Caloric Compensation Index (COMPX) Study 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

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 COMPX for eating disorders?

The study on short-term refeeding in adolescents with restrictive eating disorders shows that refeeding, which is a part of nutritional rehabilitation, can improve some meal-related experiences, although not all. This suggests that nutritional interventions can have positive effects on eating disorder symptoms, which may support the potential effectiveness of the COMPX treatment. ^{1 2 3 4 5}

How does the Caloric Compensation Index (COMPX) treatment differ from other treatments for eating disorders?

The Caloric Compensation Index (COMPX) treatment is unique because it focuses on understanding and adjusting the natural feeding patterns and caloric intake of individuals with eating disorders, which can vary significantly from normal patterns. This approach is different from other treatments that may not specifically address the naturalistic feeding behaviors and caloric compensation mechanisms in eating disorders. ^{1 2 5 6 7}

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.

Research Team

Julie Lumeng, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This study is for mother-infant pairs where the child is already part of an ongoing observational study (NCT06039878). It's focused on understanding how emotions, bonding, and eating patterns between a mother and baby are related to feeding habits, the child's eating behaviors, diet, and body fat.

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 test 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

• COMPX

Trial Overview The trial is exploring the Caloric Compensation Index (COMPX), which may help explain biobehavioral connections in how mothers and infants interact with food. The goal is to see if this interaction predicts maternal feeding practices and infant outcomes like eating behavior and weight gain.

Participant Groups

Group I: Caloric Compensation 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 588 adolescents and young adults with eating disorders, males were found to have higher prescribed caloric intake at discharge compared to females, indicating a need for tailored nutritional strategies for different sexes.

Males also experienced greater weight changes and longer hospital stays than females, suggesting that individualized treatment plans are essential for effectively managing eating disorders in young males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in refeeding among hospitalized adolescents and young adults with eating disorders. Nagata, JM., Bojorquez-Ramirez, P., Nguyen, A., et al.[2023]

In a study of 27 women with restricted eating disorders, indirect calorimetry effectively measured resting energy expenditure (REE) and helped monitor recovery during psychonutritional rehabilitation, indicating its usefulness in dietary prescriptions.

The findings showed a positive correlation between arm muscle area and REE, suggesting that as patients gained fat-free mass, their energy expenditure increased, which is a sign of recovery in their eating disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic monitoring of restricted eating disorders by indirect calorimetry: a useful cognitive approach. Dragani, B., Malatesta, G., Di Ilio, C., et al.[2019]

In a long-term follow-up study of 1,351 bulimia nervosa patients, only 38% achieved remission after 11 years, highlighting the need for improved treatment strategies as many patients still experienced significant eating disorder symptoms compared to healthy individuals.

Predictors of poor outcomes included older age at treatment, higher drive for thinness, fewer years of follow-up, and lower global functioning, suggesting that these factors should be considered when developing treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of inpatients with bulimia nervosa-Results from the Christina Barz Study. Quadflieg, N., Fichter, MM.[2019]

Adolescents with newly diagnosed restrictive eating disorders (ED) exhibit significantly altered hunger, fullness, and taste responses compared to healthy controls, indicating that their meal-related experiences are impacted by their condition.

While refeeding improved some aspects of these responses, such as hunger and fullness, it did not fully normalize them, as re-fed individuals still reported lower hunger and greater fullness, along with increased aversive taste perceptions, suggesting ongoing challenges in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of short-term refeeding on appetite and meal experiences in new onset adolescent eating disorders. Peterson, CM., Tissot, AM., Matthews, A., et al.[2020]

Women with bulimia nervosa consumed significantly more calories (4446 kcal) over 24 hours compared to matched controls (1845 kcal), indicating a clear difference in feeding patterns.

The study found that bulimic women often had large meals, particularly in the afternoon and evening, with a notable increase in fat consumption as meal size and total caloric intake rose, highlighting the need for further investigation into the psychological and physiological aspects of their eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding patterns in bulimia nervosa. Weltzin, TE., Hsu, LK., Pollice, C., et al.[2019]

In a study of 225 eating disorder inpatients, caloric restriction (CR) was found to be significantly related to eating symptoms, state anxiety, and body image, indicating that CR is an important factor in understanding eating disorders.

For underweight patients, perfectionistic concerns and state anxiety were identified as key predictors of caloric intake and restriction at discharge, highlighting the need for a comprehensive assessment of psychological factors in treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Caloric Restriction in Inpatients with Eating Disorders: Cross-Sectional and Longitudinal Associations with Body Dissatisfaction, Body Avoidance, Clinical Factors, and Psychopathology. Martini, M., Longo, P., Tamarin, T., et al.[2023]

In a study of 124 female patients with various eating disorders, it was found that all patient groups had significantly lower intake of animal proteins compared to healthy controls, indicating a distinct alteration in food choices associated with these disorders.

The research also revealed that food choices in patients with eating disorders are correlated with psychological symptoms, suggesting that changes in nutrient intake may be influenced by underlying psychological and temperamental factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food choice in disorders of eating behavior: correlations with the psychopathological aspects of the diseases. Segura-García, C., De Fazio, P., Sinopoli, F., et al.[2018]

References

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

Sex differences in refeeding among hospitalized adolescents and young adults with eating disorders. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Dynamic monitoring of restricted eating disorders by indirect calorimetry: a useful cognitive approach. [2019]

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

Long-term outcome of inpatients with bulimia nervosa-Results from the Christina Barz Study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Impact of short-term refeeding on appetite and meal experiences in new onset adolescent eating disorders. [2020]

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

Feeding patterns in bulimia nervosa. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring Caloric Restriction in Inpatients with Eating Disorders: Cross-Sectional and Longitudinal Associations with Body Dissatisfaction, Body Avoidance, Clinical Factors, and Psychopathology. [2023]

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

Food choice in disorders of eating behavior: correlations with the psychopathological aspects of the diseases. [2018]