase participation in exercise. Behavior strategies promote success with meeting goals. Problem-solving techniques address challenges to adherence with implementing the program in the home setting. The standardized protocols include educational handouts, clinic-based activities and assessment procedures, and caregiver-directed homework and data collection.
| Study group | Role | What they receive |
|---|---|---|
| CHANGE Program | Experimental | Participants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. Receives: Behavioral: The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Participate
Willingness to participate is measured as <30% refusal of study participation from eligible participants. Willingness to participate will be used to measure overall study feasibility.
Measured: Baseline through Week 36 Follow Up
Attendance Rate
The number of participants who attend all study visits. The attendance rate will be used to measure overall study feasibility. A successful attendance rate will be measured as >70% attendance.
Measured: Baseline through Week 36 Follow Up
Percent Homework Adherence
The percentage of participants who complete all homework assignments. Percent homework adherence will be used to measure overall study feasibility. A successful adherence percentage will be measured as >70%.
Measured: Baseline through Week 36 Follow Up
Percent Demonstration of Skills
The percentage of participants who demonstrate skills learned through the CHANGE program. Percent demonstration of skills will be used to measure overall study feasibility. A successful percentage will be measured as >80%.
Measured: Baseline through Week 36 Follow Up
Attrition Rate
The number of participants who do not complete all study visits. The attrition rate will be used to measure study feasibility. An acceptable attrition rate will be considered <15%.
Measured: Baseline through Week 36 Follow Up
Percent Satisfaction
The percentage of participants who report being satisfied with the intervention. Percent satisfaction will be used to measure overall study feasibility. A successful percentage will be measured as >90%.
Measured: Baseline through Week 36 Follow Up
Therapist Fidelity to the Treatment Manual
The percentage of therapists who adhere to the treatment manual. Therapist fidelity will be used to measure overall study feasibility. A successful percentage rate is >80%.
Measured: Baseline through Week 36 Follow Up
Secondary outcomes (4)
Difference in Body Mass Index (BMI) Percentile
The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height.
Measured: Baseline through Week 36 Follow Up
Change in Food Preference Inventory (FPI) Score
The FPI is a 154-item, parent-reported measure of food selectivity. This measure provides important information about which foods the child eats across food groups. A food selectivity score is calculated by dividing the number of foods rated "never" by the total number of foods listed.
Measured: Baseline through Week 36 Follow Up
Change in physical activity
Physical activity will be measured by parent report and average number of steps by Fitbit data.
Measured: Baseline through Week 36 Follow Up
Change in Parenting Stress Index- Short Form (PSI-SF) Score
The PSI-SF is a 36-item survey commonly used measure parental stress. A higher score indicates more parental stress.
Measured: Baseline through Week 36 Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start6 Oct 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Sharp, PhD, Emory University
- Investigators
- William Sharp, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047018
- Sponsor's protocol ID
- IRB00090911
- Status last verified
- Dec 2020
- First submitted
- 7 Feb 2017
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
- ClinicalTrials.gov ID
- NCT03047018
- Acronym / sponsor ID
- IRB00090911
- Conditions
- Autism Spectrum Disorder, Obesity
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 8 Feb 2017 (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 this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
Twenty children with autism spectrum disorder (ASD) who are also overweight will participate in this study at the Marcus Autism Center. All children who enroll will receive the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. This involves 16 sessions over six months. After the six months, participants will come back every month for three months for a follow up visit. Therefore the study will last a total of nine months.
Detailed description
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
This is a 24-week, open trial pilot of 20 children (ages 5 to 12 years old) with ASD and obesity. Subjects will be enrolled in the CHANGE program, a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. After 24 weeks, subjects will be asked to return for follow up assessments at 1, 2 and 3 months later.
The primary aims of this project are to 1) determine the feasibility of the intervention, 2) examine preliminary efficacy, and 3) obtain feedback from parents to improve the effectiveness of the intervention and fit for families.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHANGE Program | Experimental | Behavioral: The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) ProgramParticipants with ASD will complete the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with ASD using DSM-5 criteria, and clinically significant SCQ score.
