Trial Outcomes & Findings for An Integrated Nutrition Intervention to Promote Healthy Eating Habits for Children With ASD (NCT NCT05194345)

NCT ID: NCT05194345

Last Updated: 2025-11-19

Results Overview

Change in daily fruit and vegetable intake based on 3-day food records. Daily amount (in cup equivalent) of fruit and vegetable intake from each child participant will be estimated based on parent report 3-day food records. The change amount of fruit and vegetable intake at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Results posted on

2025-11-19

Participant Flow

One family withdrew due to the participant's own medical reason. Providers were trained and implemented the interventions, but outcomes of the study are assessed mainly for children and some for parents. The target number of providers (n=30 targeted) was met (n=32 enrolled).

Participant milestones

Participant milestones
Measure	Autism Eats Nutrition Intervention Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies. The early intervention (EI) providers were trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which will be applied to Autism Eats activities as well. Each intervention lesson will take 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual will be provided to the EI providers and the parent handbook will be distributed to the parent participants. Autism Eats nutrition intervention: The Autism Eats intervention group spent about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The Autism Eats intervention group EI provider spent about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).	We Can! Enhanced Usual Care Control Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. Materials were implemented by the EI providers for 10 weeks (weekly, 10 mins per lesson) and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group spent about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider spent about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Providers Trained for Both Intervention and EUC Control Some providers were trained for both Autism Eats and EUC control programs. The families that they work with were randomly assigned into either group, and the providers were trained for either intervention based on the randomization results.
Overall Study STARTED	64	62	6
Overall Study Children	25	25	0
Overall Study Parents	25	25	0
Overall Study Providers	14	12	6
Overall Study COMPLETED	58	56	6
Overall Study NOT COMPLETED	6	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Autism Eats Nutrition Intervention Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies. The early intervention (EI) providers were trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which will be applied to Autism Eats activities as well. Each intervention lesson will take 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual will be provided to the EI providers and the parent handbook will be distributed to the parent participants. Autism Eats nutrition intervention: The Autism Eats intervention group spent about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The Autism Eats intervention group EI provider spent about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).	We Can! Enhanced Usual Care Control Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. Materials were implemented by the EI providers for 10 weeks (weekly, 10 mins per lesson) and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group spent about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider spent about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Providers Trained for Both Intervention and EUC Control Some providers were trained for both Autism Eats and EUC control programs. The families that they work with were randomly assigned into either group, and the providers were trained for either intervention based on the randomization results.
Overall Study Withdrawal by Subject	6	4	0
Overall Study Moved to another state, becoming ineligible.	0	2	0

