Mother-Infant Interaction 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 explores how the relationship between mothers and their babies might affect eating habits and emotions. It aims to understand how these interactions influence feeding behaviors and the child's overall diet and body composition. The focus is on the "Relative Reinforcing Value of Food," examining how appealing or rewarding food is to the child. Families may be a good fit if their child already participates in a long-term study observing these dynamics. As an unphased study, this trial offers families a unique opportunity to contribute to valuable research that could enhance childhood nutrition and health.

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 Relative Reinforcing Value of Food is safe for the mother-infant dyad?

Research shows that children's desire to eat is linked to how appealing they find food compared to other activities. Studies have found that children who view food as more rewarding often have higher body weight. However, these studies have not identified any safety concerns or negative effects related to food appeal.

The study focuses on understanding eating habits and their motivations, rather than testing a new drug or medical procedure. Therefore, no specific safety risks exist for participating children. Instead, the research aims to learn how food choices and preferences develop over time, particularly in relation to eating disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Relative Reinforcing Value of Food approach because it offers a fresh perspective on understanding eating disorders, particularly in children. Unlike traditional treatments that often focus on therapy or nutritional plans, this method examines how food's appeal or "reinforcing value" influences eating behaviors. By exploring this unique angle, researchers hope to uncover new insights into the mother-infant interaction dynamics that contribute to eating disorders, potentially leading to more effective prevention and intervention strategies. This approach could pave the way for tailored treatments that address the root of the issue rather than just managing symptoms.

What evidence suggests that the Relative Reinforcing Value of Food is effective for mother-infant interaction in eating disorders?

Research shows that understanding how much a child values food compared to other activities can reveal their motivation to eat. Studies have found that this preference links to weight, suggesting it may play a role in obesity. In this trial, researchers will measure how much more a child prefers food over other activities to identify patterns in eating behavior. This method could help detect early signs of eating disorders. Researchers have used it to understand how food choices affect diet quality and energy intake. These insights might lead to better ways to manage and prevent eating problems. ^{3 4 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 behaviors 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 tasks to measure the Relative Reinforcing Value (RRV) of food

Up to approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after the interventional task

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relative Reinforcing Value of Food

Trial Overview The trial is exploring the 'Relative Reinforcing Value of Food' which means it looks at how rewarding food is in the context of a mother-infant relationship. The goal is to see how this affects maternal feeding practices, infant eating patterns, diet quality, and body weight.

How Is the Trial Designed?

Group I: Relative Reinforcing Value 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

A pilot randomized controlled trial tested a manualized Cognitive Behavioral Therapy (CBT) protocol specifically designed for female adolescents with recurrent binge eating, showing significant reductions in binge eating episodes compared to a control group.

All participants in the CBT group were abstinent from binge eating at follow-up, indicating strong efficacy, with a large effect size (NNT=2), suggesting this treatment could be highly effective for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial. Debar, LL., Wilson, GT., Yarborough, BJ., et al.[2021]

In a study involving 23 mother-father pairs with children aged 18 months to 5 years, parental eating disorder symptoms were linked to more controlling feeding behaviors, such as pressuring children to eat and restricting their food intake.

These controlling practices were associated with children eating more food and refusing less, suggesting that parents' eating disorder symptoms may influence their feeding interactions and potentially affect children's eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental eating disorder symptoms and observations of mealtime interactions with children. Blissett, J., Haycraft, E.[2015]

Mothers with eating disorders showed less sensitivity and more controlling behaviors during interactions with their toddlers, which could negatively impact the emotional connection between them.

Toddlers of mothers with eating disorders were observed to be less responsive and exhibited more behavioral problems compared to children of mothers without eating disorders, suggesting broader implications for child development beyond just eating issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interactions of mothers with eating disorders with their toddlers: identifying broader risk factors. Sadeh-Sharvit, S., Levy-Shiff, R., Arnow, KD., et al.[2018]

In a study of 392 underweight adults admitted to an eating disorder treatment program, participants who engaged in research were less likely to leave treatment early and were discharged at a higher BMI compared to non-participants, although the effect size was small.

The transition to partial hospitalization (PH) was a more significant predictor of discharge BMI than research participation, highlighting that treatment completion is crucial for long-term weight maintenance in eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-selection bias in eating disorders outcomes research: Does treatment response of underweight research participants and non-participants differ? Schreyer, CC., Redgrave, GW., Hansen, JL., et al.[2019]

The study developed a new measure to assess the relative reinforcing value (RRV) of food compared to time spent reading with a parent in 4-to-5-year-old children, involving 102 parents in an online survey and 31 parent-child dyads in a laboratory setting.

