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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity. To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

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 data supports the effectiveness of the treatment Eating in Absence of Hunger for eating disorders?

Research shows that interventions like nutritional counseling and behavioral changes can improve eating behaviors in people with eating disorders. Additionally, mindful eating and intuitive eating programs have been found to help individuals become more aware of hunger and fullness cues, leading to positive treatment outcomes. ^{1 2 3 4 5}

Is the Eating Behavior Intervention for Eating Disorders safe for humans?

Research shows that using enteral feeding (feeding through a tube) is safe for patients with eating disorders, and adding mini meals to this feeding method is also considered safe. ^{6 7 8 9 10}

How does the Eating Behavior Intervention for Eating Disorders treatment differ from other treatments?

This treatment is unique because it focuses on addressing 'eating in the absence of hunger' (EAH), a behavior where individuals eat without feeling hungry, which is not typically targeted in standard eating disorder treatments. By adapting the EAH assessment for broader use, this intervention aims to improve self-regulation of eating, which could complement existing therapies like cognitive-behavioral therapy (CBT) that focus on psychological aspects of eating disorders. ^{3 11 12 13 14}

Research Team

Julie Lumeng, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

The researchers will enroll 120 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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does rapid response to two group psychotherapies for binge eating disorder predict abstinence? [2021]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dysfunctional eating in the eating disorders. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Can patients with eating disorders learn to eat intuitively? A 2-year pilot study. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Media Smart-Targeted: Diagnostic outcomes from a two-country pragmatic online eating disorder risk reduction trial for young adults. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Differences between binge eating disorder and nonpurging bulimia nervosa. [2019]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Adapting the Eating in the Absence of Hunger Assessment for Preschoolers in the Classroom Setting. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Perception of hunger to insulin-induced hypoglycemia in anorexia nervosa. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Adiposity and 'eating in the absence of hunger' in children. [2009]

14. Switzerland 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. [2022]