Baseline Characteristics

The mean primary outcome data are only from the children (n=50). Parent data are not collected (n=50). Total amount of fruits and vegetables were collected through 3-day food records. Daily total amount of fruits and vegetables is the mean of those across three days. Therefore, the mean cup equivalents is used as the unit of measure. Cup equivalents is used based on the data generated with the ASA24.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autism Eats Nutrition Intervention: Children n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads participate in the intervention as part of their regular EI services. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview).	We Can! Enhanced Usual Care Control: Children n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. Materials were implemented by the EI providers for 10 weeks (weekly, 10 mins per lesson) and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule).	Autism Eats Nutrition Intervention: Parents n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview).	We Can! Enhanced Usual Care Control: Parents n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. Materials were implemented by the EI providers for 10 weeks (weekly, 10 mins per lesson) and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule).	Autism Eats Nutrition Intervention: Providers n=14 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies. The early intervention (EI) providers are trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The EI providers spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).	We Can! Enhanced Usual Care Control: Providers n=12 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. Materials were implemented by the EI providers for 10 weeks (weekly, 10 mins per lesson) and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule).	Providers Trained for Both Intervention and EUC Control n=6 Participants Some providers were trained for both Autism Eats intervention and EUC control programs and implemented them based on each family's assigned condition.	Total n=132 Participants Total of all reporting groups
Age, Categorical Parent (18 and 65 years) and children (<=18 years) dyads · <=18 years	25 Participants n=25 Participants	25 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	50 Participants n=132 Participants
Age, Categorical Parent (18 and 65 years) and children (<=18 years) dyads · Between 18 and 65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	14 Participants n=14 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	82 Participants n=132 Participants
Age, Categorical Parent (18 and 65 years) and children (<=18 years) dyads · >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=132 Participants
Sex: Female, Male Female	6 Participants n=25 Participants	5 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	14 Participants n=14 Participants	12 Participants n=12 Participants	6 Participants n=6 Participants	93 Participants n=132 Participants
Sex: Female, Male Male	19 Participants n=25 Participants	20 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	39 Participants n=132 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=25 Participants	12 Participants n=25 Participants	8 Participants n=25 Participants	12 Participants n=25 Participants	5 Participants n=14 Participants	4 Participants n=12 Participants	4 Participants n=6 Participants	53 Participants n=132 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=25 Participants	13 Participants n=25 Participants	17 Participants n=25 Participants	13 Participants n=25 Participants	9 Participants n=14 Participants	8 Participants n=12 Participants	2 Participants n=6 Participants	79 Participants n=132 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=132 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	1 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	2 Participants n=132 Participants
Race (NIH/OMB) Asian	3 Participants n=25 Participants	1 Participants n=25 Participants	3 Participants n=25 Participants	1 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	8 Participants n=132 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=14 Participants	0 Participants n=12 Participants	0 Participants n=6 Participants	0 Participants n=132 Participants
Race (NIH/OMB) Black or African American	2 Participants n=25 Participants	7 Participants n=25 Participants	3 Participants n=25 Participants	6 Participants n=25 Participants	2 Participants n=14 Participants	1 Participants n=12 Participants	1 Participants n=6 Participants	22 Participants n=132 Participants
Race (NIH/OMB) White	11 Participants n=25 Participants	12 Participants n=25 Participants	15 Participants n=25 Participants	15 Participants n=25 Participants	7 Participants n=14 Participants	6 Participants n=12 Participants	5 Participants n=6 Participants	71 Participants n=132 Participants
Race (NIH/OMB) More than one race	9 Participants n=25 Participants	4 Participants n=25 Participants	4 Participants n=25 Participants	2 Participants n=25 Participants	2 Participants n=14 Participants	1 Participants n=12 Participants	0 Participants n=6 Participants	22 Participants n=132 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	3 Participants n=14 Participants	4 Participants n=12 Participants	0 Participants n=6 Participants	7 Participants n=132 Participants
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	25 participants n=25 Participants	25 participants n=25 Participants	14 participants n=14 Participants	12 participants n=12 Participants	6 participants n=6 Participants	132 participants n=132 Participants
Total amount of fruits and vegetables	1.5902 cup equivalents STANDARD_DEVIATION 0.9774 • n=25 Participants • The mean primary outcome data are only from the children (n=50). Parent data are not collected (n=50). Total amount of fruits and vegetables were collected through 3-day food records. Daily total amount of fruits and vegetables is the mean of those across three days. Therefore, the mean cup equivalents is used as the unit of measure. Cup equivalents is used based on the data generated with the ASA24.	1.3807 cup equivalents STANDARD_DEVIATION 0.9764 • n=25 Participants • The mean primary outcome data are only from the children (n=50). Parent data are not collected (n=50). Total amount of fruits and vegetables were collected through 3-day food records. Daily total amount of fruits and vegetables is the mean of those across three days. Therefore, the mean cup equivalents is used as the unit of measure. Cup equivalents is used based on the data generated with the ASA24.	—	—	—	—	—	1.4854 cup equivalents STANDARD_DEVIATION 0.9726 • n=50 Participants • The mean primary outcome data are only from the children (n=50). Parent data are not collected (n=50). Total amount of fruits and vegetables were collected through 3-day food records. Daily total amount of fruits and vegetables is the mean of those across three days. Therefore, the mean cup equivalents is used as the unit of measure. Cup equivalents is used based on the data generated with the ASA24.