- Children with mild to moderate food selectivity, as reflected by a) a diet involving at least 6 food items, b) accepting at least one fruit or vegetable as measured by the Food Preference Inventory (FPI), and c) engaging in low mealtime behavior problems on Brief Autism Mealtime Behavior Inventory (BAMBI) Food Refusal subscale
- Child with a clinic-confirmed body mass index (BMI) percentile in the obese range (i.e., > 95th percentile)
- Parent (primary caregiver) who agrees to participate and attend treatment sessions
- Participating parent able to speak, understand, read, and write in English (assessments, curriculum materials and instructions are in English)
Key exclusion criteria (4 listed)
- Children with severe feeding problems (e.g., < 5 preferred foods as measured by the FPI) or complex medical issues (e.g., gastrostomy-tube or formula dependent) who require a different treatment approach
- Children on medication associated with weight gain in ASD (e.g., risperidone) that has not yet stabilized (stability criteria defined as 6 months or longer i.e. child has been on medication for less than 6 months).
- Children with serious behavioral problems (i.e., aggression, tantrums, self-injury) or another psychiatric condition that requires a different treatment approach.
- Children with unstable medical conditions or those with a known associated with weight problems will not be included in this study.
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 |
|---|---|---|
| The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) ProgramThe CHANGE program is a a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. Nutrition intervention focuses on decreasing excess calories from liquids and solids and creating a balanced meal plan. Physical activity intervention uses fading strategies to increase participation in exercise. Behavior strategies promote success with meeting goals. Problem-solving techniques address challenges to adherence with implementing the program in the home setting. The standardized protocols include educational handouts, clinic-based activities and assessment procedures, and caregiver-directed homework and data collection. | Behavioural | CHANGE Program |
Primary outcome
Willingness to Participate
Time frame: Baseline through Week 36 Follow Up
Willingness to participate is measured as <30% refusal of study participation from eligible participants. Willingness to participate will be used to measure overall study feasibility.
Attendance Rate
Time frame: Baseline through Week 36 Follow Up
The number of participants who attend all study visits. The attendance rate will be used to measure overall study feasibility. A successful attendance rate will be measured as >70% attendance.
Percent Homework Adherence
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who complete all homework assignments. Percent homework adherence will be used to measure overall study feasibility. A successful adherence percentage will be measured as >70%.
Percent Demonstration of Skills
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who demonstrate skills learned through the CHANGE program. Percent demonstration of skills will be used to measure overall study feasibility. A successful percentage will be measured as >80%.
Attrition Rate
Time frame: Baseline through Week 36 Follow Up
The number of participants who do not complete all study visits. The attrition rate will be used to measure study feasibility. An acceptable attrition rate will be considered <15%.
Percent Satisfaction
Time frame: Baseline through Week 36 Follow Up
The percentage of participants who report being satisfied with the intervention. Percent satisfaction will be used to measure overall study feasibility. A successful percentage will be measured as >90%.
Therapist Fidelity to the Treatment Manual
Time frame: Baseline through Week 36 Follow Up
The percentage of therapists who adhere to the treatment manual. Therapist fidelity will be used to measure overall study feasibility. A successful percentage rate is >80%.
4 secondary outcomes
Difference in Body Mass Index (BMI) Percentile
Time frame: Baseline through Week 36 Follow Up
Change in Food Preference Inventory (FPI) Score
Time frame: Baseline through Week 36 Follow Up
Change in physical activity
Time frame: Baseline through Week 36 Follow Up
Change in Parenting Stress Index- Short Form (PSI-SF) Score
Time frame: Baseline through Week 36 Follow Up
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 4 Dec 2020.
- Individual participant dataSharing planned: No
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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.
William Sharp, PhD 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 The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program in people with Autism Spectrum Disorder 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 5 inclusion and 4 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 4 Dec 2020. 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?
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?
Willingness to Participate (time frame: Baseline through Week 36 Follow Up). The study lists 7 primary outcomes in all. 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 4 Dec 2020.