Eating Behavior Intervention for Eating Disorders

Overseen By Alex Jeanpierre

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not enrolled in NCT06039878

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the development of emotions, attachment, and eating habits between mothers and their infants. Researchers seek to determine how these interactions influence a mother's feeding practices, the child's eating habits, and their body weight over time. The study observes children already participating in a specific long-term observational study. Children in that study may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute valuable insights into early childhood development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for participants?

Research shows that "Eating in the Absence of Hunger," which means eating when not hungry, is linked to higher body weight and obesity. Although this behavior can lead to weight gain, the study aims to understand eating patterns, not to test a new drug or perform surgery.

Regarding safety, since the study involves no medication or surgery, the risk of physical harm remains low. Researchers will observe eating habits and emotions, so participants will not encounter any risky treatments.

In summary, the study focuses on understanding eating behaviors, ensuring safety from a physical standpoint. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Eating in Absence of Hunger" intervention because it takes a unique approach to addressing eating disorders by focusing on behavioral patterns rather than medication. Unlike traditional treatments that often involve therapy or medication to manage symptoms, this method aims to understand and modify eating behaviors directly. By enrolling children from a long-term study, this intervention could provide new insights into how eating habits form and change, potentially leading to more effective and personalized strategies for managing eating disorders.

What evidence suggests that this intervention might be effective for eating disorders?

Research has shown that eating when not hungry, known as eating in the absence of hunger (EAH), is a key behavior linked to binge-eating disorder (BED) in young people. This behavior is crucial to study because it often leads to overeating, even without physical hunger, contributing to eating disorders. Studies have found that children who eat when not hungry are more likely to develop unhealthy eating habits and potential weight problems. This trial will focus on EAH as a single treatment arm to understand and address this behavior. Early findings suggest that targeting EAH could improve eating habits and health outcomes in affected children. ^{1 5 6 7 8}

Who Is on the Research Team?

Julie Lumeng, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This study is for mothers and their infants who are already part of an observational study (NCT06039878). It aims to understand how emotions, bonding, and feeding patterns between mother and baby relate to the child's eating habits and weight.

Inclusion Criteria

The child is a participant in the observational study (NCT06039878).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interventional Task

Children participate in an interventional task to study biobehavioral mechanisms related to emotion, attachment, and nutritive intake

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the interventional task

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eating in Absence of Hunger

Trial Overview

The trial investigates a model that links emotional bonds, attachment, and feeding in the mother-infant relationship with how mothers feed their children, the child’s eating behaviors, diet quality, and body fat levels.

How Is the Trial Designed?

Group I: Eating in the Absence of Hunger (single arm) Experimental Treatment 1 Intervention

The researchers will enroll 150 children from the long-term observational study, NCT06039878.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Media Smart-Targeted (MS-T) program significantly reduced the likelihood of eating disorder (ED) onset by 66% in young-adult women compared to a control group, although this result was not statistically significant.

For participants who already met ED criteria at the start of the study, the MS-T program led to a 75% reduction in the likelihood of still meeting diagnostic criteria at the 12-month follow-up, demonstrating its effectiveness as a treatment intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Media Smart-Targeted: Diagnostic outcomes from a two-country pragmatic online eating disorder risk reduction trial for young adults. Wilksch, SM., O'Shea, A., Wade, TD.[2018]

Eating in the absence of hunger (EAH) is positively associated with higher levels of adiposity in boys, as shown in two studies involving 664 children aged 7-12 years, indicating that EAH is linked to weight status across different weight categories.

In girls, the association between EAH and adiposity was less clear, suggesting that social factors may influence eating behaviors, particularly in heavier girls, who may feel pressured to conform to societal expectations regarding food intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adiposity and 'eating in the absence of hunger' in children. Hill, C., Llewellyn, CH., Saxton, J., et al.[2009]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

In a study involving 4,646 women, those recruited through media channels showed higher symptom severity related to disordered eating compared to those recruited face-to-face, indicating that media recruitment may attract individuals at greater risk for anorexia nervosa.

Participants recruited via media not only met the inclusion criteria more frequently but also engaged more with the intervention program, suggesting that media-based recruitment is a more effective strategy for reaching at-risk individuals for preventive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruiting participants to an Internet-based eating disorder prevention trial: Impact of the recruitment strategy on symptom severity and program utilization. Vollert, B., von Bloh, P., Eiterich, N., et al.[2021]

In a study comparing 45 nonpurging bulimics and 45 binge eating disorder (BED) patients, it was found that 89% of nonpurging bulimics reported that their binge eating was preceded by dieting and weight loss, indicating a more structured pathway to their eating behavior.