PRIMARY outcome

Timeframe: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Population: Outcome data were only assessed for children. Mean changes of daily amount of fruits and vegetables were calculated. Daily mean intake was used because the data were collected from 3-day food records. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for child age, sex, race, and ethnicity.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children The change amount of fruit and vegetable intake at post- from the baseline	-0.045 cup equivalents Interval -0.842 to 0.752	0.313 cup equivalents Interval -1.511 to 0.413
Change in Fruit and Vegetable Intake From Baseline, as Measured by the Daily Amount of Fruit and Vegetables Consumed by Children The change amount of fruit and vegetable intake at 5-month follow-up from the baseline	-0.077 cup equivalents Interval -1.024 to 0.87	0.549 cup equivalents Interval -0.413 to 1.511

PRIMARY outcome

Timeframe: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Population: Number of foods from the 3-day food records entered into the ASA24. Food codes in ASA24 represent unique food items, therefore we estimated daily food codes reported on 3-day food records over time. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for child age, sex, race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

Change in daily food counts based on 3-day food records. Daily number of food items from each child participant will be estimated based on parent report 3-day food records. The change in number of daily food items at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Food Variety From Baseline, as Measured by the Daily Food Counts Consumed by Children The change in number of foods at 5-month follow-up from the baseline	-0.726 number of unique food codes per day Interval -3.614 to 2.161	-0.031 number of unique food codes per day Interval -3.027 to 2.965
Change in Food Variety From Baseline, as Measured by the Daily Food Counts Consumed by Children The change in number of foods at post- from the baseline	-0.362 number of unique food codes per day Interval -2.695 to 1.972	0.856 number of unique food codes per day Interval -1.615 to 3.328

PRIMARY outcome

Timeframe: baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Population: Healthy Eating Index (HEI-2015) was calculated based on the 3-day food records. Mean HEI scores were calculated. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for child age, sex, race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

Change in HEI score based on 3-day food records. Daily mean HEI score from each child participant will be estimated based on parent report 3-day food records. The change in HEI score at post- from the baseline and at 5-month follow-up from the baseline will be compared between the intervention and the enhanced usual care (EUC) control groups. HEI score ranges 0-100, and higher values represent a better outcome (better diet quality).

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Diet Quality From Baseline, as Measured by Mean Healthy Eating Index (HEI) Score From the Food Records. HEI Score Ranges From 0 to 100. The change in HEI total score at post- from the baseline	-0.510 scores on a scale Interval -0.8073 to 7.052	-2.179 scores on a scale Interval -10.043 to 5.685
Change in Diet Quality From Baseline, as Measured by Mean Healthy Eating Index (HEI) Score From the Food Records. HEI Score Ranges From 0 to 100. The change in HEI total score at 5-month follow-up from the baseline	-0.589 scores on a scale Interval -9.653 to 8.476	-1.079 scores on a scale Interval -10.334 to 8.177

PRIMARY outcome

Timeframe: Baseline, post-intervention (10 weeks from baseline), and 5-month follow-up

Population: The higher score represents more problematic mealtime behaviors. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for child age, sex, race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

The Brief Autism Mealtime Behavior Inventory (BAMBI), which is validated and used in many previous research studies to assess children with ASD's problematic mealtime behaviors. Parents completed the survey via REDCap. The BAMBI contains 18 questions using a 5-point scale, with response options ranging from 1 (Never) to 5 (Almost every meal), for reporting the frequency of a behavior. The total score ranges from 18-90. The higher the score indicated more problematic mealtime behaviors (worse). Each question also has a yes or no option for parents to indicate if they perceive the behaviors as problematic (score range 0-18). There are subscales: Limited Variety, Food Refusal, and Features of Autism. The Limited Variety scale includes 8 items, with a score range of 8-40. The Food Refusal scale has 5 items, with a 5-25 score range. The Features of Autism includes 5 items with a 5-25 score range. The total score is the sum of all scores. The survey takes about 5 minutes to complete.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI mealtime behavior total scores (range 18-90) at post- from the baseline	-4.268 score on a scale Interval -10.691 to 2.154	-5.151 score on a scale Interval -11.353 to 1.051
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI mealtime behavior total scores at 5-month follow-up from the baseline	-4.267 score on a scale Interval -11.038 to 2.504	-3.413 score on a scale Interval -9.894 to 3.068
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Limited Variety sub-scores (range 8-40) at post- from the baseline	-2.269 score on a scale Interval -5.866 to 1.329	-0.499 score on a scale Interval -3.973 to 2.975
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Limited Variety sub-scores (range 8-40) at 5-month follow-up from the baseline	-1.597 score on a scale Interval -5.39 to 2.196	0.818 score on a scale Interval -2.812 to 4.448
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Food Refusal sub-scores (range 5-25) at post- from the baseline	-1.405 score on a scale Interval -4.153 to 1.342	-2.667 score on a scale Interval -5.32 to -0.014
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Food Refusal sub-scores (range 5-25) at 5-month follow-up from the baseline	-1.882 score on a scale Interval -4.778 to 1.015	-1.785 score on a scale Interval -4.558 to 0.987
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Features of Autism sub-scores (range 5-25) at post- from the baseline	-0.594 score on a scale Interval -2.931 to 1.742	-1.985 score on a scale Interval -4.241 to 0.272
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Features of Autism sub-scores (5-25) at 5-month follow-up from the baseline	-0.789 score on a scale Interval -3.252 to 1.675	-2.446 score on a scale Interval -4.804 to -0.088
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Number of Problems sub-scores (0-18) at post- from the baseline	-0.056 score on a scale Interval -3.227 to 3.115	-2.831 score on a scale Interval -5.893 to 0.232
Change in Mealtime Behaviors, as Measured by Total Score of the Brief Autism Mealtime Behavior Inventory (Score Ranges 5-90). The change in BAMBI Number of Problems sub-scores (0-18) at 5-month follow-up from the baseline	-1.587 score on a scale Interval -4.93 to 1.757	-3.006 score on a scale Interval -6.206 to 0.194

