What side effects are associated with this type of intervention?

Behavioral modification and psychological support for treating picky eating generally do not have the side effects associated with medications. However, they can lead to emotional distress as individuals work to change their eating behaviors, temporary increases in anxiety or stress, and potential resistance or non-compliance. The effectiveness of these therapies can also be influenced by the patient's motivation and the level of support from family and caregivers.

What other types of research exist?

One promising novel alternative for treating picky eating, particularly in the context of ARFID, is the development of specialized study programs aimed at early intervention. These programs are designed to address the unique needs of children with ARFID by focusing on improving their food intake and variety. Additionally, technology-based approaches, such as internet-based cognitive behavioral therapy (ICBT) via videoconference, have shown feasibility and may offer accessible treatment options for patients in remote areas. These innovative methods provide new avenues for treatment beyond traditional behavioral and psychological therapies.

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ARFID Therapies for Picky Eating

Q: What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of picky eating. However, behavioral modification and psychological support are commonly used approaches. These methods focus on changing eating behaviors and addressing underlying psychological factors, similar to the programs being studied for Avoidant/Restrictive Food Intake Disorder (ARFID). These therapies aim to improve dietary habits and overall mental health without relying on pharmacological interventions.

N/A

Waitlist Available

Led By Nancy L Zucker, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Underweight

Child is between 60 and 119 months (5 years and up to 9 years, 11 months)

Must not have

Meets diagnostic criteria for anorexia nervosa or bulimia nervosa

Is currently enrolled in a treatment study or receiving active treatment for ARFID

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-treatment (up to 30 weeks), 3-months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new treatment programs designed to help young children with ARFID, a condition where kids don't eat enough or a variety of foods. The goal is to see if these programs can improve their eating habits and overall health. Timely treatment is crucial to prevent long-term health issues from poor nutrition.

Who is the study for?

This trial is for children aged 5 to almost 10 years with ARFID, who rely on supplements for calories and show significant picky eating. They must be English-speaking and not taking appetite-affecting meds, have no severe intellectual disability or other eating disorders like anorexia or bulimia, and not be in another ARFID treatment study.

What is being tested?

The study tests two programs: Family Assisted Diet (FAD) and Feeling & Body Investigator_ARFID Division, designed to help young kids with ARFID eat better. It aims to find out if these treatments can improve the variety of foods they eat without causing stress.

What are the potential side effects?

Since this trial involves dietary interventions rather than medication, side effects may include initial resistance to new foods or mealtime stress but are expected to be minimal compared to drug-related trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am considered underweight for my height.

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My child is between 5 and 9 years old.

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I have been diagnosed with ARFID.

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I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with anorexia nervosa or bulimia nervosa.

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I am currently in a study or receiving treatment for ARFID.

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I am on medication that affects my appetite.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-treatment (up to 30 weeks), 3-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-treatment (up to 30 weeks), 3-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-treatment (up to 30 weeks), 3-months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)

Secondary study objectives

Body Mass Index (BMI) as measured by height and weight

Nutrition Quality as measured by 3-day 24-hour dietary recalls

Nutrition Quantity as measured by 3-day 24-hour dietary recalls

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Feeling and Body Investigator_ARFID Division (FBI-ARFID)Experimental Treatment1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food.

Group II: Family Assisted Diet (FAD)Active Control1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification and psychological support are common treatments for picky eating, focusing on changing eating behaviors and addressing underlying psychological factors. Behavioral modification involves techniques such as positive reinforcement, exposure to new foods, and structured meal times to encourage healthier eating habits. Psychological support, including cognitive-behavioral therapy (CBT), helps patients address anxiety or negative beliefs about food, improving their overall relationship with eating. These treatments are crucial as they not only promote better nutrition but also reduce the stress and anxiety associated with eating, leading to improved mental and physical health outcomes for picky eating patients.

A practical guide to the treatment of bulimia nervosa.Psychotherapy outcome research with bulimia nervosa.A prospective study of outcome in bulimia nervosa and the long-term effects of three psychological treatments.