BED patients exhibited a more variable pathway to binge eating and had a significantly lower frequency of previous anorexia nervosa episodes compared to nonpurging bulimics, suggesting that BED may represent a more heterogeneous group in terms of clinical characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between binge eating disorder and nonpurging bulimia nervosa. Santonastaso, P., Ferrara, S., Favaro, A.[2019]

Introducing mini meals into a 7-day enteral feeding protocol for patients with eating disorders was found to be safe, with no clinical incidents reported among the 64 participants studied.

Participants generally accepted the mini meals, with 54% reporting an improved experience, although some expressed a desire for more menu choices to enhance consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding mini meals to a nasogastric refeeding protocol for patients with eating disorders can be achieved on general hospital wards. Morgan, K., Cutmore, C., Matthews-Rensch, K.[2023]

In a study of 101 adults with binge eating disorder, those who showed a rapid response (≥65% reduction in binge eating by week 4) had significantly higher rates of binge eating abstinence at both end-of-treatment (70.7% vs. 33.3%) and one year follow-up (70.7% vs. 40.0%).

Rapid responders also experienced lower treatment attrition rates, and the benefits of rapid response were more pronounced in those receiving Dialectical Behavior Therapy for BED compared to the active comparison group therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does rapid response to two group psychotherapies for binge eating disorder predict abstinence? Safer, DL., Joyce, EE.[2021]

The study successfully adapted the Eating in the Absence of Hunger (EAH) assessment for preschoolers in classroom settings, demonstrating that it is feasible, economical, and time-efficient for broader use.

Challenges included selecting compliant and appealing snacks and managing prior meal control, but overcoming these barriers can enhance future research on EAH in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Adapting the Eating in the Absence of Hunger Assessment for Preschoolers in the Classroom Setting. Soltero, EG., Ledoux, T., Lee, RE.[2018]

Problems with hunger and appetite regulation in anorexia and bulimia nervosa can persist even after treatment, indicating that current treatment goals may not fully address these issues.

Nutritional counseling and behavioral interventions have shown positive outcomes in improving eating behaviors, suggesting that integrating these approaches into treatment could enhance recovery from eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctional eating in the eating disorders. Hetherington, MM., Rolls, BJ.[2019]

The Eating Disorder Diagnostic Scale (EDDS) has demonstrated strong reliability and validity in a clinical population of 59 female patients with eating disorders, making it a useful tool for diagnosing conditions like anorexia nervosa and bulimia nervosa.

A cut-off score of 16.5 on the EDDS effectively differentiates clinical patients from healthy controls, indicating its potential application in clinical settings and research related to eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Eating Disorder Diagnostic Scale: psychometric features within a clinical population and a cut-off point to differentiate clinical patients from healthy controls. Krabbenborg, MA., Danner, UN., Larsen, JK., et al.[2022]

A 10-week Mindful Eating Group intervention for 33 individuals with various eating disorders led to significant reductions in disordered eating symptoms, as measured by the EAT-26, with large effect sizes.

The study suggests that incorporating mindfulness practices can be beneficial as an additional treatment for different types of eating disorders, regardless of the specific diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindful eating group as an adjunct to individual treatment for eating disorders: a pilot study. Hepworth, NS.[2017]

A 2-year pilot study at an eating disorder treatment center showed that patients can successfully learn intuitive eating skills, which are linked to positive treatment outcomes across various eating disorder diagnoses.

The study suggests that incorporating intuitive eating training into inpatient and residential treatment programs can be done safely and effectively, enhancing overall patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can patients with eating disorders learn to eat intuitively? A 2-year pilot study. Richards, PS., Crowton, S., Berrett, ME., et al.[2017]

In a study involving 34 females, including 17 with restricting anorexia nervosa (AN-R) and 6 who had undergone cognitive-behavioral therapy (AN-T), insulin-induced hypoglycemia led to a significant increase in hunger ratings in healthy controls, but a paradoxical decrease in AN-R patients.

The findings indicate that anorectic patients have a disturbed perception of hunger in response to insulin-induced hypoglycemia, suggesting potential challenges in their physiological hunger signaling even after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of hunger to insulin-induced hypoglycemia in anorexia nervosa. Nakai, Y., Koh, T.[2019]

The paper identifies three psychological models—Dietary Restraint Theory, Emotional Eating, and the Diathesis-Stress Model—that influence eating behaviors in obese children, providing a framework for understanding these behaviors.

A consensus-based three-staged assessment approach is proposed, along with valid and reliable tools for evaluating these models in clinical practice, aiming to improve the management of eating behaviors in children who are obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment of eating behaviour in children who are obese: a psychological approach. A position paper from the European childhood obesity group. Braet, C., O'Malley, G., Weghuber, D., et al.[2022]

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