The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity (HLPP)
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ClinicalTrials.gov Identifier: NCT01649115 |
Recruitment Status
: Unknown
Verified August 2012 by Mamta Reddy, MD, Bronx-Lebanon Hospital Center Health Care System.
Recruitment status was: Not yet recruiting
First Posted
: July 25, 2012
Last Update Posted
: August 9, 2012
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Condition or disease | Intervention/treatment | Phase |
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Childhood Obesity | Other: Healthy Lifestyles Passport | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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- 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.
- 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.
- 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.
- 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.
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649115
Contact: Tara N Scheiner, MS, RD | 718-960-1416 | Tschein@bronxleb.org |
United States, New York | |
Bronx-Lebanon Hospital Center | Not yet recruiting |
Bronx, New York, United States, 10457 |
Principal Investigator: | Mamta Reddy, MD | Bronx-Lebanon Hospital Center |
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 Key Record Dates |
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 |