Feeding DisordersNCT05053438
Evaluating Hunger Manipulation During Feeding Intervention
A study of Feeding Disorders and Feeding and Eating Disorders, run by Emory University at 2 sites in United States.
Trial summary
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for… Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Feeding Disorders, Feeding and Eating Disorders, Avoidant/Restrictive Food Intake Disorder
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2021to 18 Oct 2023
- 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 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be between the ages of 18 months and 6 years of age;
- Present with dependence on enteral feeding for at least 80% of their daily caloric needs; - Have some prior experience consuming food orally;
- Demonstrate safe and functional swallowing;
- Present without neuromuscular conditions who are non-ambulatory (such as cerebral palsy);
- Have a body mass index in the 15th percentile, or greater;
- Present with no evidence of moderate or severe malnutrition (weight for age or BMI of age z-score < -1) or recent weight loss;
Show all 10Show fewer
- Engage in no severe problem behavior outside of mealtimes;
- Have a stable sleep schedule that will not interfere with therapeutic meals throughout the day;
- Caregivers must be English-speaking;
- Caregivers must be present for and participate in all treatment sessions.
Who cannot join
- Individuals with significant active medical conditions requiring oversight from a physician;
- Subjects who display severe problematic behaviors outside of the mealtime, necessitating intervention to specifically address those behaviors; -
- Subjects with medical, structural, or functional limitations preventing safe oral intake of pureed foods;
- Subjects with documented evidence of moderate to severe malnutrition or recent weight loss;
- Individuals with avoidance/restrictive food intake disorders who are not dependent on enteral feedings for at least 80% of their daily caloric needs.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Advanced Pediatrics
Atlanta, Georgia, 30329
Marcus Autism Center
Atlanta, Georgia, 30329
About this study
Official title: Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
Read the detailed description
The recognized standard of care for children dependent on feeding tubes is intensive multidisciplinary feeding intervention (IMFI) involving a professional team that includes psychologists, physicians, nurse practitioners, registered dietitian nutritionists, and speech-language pathologists/occupational therapists working together in inpatient or day hospital settings. A meta-analysis of 11 studies involving intensive, multidisciplinary intervention reported that 71% (95% CI, 54%-83%) of 454 patients successfully weaned from feeding tube dependence at discharge from inpatient or intensive day treatment programs. Treatment gains were maintained following discharge, with 80% (95% CI, 66%-89%) of 414 patients successfully weaned from tube feedings at last follow-up. The most common treatment approaches documented by the meta-analysis involved behavioral intervention and tube weaning (hunger manipulation - evoking a state of hunger to encourage oral consumption by rapidly weaning from the tube). The review highlighted the lack of consensus among clinicians and researchers regarding the criteria for, rate of, and timing of weaning from enteral feedings.
As a result, the authors concluded that the relative contribution of aggressive tube weaning as a standalone or adjunctive therapy to behavioral intervention remains uncertain.
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used as an adjunct to our standard model of behavioral intervention within the study team's IMFI program, for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
- Conditions
- Feeding Disorders, Feeding and Eating Disorders, Avoidant/Restrictive Food Intake Disorder
- Being tested
- Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care, Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning
- Medical subject headings
- Feeding and Eating Disorders, Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of CareBehavioural
Also called Standard of Care, Nutrition
Standard care involves behavioral intervention delivered during admission Intensive Multidisciplinary Intervention. Patients admitted to the program will participate in four therapeutic meals per day, five days per week (Monday through Friday). The behavioral intervention involves a standard sequence of reinforcement techniques, bite persistence (a.k.a., contingency contacting, escape extinction), and stimulus fading/antecedent manipulation protocols. Parent training will be the central method for structuring meals and transferring treatment gains from the clinic to the home setting. The sequence and steps for parents training will follow a sequential, proficiency-based process, with caregivers transitioning to serve as the primary feeder by discharge.
Management of tube wean in our standard of care involves reducing tube feeding calories based on oral intake at a 1:1 ratio.
Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaningBehavioural
Also called Intervention Group, Rapid Tube Weaning
The experimental arm combines standard care with a rapid tube wean. On day 1, the dietitian will meet with the caregiver to determine the usual tube feeding schedule. The dietitian will then create a tube feeding plan that meets 70% of the child's caloric needs (a 30% reduction).On day 3, if a patient has moved past a rice size bite volume in therapeutic meals, the patient's tube feedings will be further reduced to meet 50% of needs. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use a regular tube wean sheet to provide credit for oral intake for the remainder of admission.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Multidisciplinary Intervention (Standard Care) | Active comparator | Children with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals). Receives: Behavioral: Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care |
| Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean) | Experimental | Children with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean.
All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission. Receives: Behavioral: Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of oral intake
The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target.
Measured: Up to 12 months
Percent of patients achieving full wean and time to full wean
% of participants reaching 100% of their caloric needs by mouth
Measured: Measured in days with a time frame of up to 12 months
Secondary outcomes (2)
Change in weight and BMI
Weight will be measured in kilograms (Kg) on a digital scale; height measured in cm; BMI calculated from weight and height into kg/m2, z-score, and percentile
Measured: Up to 12 months
Mealtime performance.
Bite acceptance, rapid swallowing, and inappropriate mealtime behavior
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jul 2021
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DisordersStudies 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
- Model description
- Participants will be randomized 1:1 to intensive feeding intervention (standard care) or intensive feeding intervention (standard care) + rapid tube weaning study groups using permuted blocks of size 2 or 4.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Valerie M. Volkert, Emory University
- Investigators
- Valerie Volket, PhD, BCBA-D, Principal investigator, Emory -Children's Ped Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053438
- Sponsor's protocol ID
- STUDY00002492
- Status last verified
- Nov 2023
- First submitted
- 1 Sep 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to deidentified research data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Hunger Manipulation as an Adjunct to Behavioral Intervention During Intensive Multidisciplinary Feeding Intervention
- ClinicalTrials.gov ID
- NCT05053438
- Acronym / sponsor ID
- STUDY00002492
- Conditions
- Feeding Disorders, Feeding and Eating Disorders, Avoidant/Restrictive Food Intake Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 22 Sep 2021 (actual)
- 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 primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used in an intensive multidisciplinary feeding intervention (IMFI) model of treatment (standard care), for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
Detailed description
The recognized standard of care for children dependent on feeding tubes is intensive multidisciplinary feeding intervention (IMFI) involving a professional team that includes psychologists, physicians, nurse practitioners, registered dietitian nutritionists, and speech-language pathologists/occupational therapists working together in inpatient or day hospital settings. A meta-analysis of 11 studies involving intensive, multidisciplinary intervention reported that 71% (95% CI, 54%-83%) of 454 patients successfully weaned from feeding tube dependence at discharge from inpatient or intensive day treatment programs. Treatment gains were maintained following discharge, with 80% (95% CI, 66%-89%) of 414 patients successfully weaned from tube feedings at last follow-up. The most common treatment approaches documented by the meta-analysis involved behavioral intervention and tube weaning (hunger manipulation - evoking a state of hunger to encourage oral consumption by rapidly weaning from the tube). The review highlighted the lack of consensus among clinicians and researchers regarding the criteria for, rate of, and timing of weaning from enteral feedings.
As a result, the authors concluded that the relative contribution of aggressive tube weaning as a standalone or adjunctive therapy to behavioral intervention remains uncertain.
