Intervention for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Penn State Milton S. Hershey Medical Center, Hershey, PAObesityIntervention - Behavioral
Eligibility
1 - 1
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether mothers who are overweight can better match their baby's formula feedings to their needs, promoting optimal growth in the first 6 months.

Eligible Conditions
  • Overweight and Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: Spanning ages 1-6 months

Month 6
Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards
Month 6
Proportion of Infants with Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)
Month 6
Conditional Weight Gain Difference Between Study Groups
Spanning ages 1-6 months
Growth Trajectory (repeated measures of weight-for-length on World Health Organization Child growth standards) during the intervention period

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Intervention · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73850

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: spanning ages 1-6 months

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,421 Previous Clinical Trials
6,749,106 Total Patients Enrolled
1 Trials studying Overweight and Obesity
32 Patients Enrolled for Overweight and Obesity
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,840 Previous Clinical Trials
2,162,762 Total Patients Enrolled
6 Trials studying Overweight and Obesity
14,294 Patients Enrolled for Overweight and Obesity
Milton S. Hershey Medical CenterLead Sponsor
466 Previous Clinical Trials
2,785,774 Total Patients Enrolled
1 Trials studying Overweight and Obesity
8 Patients Enrolled for Overweight and Obesity
Ian Paul, MD, MScPrincipal InvestigatorPenn State College of Medicine
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 1 - 1 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

How many participants has this trial recruited thus far?

"Affirmative. As evidenced by clinicaltrials.gov, the research initiative initially posted on January 20th 2022 is presently recruiting participants at one site and needs around 60 volunteers to join." - Anonymous Online Contributor

Unverified Answer

Might I qualify to participate in this experimental research?

"This clinical trial is seeking 60 neonates between the age of 24 hours and 4 weeks that are already overweight. Potential subjects must also possess no substantial birth complications (e.g chromosomal defects, metabolic issues, cleft lip/palate etc.), be born at a Division of Academic General Pediatrics practice site (Hope Drive, Elizabethtown or Nyes Road), weigh more than 50th percentile according to 2013 Fenton Growth Charts for sex and gestational age at birth, have been delivered full-term (>37 weeks) as singleton infants and their mothers need to be over 18 years old in order to participate in this research project." - Anonymous Online Contributor

Unverified Answer

Is this research study still taking on new participants?

"Confirmed. Per the information on clinicaltrials.gov, this research project is currently recruiting volunteers and has been since January 20th 2021 (most recently updated July 21st 2022). 60 participants are required from a single hospital location." - Anonymous Online Contributor

Unverified Answer

Is the age eligibility for this medical research restricted to adults aged 45 and under?

"To be included in this trial, infants who are between 1 day and 1 month old must enroll. Additionally, 54 studies cater to children under 18 years of age while 206 trials focus on those 65 or older." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.