SECONDARY outcome

Timeframe: Baseline, 5-month follow-up

Population: Change in WFL or BMI percentile for children with ASD at 5-month follow-up from baseline. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

Parents will be given options for their child's anthropometric assessments. They can come to the USF office and get children's height and weight measured by a trained research assistant (RA) or a RA can visit participants' house to use a portable stadiometer and a weight scale. If only virtual height and weight measurement is accessible (due to the COVID-19 pandemic), a metal ruler and a bathroom weight scale will be sent to the participant's house and a RA instructed assessment will be virtually completed. As a standard weight status assessment for birth to 36 months, weight-for-length percentile for under 2 years and BMI percentile for 2 years or older will be calculated based on the CDC growth chart.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Child's Weight-for-length/BMI Percentile (Calculated With Height & Weight), as Measured by Percentile on the CDC Weight-for-length/BMI-for-age Growth Chart.	-2.653 Weight-for-length/BMI percentiles Interval -23.469 to 18.163	-10.475 Weight-for-length/BMI percentiles Interval -29.742 to 8.793

SECONDARY outcome

Timeframe: Baseline, 5-month follow-up

Population: Parental feeding practice questionnaire (child feeding questionnaire - CFQ) at 5-month follow-up from baseline. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

Items are measured using a five-point Likert-type scale. Parental beliefs and attitudes regarding child feeding practices are measured in seven domains; perceived responsibility (mean of 3 items), parent perceived weight (mean of 4 items), perceived child weight (mean of 3 items), parents' concerns about child weight (mean of 3 items), monitoring (mean of 3 items), restriction (mean of 8 items), pressure to eat (mean of 4 items). Mean scores of each domain are calculated at each time point. The possible range is 1-5 for all seven domains. High scores represent greater perceived responsibility, higher perceived weight, more concerns about child weight, more feeding practices of monitoring, restriction, and pressure to eat. Higher parental concerns is likely to be associated with more controlling parent feeding practices (higher scores in monitoring, restriction, and pressure to eat), which, in turn, relate to worse/poorer dietary behaviors and health outcomes.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Concerns about Child's Weight subscale scores at 5-month follow-up from the baseline	-.337 score on a scale Interval -1.295 to 0.621	-.397 score on a scale Interval -1.261 to 0.468
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Restriction subscale scores at 5-month follow-up from the baseline	.140 score on a scale Interval -0.719 to 0.998	.064 score on a scale Interval -0.711 to 0.839
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Pressure-To-Eat subscale scores at 5-month follow-up from the baseline	-.087 score on a scale Interval -0.941 to 0.766	-.201 score on a scale Interval -0.971 to 0.57
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Monitoring subscale scores at 5-month follow-up from the baseline	.348 score on a scale Interval -0.866 to 1.563	.090 score on a scale Interval -1.006 to 1.186
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Feeding Responsibility subscale scores at post-intervention from baseline	0.034 score on a scale Interval -0.435 to 0.503	-0.214 score on a scale Interval -0.685 to 0.258
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Concerns about Child's Weight subscale scores at post-intervention from baseline	-0.484 score on a scale Interval -1.31 to 0.343	-0.299 score on a scale Interval -1.131 to 0.532
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Restriction subscale scores at post-intervention from baseline	0.433 score on a scale Interval -0.308 to 1.174	0.088 score on a scale Interval -0.657 to 0.833
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Pressure-To-Eat subscale scores at post-intervention from baseline	0.177 score on a scale Interval -0.56 to 0.913	-0.670 score on a scale Interval -1.411 to 0.071
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Monitoring subscale scores at post-intervention from baseline	0.040 score on a scale Interval -1.008 to 1.088	0.433 score on a scale Interval -0.62 to 1.487
Change in Child Feeding Practices, as Measured in Mean on the Child Feeding Questionnaire Using a 5-point Scale. Change in CFQ Feeding Responsibility subscale scores at 5-month follow-up from the baseline	-0.003 score on a scale Interval -0.546 to 0.541	-0.065 score on a scale Interval -0.556 to 0.425

