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

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 Relative Reinforcing Value of Food for eating disorders?

The Parent-Based Prevention program, which targets risk factors and facilitates behavioral change in parents, showed improved feeding practices and more positive perceptions of children, suggesting it may help reduce eating and mental problems in children of mothers with eating disorders. This indicates that interventions focusing on parental behavior can positively impact eating disorder outcomes. ^{1 2 3 4 5}

Is the treatment being studied generally safe for humans?

The treatment being studied, a combination of phentermine and topiramate (known as Qsymia), is FDA-approved for obesity and has been evaluated for safety in conditions like binge eating disorder and bulimia nervosa. While topiramate has shown some side effects, the combination aims to improve tolerability and safety. ^{3 6 7 8 9}

How does the Mother-Infant Interaction Study for Eating Disorders treatment differ from other treatments for eating disorders?

This treatment is unique because it focuses on the interactions between mothers with eating disorders and their infants, aiming to address feeding behaviors and attitudes that may affect the child's growth and eating habits. Unlike traditional treatments that focus solely on the individual's eating disorder symptoms, this approach considers the broader impact on mother-child interactions and the potential intergenerational transmission of eating disorders. ^{1 2 10 11 12}

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 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

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

Treatment Details

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.

Participant Groups

Group I: Relative Reinforcing Value 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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

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

Parental eating disorder symptoms and observations of mealtime interactions with children. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Infant feeding behaviours and attitudes to feeding amongst mothers with eating disorders: A longitudinal study. [2019]

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

Self-selection bias in eating disorders outcomes research: Does treatment response of underweight research participants and non-participants differ? [2019]

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

Parent-based prevention program for the children of mothers with eating disorders: Feasibility and preliminary outcomes. [2017]

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

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial. [2021]

6. United States 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. [2023]

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

Research for leveraging food policy in universal eating disorder prevention. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Eating disorders symptoms in pregnancy: a longitudinal study of women with recent and past eating disorders and obesity. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Progress in Developing Pharmacologic Agents to Treat Bulimia Nervosa. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The interactions of mothers with eating disorders with their toddlers: identifying broader risk factors. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Development of a measure of the relative reinforcing value of food versus parent-child interaction for young children. [2021]

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

An empirical taxonomy of reward response patterns in a transdiagnostic eating disorder sample. [2022]