← Back to Search

Healthy Lifestyles Passport for Childhood Obesity (HLPP Trial)

N/A

Waitlist Available

Led By Mamta Reddy, MD

Research Sponsored by Bronx-Lebanon Hospital Center Health Care System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2-years and 5-years of the child's age.

Awards & highlights

No Placebo-Only Group

Summary

The purpose of this study is to evaluate the effectiveness of the Healthy Lifestyles Passport Program (HLPP) in preventing infant and childhood obesity. It is hypothesized that the participants in the intervention arm will exhibit less excessive weight-for-length gain from 4- to 6-months of age. In 2-years and 5-years, it is predicted that the participants in the intervention arm will yield lower Body Mass Index (BMI) z-scores than the participants in the control arm, who receive usual care.

Eligible Conditions

Childhood Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2-years and 5-years of the child's age.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2-years and 5-years of the child's age.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2-years and 5-years of the child's age. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Child's Body Mass Index (BMI)

Mother's Knowledge, Skill, Attitude and Behavior.

Other study objectives

Change in child's gender-specific weight-for-length (WFL) z-score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Lifestyles PassportExperimental Treatment1 Intervention

The Healthy Lifestyles Passport arm will be receiving the intervention. They will be meeting with the Registered Dietitian twice in person after the participants are randomized into each arm, and once on the phone. The first meeting, they will be receiving the Healthy Lifestyles Passport, including the interactive nutrition education. The second meeting is a post-test assessment and Newest Vital Sign Assessment Tool.

Group II: Usual CareActive Control1 Intervention

The Usual Care arm, will not be receiving the interactive nutrition education. They will be meeting with the Registered Dietitian twice in person after the participants are randomized in each arm, and once on the phone. The first meeting, they will be receiving pamphlets and handouts, which are typically given as part of usual care. The second meeting is a post-test assessment and Newest Vital Sign Assessment Tool. The second meeting and the follow-up phone call are both the same for usual care and the Healthy Lifestyles Passport arm.

Do I qualify?Apply below to find out