440 Participants NeededMy employer runs this trial

Feeding Interventions for Childhood Obesity

(BOTTLE Trial)

BC
Overseen ByBryanne Caldwell
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different bottle nipple flow rates influence the amount of milk babies consume, their feeding habits, and their sleep. Researchers aim to determine if adjusting the flow rate can help manage and potentially prevent childhood obesity. Eligible participants are mothers with infants aged 4 to 6 months who bottle-feed at least once a week and reside near Ann Arbor, Michigan. The goal is to assess whether feeding interventions can encourage healthier growth patterns in infants. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could promote healthier growth in infants.

What prior data suggests that these feeding interventions are safe for infants?

Research has shown that altering how babies are fed, such as using different bottle nipple flow rates, impacts childhood obesity. These changes are generally safe. For instance, studies on early feeding habits have provided strong evidence that they can reduce obesity risk without major safety concerns. Feeding practices that promote healthy growth in babies typically yield positive results and are well-tolerated. Thus, similar changes are unlikely to cause harm and can safely encourage healthy eating habits.12345

Why are researchers excited about this trial?

Unlike traditional treatments for childhood obesity that often focus on diet plans or exercise regimes, this feeding intervention is unique because it targets the mother-infant relationship directly. Researchers are excited about this approach as it allows each mother-infant pair to serve as its own control, offering a personalized insight into how feeding practices can be optimized for each unique duo. This method could potentially foster healthier eating habits from the earliest stages of life, offering a proactive strategy to combat childhood obesity before it becomes a more significant issue.

What evidence suggests that this feeding intervention is effective for childhood obesity?

Research has shown that feeding programs can help address childhood obesity. This trial uses a mother-infant dyad approach, with each dyad serving as its own control. Studies have found that multi-component programs, including teaching children to eat in response to hunger, can have small but positive effects. These programs help regulate children's food intake, supporting a healthy weight. Other studies suggest that establishing healthy eating habits early can reduce the risk of obesity in young children. Overall, feeding programs are promising tools for addressing childhood obesity by shaping eating habits and food intake.36789

Who Is on the Research Team?

AC

Amanda Crandall, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for babies who are bottle-fed. There are no specific inclusion or exclusion criteria listed, but it focuses on infants and their feeding habits.

Inclusion Criteria

Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions
Gestational age: Infant was born at 37.0-42.0 weeks gestation
Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody)
See 5 more

Exclusion Criteria

I currently have depression, anxiety, or cognitive issues that affect my daily functioning.
My child has a condition that affects their eating, growth, or development.
History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline

Establish baseline feeding patterns and milk intake using typical bottle nipples

3 days

Slower Flow Feeding

Participants use slower-flow bottle nipples to assess changes in milk intake and feeding patterns

4 days

Follow-up

Participants are monitored for changes in feeding patterns and satiation signaling after the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Feeding

Trial Overview

Researchers are testing how different bottle nipple flow rates affect the amount of milk babies drink, their feeding patterns, and sleep over a few days.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mother-infant dyadExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Interventions for Childhood Central Obesity - PMC - NIH

Five trials included exclusively on behavioral interventions focusing on dietary education to reduce unhealthy snacks, increase fruit and ...

Effectiveness of Interventions During Early Childhood to ...

Evidence suggests that multicomponent interventions incorporating physical activity or responsive feeding show modest positive effects, although ...

The effectiveness of school-based obesity prevention ...

There was evidence to suggest that obesity prevention interventions had a positive effect on fruit and vegetable intake with nine studies out of 10 (90 %) ...

Assessing the impact of obesity interventions in the early ...

Findings from this review suggest that interventions that promote healthy growth in the early years could be effective in reducing the risk of obesity as part ...

Effectiveness of School-Based Nutritional Interventions in ...

Conclusion: School-based nutritional interventions are effective in reducing obesity and promoting healthier dietary behaviors among children.

Family-Based Interventions Targeting Childhood Obesity - PMC

The majority of the studies, 70%, showed statistically significant moderate to large effect size changes in child BMI, after participating in a family-based ...

Caregiver feeding practices and child weight outcomes

Restrictive feeding practices are associated with increased weight gain and higher weight status, and pressuring feeding practices are associated with decreased ...

Outcomes of an Early Feeding Practices Intervention to ...

The goal of this study was to evaluate outcomes of a universal intervention to promote protective feeding practices that commenced in infancy ...

Preventing Childhood Obesity – Eating Better, Moving More

Nearly 1 in 5 children and adolescents have obesity. Beyond the Data - Preventing Childhood Obesity: Eating Better, Moving More Centers for ...