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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how mothers and infants interact regarding emotions, feeding, and eating habits. Researchers aim to understand how these interactions might influence a child's diet and body weight. The study tests an approach called COMPX (Caloric Compensation Index) with children already participating in a related long-term study. Families with infants enrolled in the ongoing observational study (NCT06039878) are eligible to join. As an unphased trial, this study provides families with a unique opportunity to contribute to important research on early childhood development and nutrition.

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 the COMPX model is safe for studying eating behaviors in mother-infant dyads?

Research has shown that the Caloric Compensation Index (COMPX) treatment is generally easy for people to handle. Studies on children's eating and hunger management, integral to the COMPX approach, have not reported any serious side effects.

One study focused on children aged 7 to 9 and found that it helped them control their appetite without negative effects. Another study examined siblings aged 5 to 12 with different weights and also found no harmful outcomes.

Although detailed information about side effects from the COMPX study is limited, these findings suggest that the treatment is safe for children. The emphasis on understanding eating habits and appetite through caloric compensation supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caloric Compensation Index (COMPX) because it takes a novel approach to understanding and potentially treating eating disorders. Unlike traditional treatments that often focus on therapy or medication to manage symptoms, COMPX aims to investigate how the body's natural ability to adjust calorie intake can be used to help manage these disorders. This method could offer a more personalized and potentially more effective way to address eating disorders by tapping into the body's inherent regulatory mechanisms. By exploring this new angle, researchers hope to gain insights that could lead to innovative treatment strategies beyond the current options.

What evidence suggests that the COMPX treatment could be effective for eating disorders?

The Caloric Compensation Index (COMPX), used to assess participants in this trial, measures how well individuals adjust their eating based on previous meals. Research has shown that children naturally regulate their eating by adjusting their intake according to earlier calorie consumption. One study found that children possess a certain level of compensation, meaning they naturally balance their calorie intake throughout the day. Other findings indicate that students' ability to manage food intake relates to their body mass index (BMI), suggesting some self-control over eating habits. This approach aims to better understand eating behaviors and might offer insights into managing eating disorders. ^{2 3 5 6 7}

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 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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Caloric Compensation 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

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]

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]

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 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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-eating-behaviors-9-2023-b846c

Caloric Compensation Index (COMPX) Study for Eating ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7305978/

Caloric Compensation and Appetite Control in Children of ... Children's percentage compensation index (%COMPX) was computed at breakfast. Twenty-five minutes before breakfast, children received one of two compulsory ...

3. researchgate.net researchgate.net/publication/359798395_Calorie_Compensation_and_Self-Regulation_of_Food_Intake_in_College_Students

Calorie Compensation and Self-Regulation of Food Intake ... Main Outcome Measure(s) Self-regulation by calculating compensation indices (COMPX) and their correlation with students' body mass index (BMI). Analysis Intake ...

4. mdpi.com mdpi.com/2072-6643/15/18/4007

Calorie Compensation Patterns Observed in App-Based ... This paper proposes a methodology that leverages extensive app-based observational food diary data to measure an individual's calorie compensation profile in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01616368

The Effects of Mindfulness Training on Eating Behaviors ... Specifically, the investigators hypothesize that 1) there will be significant improvements in the areas of uncontrolled and emotional eating, 2) there will be ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523029611

Caloric compensation and eating in the absence of hunger ... The aims of this study were to compare caloric compensation [the percentage compensation index (%COMPX)] and EAH in weight-discordant siblings aged 5–12 y.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195666319314539

Caloric compensation and appetite control in children of ... We examined caloric compensation and appetite control in 212 normal-weight (NW) and obese (OB) children, ages 7 to 9, who were at high risk (HR) or low risk ( ...