The primary objective of this study is to determine to what extent hunger provocation, via rapid weaning from enteral feedings, is acceptable and feasible and to evaluate the effect of this intervention when used as an adjunct to our standard model of behavioral intervention within the study team's IMFI program, for individuals with Avoidant Food Intake Disorder (ARFID) who are dependent on enteral feedings to meet their daily caloric needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to intensive feeding intervention (standard care) or intensive feeding intervention (standard care) + rapid tube weaning study groups using permuted blocks of size 2 or 4.
| Arm | Type | Receives |
|---|---|---|
| Intensive Multidisciplinary Intervention (Standard Care) | Active comparator | Behavioral: Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of CareChildren with a history of chronic food refusal will be randomized to receive the standard of care. The standard of care for tube wean is to accomplish the balance between enteral supplementation and oral intake, the tube feeding regimen will follow the schedule of therapeutic meals (e.g., mid-day supplementation occurs after morning therapeutic meals). |
| Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean) | Experimental | Behavioral: Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaningChildren with a history of chronic food refusal will be randomized to receive the experimental arm that combines standard care with rapid tube wean. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use regular tube wean sheet to provide credit for oral intake for remainder of admission. |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Be between the ages of 18 months and 6 years of age;
- Present with dependence on enteral feeding for at least 80% of their daily caloric needs; - Have some prior experience consuming food orally;
- Demonstrate safe and functional swallowing;
- Present without neuromuscular conditions who are non-ambulatory (such as cerebral palsy);
- Have a body mass index in the 15th percentile, or greater;
Key exclusion criteria (5 listed)
- Individuals with significant active medical conditions requiring oversight from a physician;
- Subjects who display severe problematic behaviors outside of the mealtime, necessitating intervention to specifically address those behaviors; -
- Subjects with medical, structural, or functional limitations preventing safe oral intake of pureed foods;
- Subjects with documented evidence of moderate to severe malnutrition or recent weight loss;
- Individuals with avoidance/restrictive food intake disorders who are not dependent on enteral feedings for at least 80% of their daily caloric needs.
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 |
|---|---|---|
| Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of CareAlso: Standard of Care, NutritionStandard care involves behavioral intervention delivered during admission Intensive Multidisciplinary Intervention. Patients admitted to the program will participate in four therapeutic meals per day, five days per week (Monday through Friday). The behavioral intervention involves a standard sequence of reinforcement techniques, bite persistence (a.k.a., contingency contacting, escape extinction), and stimulus fading/antecedent manipulation protocols. Parent training will be the central method for structuring meals and transferring treatment gains from the clinic to the home setting. The sequence and steps for parents training will follow a sequential, proficiency-based process, with caregivers transitioning to serve as the primary feeder by discharge. Management of tube wean in our standard of care involves reducing tube feeding calories based on oral intake at a 1:1 ratio. | Behavioural | Intensive Multidisciplinary Intervention (Standard Care) |
| Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaningAlso: Intervention Group, Rapid Tube WeaningThe experimental arm combines standard care with a rapid tube wean. On day 1, the dietitian will meet with the caregiver to determine the usual tube feeding schedule. The dietitian will then create a tube feeding plan that meets 70% of the child's caloric needs (a 30% reduction).On day 3, if a patient has moved past a rice size bite volume in therapeutic meals, the patient's tube feedings will be further reduced to meet 50% of needs. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use a regular tube wean sheet to provide credit for oral intake for the remainder of admission. | Behavioural | Intensive Multidisciplinary Intervention (Standard Care) + Hunger provocation (Rapid Tube Wean) |
Primary outcome
Change in Percentage of oral intake
Time frame: Up to 12 months
The percent oral intake will be calculated by dividing calories consumed during therapeutic meals by the daily calorie target.
Percent of patients achieving full wean and time to full wean
Time frame: Measured in days with a time frame of up to 12 months
% of participants reaching 100% of their caloric needs by mouth
2 secondary outcomes
Change in weight and BMI
Time frame: Up to 12 months
Mealtime performance.
Time frame: Up to 12 months
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 28 Nov 2023.
- Individual participant dataSharing planned: Yes. Access to deidentified research data.
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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.
Valerie Volket, PhD, BCBA-D principal investigator
Emory -Children's Ped Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Feeding Disorders and Feeding and Eating Disorders, run by Emory University at 2 sites 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 10 inclusion and 5 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Percentage of oral intake (time frame: Up to 12 months). The study lists 2 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 28 Nov 2023.