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 5-month follow-up

Population: Change in parent BMI at 5-month follow-up from baseline. Linear mixed-effects models (LMMs) were conducted using restricted maximum likelihood (REML) estimation to evaluate the effects of the intervention and time interaction on the outcome, adjusting for child age, sex, race, and ethnicity. Least Squared Mean and 95% CI are reported from the output.

Parent height and weight will be assessed by a trained research assistant or it will be self-reported via REDCap survey. Parent height will be measured with a stadiometer and weight will be measured on a scale. If they are unavailable for assessment, data will be self-reported. Parent BMI (kg/m²) will be calculated and used as a covariate/mediator in data analyses.

Outcome measures

Outcome measures
Measure	We Can! Enhanced Usual Care Control n=25 Participants Enhanced usual care (EUC) control group materials are from the evidence-based materials that are already developed and available online (in both English and Spanish): https://www.nhlbi.nih.gov/health/educational/wecan/index.htm. We will download one to two handouts and email early intervention providers to distribute them to parent-child dyads. Materials will be distributed each week for 10 weeks and additional monthly handouts for two months after the first 10 weeks (parallel to the intervention schedule). We Can! enhanced usual care: We Can! EUC control group will spend about 3 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, one 25-30 minute nutrition session, and a 60-minute exit interview). We Can! EUC control group EI provider will spend about 4.5 hours over 5 months (two 90-minutes training sessions, one 25-30 minutes session, 1-2-minute written material distribution at their 9 weekly EI sessions, and a 60-minute exit interview).	Autism Eats Nutrition Intervention n=25 Participants Autism Eats intervention lessons (10 lessons + 2 booster sessions) integrate ASD-specific feeding strategies such as repeated exposures, food chaining, and making regular mealtime routines and behaviorally-focused nutrition content and activities utilizing goal setting, healthy meal planning, monitoring progress, strategies to overcome barriers, and creating healthy home food environment. The early intervention (EI) providers will be trained to implement the lessons. EI providers are well-trained to use personalized intervention and coaching approach in their EI services, which are applied to Autism Eats activities as well. Each intervention lesson takes 25-30 minutes within one hour EI services, and parent-child dyads will participate in the intervention as part of their regular EI services. The Autism Eats lesson manual is provided to the EI providers and the parent handbook is distributed to the parent participants. The Autism Eats intervention group spends about 8.5 hours over 5 months (baseline, post intervention, and 5-month follow-up assessments are 30 minutes each, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, and a 60-minute exit interview). The EI provider spend about 12 hours over 5 months (two 90-minutes training sessions, 25-30 minutes weekly sessions for up to 10 weeks, two 25-30 minutes monthly booster sessions, 10-minute fidelity checklist completion after each session, and a 60-minute exit interview).
Parent BMI, as Measured in kg/m² Calculated From Height (m) and Weight (kg).	-.987 kg/m^2 Interval -8.259 to 6.285	.908 kg/m^2 Interval -5.67 to 7.487

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heewon Gray

University of South Florida

Phone: (813) 974-9881

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place