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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Other: Healthy Lifestyles Passport	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Prevention
Official Title:	The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)
Study Start Date :	August 2012
Estimated Primary Completion Date :	August 2013
Estimated Study Completion Date :	August 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Change in child's gender-specific weight-for-length (WFL) z-score [ Time Frame: 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 :

1. Child's Body Mass Index (BMI) [ Time Frame: 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.
2. Mother's Knowledge, Skill, Attitude and Behavior. [ Time Frame: 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.

Other Outcome Measures:

1. Change in child's gender-specific weight-for-length (WFL) z-score [ Time Frame: 0-months to 2-months of the child's age ]
   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.
2. Change in child's gender-specific weight-for-length (WFL) z-score [ Time Frame: 2-months to 4-months of the child's age ]
   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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Tara N Scheiner, MS, RD	718-960-1416	Tschein@bronxleb.org

Locations

United States, New York
Bronx-Lebanon Hospital Center	Not yet recruiting
Bronx, New York, United States, 10457

Sponsors and Collaborators

Bronx-Lebanon Hospital Center Health Care System

UnitedHealthcare Foundation

Investigators

Principal Investigator:	Mamta Reddy, MD	Bronx-Lebanon Hospital Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mamta Reddy, MD, Director, Pediatric Asthma Center; Chief, Allergy/Immunology, Bronx-Lebanon Hospital Center Health Care System
ClinicalTrials.gov Identifier:	NCT01649115 History of Changes
Other Study ID Numbers:	HLPP 2012
First Posted:	July 25, 2012
Last Update Posted:	August 9, 2012
Last Verified:	August 2012

Keywords provided by Mamta Reddy, MD, Bronx-Lebanon Hospital Center Health Care System:

obesity; overweight; childhood obesity; prevention; Z score; weight for length; WFL; body mass index; BMI; prenatal	maternal; nutrition education; health education; health literacy; health numeracy; passport; healthy lifestyles; growth; growth chart

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms