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

The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity
• Intervention / Treatment: Other: Healthy Lifestyles Passport

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara N Scheiner, MS, RD; Phone Number: 718-960-1416; Email: Tschein@bronxleb.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10457
      • Bronx-Lebanon Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Experimental: 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.	Other: Healthy Lifestyles Passport; The participants will be provided with the Healthy Lifestyles Passport, and with each corresponding page, there will be an activity. Each participant in the Healthy Lifestyles Passport arm will receive the same education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child's gender-specific weight-for-length (WFL) z-score	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.	4-months to 6-months of the child's age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's Body Mass Index (BMI)	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.	At 2-years and 5-years of the child's age.
Mother's Knowledge, Skill, Attitude and Behavior.	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.	Baseline, day after the intervention and two months after the baby is born.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child's gender-specific weight-for-length (WFL) z-score	The child's weight and length will be extracted from the medical record at the child's 0-month and 2-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.	0-months to 2-months of the child's age
Change in child's gender-specific weight-for-length (WFL) z-score	The child's weight and length will be extracted from the medical record at the child's 2-month and 4-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	2-months to 4-months of the child's age

Collaborators and Investigators

• Sponsor: Bronx-Lebanon Hospital Center Health Care System
• Collaborators: UnitedHealthcare Foundation
• Investigators: Principal Investigator: Mamta Reddy, MD, Bronx-Lebanon Hospital Center

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): August 9, 2012
• Last Update Submitted That Met QC Criteria: August 8, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: body mass index; obesity; overweight; childhood obesity; growth; prevention; health literacy; prenatal; nutrition education; BMI; health education; Z score; health numeracy; maternal; growth chart; weight for length; WFL; passport; healthy lifestyles
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HLPP 2012