The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity

Not Applicable

• Conditions: Childhood Obesity
• Interventions: Other: Healthy Lifestyles Passport

• Registration Number: NCT01649115
• Lead Sponsor: Bronx-Lebanon Hospital Center Health Care System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-25
• Status Verified: 2012-08
• Study Start: 2012-08
• Last Update Submitted: 2012-08-08
• Last Update Posted: 2012-08-09
• Primary Completion: 2013-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• pregnant women during the third trimester (>28 weeks gestation) receiving care in the institution's Women's Health Center
• no medical conditions complicating their pregnancy
• must be able to communicate in English or Spanish
• be reachable by phone
• plan to be the consistent caretaker of the child at least 75% of the time
• plan to attend the institution's pediatric outpatient clinic for the child's routine healthcare

Exclusion Criteria

• Child with any disabling or chronic illnesses
• Any existing and/or pre-existing disabling or chronic illnesses that would qualify the mother as "high risk"
• Wards of the state
• Mothers with a disabling/serious chronic illness
• Drug/alcohol use during pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Lifestyles Passport	Healthy Lifestyles Passport	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.

Primary Outcome Measures

Name	Time	Method
Change in child's gender-specific weight-for-length (WFL) z-score	4-months to 6-months of the child's age	The child's weight and length will be extracted from the medical record at the child's 4-month and 6-month old office visit and the weight-for-length z-scores will be calculated. The difference between each arm's z-score will be compared.

Secondary Outcome Measures

Name	Time	Method
Child's Body Mass Index (BMI)	At 2-years and 5-years of the child's age.	At 2-years and 5-years of age, the child's height and weight will be extracted from the medical record and BMI will be calculated. Each arm's BMI z-score will then be compared.
Mother's Knowledge, Skill, Attitude and Behavior.	Baseline, day after the intervention and two months after the baby is born.	At baseline, all participants will answer a battery of questionnaires, including a pre-test and the "Newest Vital Sign" assessment tool. The day after the intervention, a post-test will be administered over the phone to the participants in both arms. Two months after the baby is born the same post-test and the "Newest Vital Sign" assessment tool will be administered in person.

Trial Locations

Locations (1)

Bronx-Lebanon Hospital Center; 🇺🇸 Bronx, New York, United States