iEAT 2.0 Open Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Digestive Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 2/6/2019 |
| Start Date: | November 29, 2017 |
| End Date: | April 2019 |
Evaluation of the Feasibility and Preliminary Efficacy of the Parent-Mediated Integrated Eating Aversion Treatment (iEAT) Manual
The purpose of this study is to learn more about the eating behaviors of children with
chronic food refusal. Specifically, investigator's aim to see how the integrated Eating
Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured
multidisciplinary treatment, including a psychologist and dietitian with consultation from a
speech-language pathologist. The treatment is designed to increase the volume of foods a
child eats and decrease their reliance on a feeding tube or formula. The manual includes
informational handouts, data collection forms, and instructions to guide the increase in
feeding demands while reducing reliance on formula to meet a child's nutritional needs.
Children with chronic food refusal will participate in this study at the Marcus Autism
Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly
sessions that last approximately one hour, over the course of 5 months and a 1 month
follow-up visit. Therefore, the study will last a total of 6 months.
chronic food refusal. Specifically, investigator's aim to see how the integrated Eating
Aversion Treatment (iEAT) may affect a child's food consumption. The manual is a structured
multidisciplinary treatment, including a psychologist and dietitian with consultation from a
speech-language pathologist. The treatment is designed to increase the volume of foods a
child eats and decrease their reliance on a feeding tube or formula. The manual includes
informational handouts, data collection forms, and instructions to guide the increase in
feeding demands while reducing reliance on formula to meet a child's nutritional needs.
Children with chronic food refusal will participate in this study at the Marcus Autism
Center. All children who enroll will receive the iEAT treatment. This involves 10 bi-weekly
sessions that last approximately one hour, over the course of 5 months and a 1 month
follow-up visit. Therefore, the study will last a total of 6 months.
This study seeks to further the development of iEAT by including participants that
demonstrated improvements in a previously conducted pilot study, and finalize the treatment
manual to include the standardized decision rules to increase feeding demands, further
integrate the multidisciplinary team (nutrition and speech pathology), and include
supplementary sessions to better address individual treatment needs.
Investigators propose to enroll participants with chronic food refusal and formula or feeding
tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up
appointment of about 1 hour in length. Assessment and treatment will involve a
multidisciplinary team including behavioral psychology, speech pathology and nutrition.
Target behaviors including grams consumed, percent dependence on formula/feeding tube, and
the clinical global impression scale, which will be assessed during a meal observation, 3-day
food record, and evaluation with the dietitian and independent evaluator. Participants will
be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month
follow-up to assess long term effects.
demonstrated improvements in a previously conducted pilot study, and finalize the treatment
manual to include the standardized decision rules to increase feeding demands, further
integrate the multidisciplinary team (nutrition and speech pathology), and include
supplementary sessions to better address individual treatment needs.
Investigators propose to enroll participants with chronic food refusal and formula or feeding
tube dependence. Treatment will involve 10 biweekly outpatient appointments and 1 follow-up
appointment of about 1 hour in length. Assessment and treatment will involve a
multidisciplinary team including behavioral psychology, speech pathology and nutrition.
Target behaviors including grams consumed, percent dependence on formula/feeding tube, and
the clinical global impression scale, which will be assessed during a meal observation, 3-day
food record, and evaluation with the dietitian and independent evaluator. Participants will
be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month
follow-up to assess long term effects.
Inclusion Criteria:
- Present with partial food refusal as evidenced by greater than 75% of caloric needs
met by bottle, formula, or tube feedings
- Have a medical history significant for an organic factor (e.g., gastrointestinal
issues) which influenced the development of feeding concern
- Safe to consume up to 100% of his/her needs orally
- Parents of subjects must be English literate
- Ability to complete at least 2 structured meals each day
Exclusion Criteria:
- Active medical diagnoses requiring hospitalization or significant oversight from a
physician
- Active medical, structural, or functional limitations preventing safe oral intake of
pureed foods
We found this trial at
1
site
1405 Clifton Road NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-9342
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
Click here to add this to my saved trials