Findings indicated that children's RRV of food significantly predicted their BMI z-scores, suggesting that higher motivation to eat is associated with increased weight status, while the relationship between reading time and BMI was not significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a measure of the relative reinforcing value of food versus parent-child interaction for young children. Savell, M., Eiden, RD., Kong, KL., et al.[2021]

In a study of 104 individuals with eating disorders (EDs), two distinct reward response profiles were identified: the Behavioral Activation group, which was more likely to seek immediate rewards, and the Behavioral Persistence group, which focused on long-term rewards.

Individuals with binge eating disorder (BED) were more likely to belong to the Behavioral Activation profile, which correlated with higher rates of binge eating and increased body mass index (BMI), suggesting that different reward response patterns may influence the severity and presentation of various eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An empirical taxonomy of reward response patterns in a transdiagnostic eating disorder sample. Haynos, AF., Wang, SB., LeMay-Russell, S., et al.[2022]

The paper emphasizes the need for research on how the food industry influences the risk of eating disorders, highlighting the importance of understanding food production and marketing practices.

It calls for the eating disorder field to engage with food policy and regulation to develop legislative efforts that could reduce the risk of eating disorders by improving the food environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research for leveraging food policy in universal eating disorder prevention. F Rodgers, R., Sonneville, K.[2019]

The Parent-Based Prevention (PBP) program is a feasible intervention for families affected by maternal eating disorders, showing good retention rates among participants.

Preliminary results indicate that PBP leads to improved feeding practices and more positive perceptions of children by parents, potentially reducing the risk of eating and mental health problems in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-based prevention program for the children of mothers with eating disorders: Feasibility and preliminary outcomes. Sadeh-Sharvit, S., Zubery, E., Mankovski, E., et al.[2017]

In a study of 12,254 women, those with a recent history of eating disorders (ED) exhibited higher rates of dieting, laxative use, self-induced vomiting, and exercise during pregnancy compared to other groups, indicating persistent ED symptoms.

Even women with a past history of ED showed some symptoms during pregnancy, suggesting that screening for ED behaviors during this time could help identify those in need of treatment to protect both maternal and fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorders symptoms in pregnancy: a longitudinal study of women with recent and past eating disorders and obesity. Micali, N., Treasure, J., Simonoff, E.[2022]

This study protocol outlines a Phase I/IIa trial involving 30 adults with binge eating disorder (BED) and bulimia nervosa (BN) to evaluate the safety and preliminary efficacy of Qsymia, a combination of phentermine and topiramate, over a 12-week period.

The trial aims to measure the impact of Qsymia on binge eating frequency and related psychological factors, addressing the need for more effective treatments for these eating disorders, as current therapies leave many patients symptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa. Dalai, SS., Adler, S., Najarian, T., et al.[2023]

Women with current and past eating disorders (ED) expressed greater concerns about their infants becoming overweight compared to healthy controls, indicating potential impacts on their feeding behaviors and attitudes.

Mothers with past eating disorders showed less awareness of their infants' hunger and satiety cues, which could affect their child's growth and eating habits, suggesting a risk for intergenerational transmission of eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant feeding behaviours and attitudes to feeding amongst mothers with eating disorders: A longitudinal study. Martini, MG., Taborelli, E., Schmidt, U., et al.[2019]

Currently, the only established medications for bulimia nervosa (BN) are antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), and the antiepileptic drug topiramate, though their effectiveness is only modest.

There is ongoing research into various medications, including fluoxetine and intranasal naloxone, as well as potential new treatments like nociceptin receptor antagonists, indicating a need for further development of specific pharmacological agents for BN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in Developing Pharmacologic Agents to Treat Bulimia Nervosa. McElroy, SL., Guerdjikova, AI., Mori, N., et al.[2020]

Citations

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2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7023996/

The relationships between eating disorder pathology and ... Both the relative reinforcing value (RRV) of food and delay discounting are associated with weight status. While dietary restraint and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195666316307917

Repeatability of the infant food reinforcement paradigm The relative reinforcing value of food versus engagement in other behaviors may be related to the development of obesity, and interventions ...

4. researchgate.net researchgate.net/publication/341389554_Development_of_a_measure_of_the_relative_reinforcing_value_of_food_versus_parent-child_interaction_for_young_children

Development of a measure of the relative reinforcing value ... The relative reinforcing value (RRV) of food captures individual differences in the motivation to eat and is associated with weight status ...

5. mdpi.com mdpi.com/2072-6643/15/9/2179

The Influence of Relative Reinforcing Value of Food ... The purpose of this study was to test the hypothesis that greater RRV and sensitization to HED food is associated with lower diet quality and greater energy ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523273086

Origins of food reinforcement in infants A high relative reinforcing value of food is cross-sectionally related to obesity; lean children find nonfood alternatives more reinforcing than do overweight/ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11344927/

Maternal perspectives on the intergenerational ... Studies indicate that the children of mothers who have eating disorders are at an increased risk of developing eating disorders themselves.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/wps.21263

The current clinical approach to feeding and eating ... Relative reinforcing value of food and delayed reward discounting in obesity and disordered eating: a systematic review. Clin Psychol Rev ...