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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Bronx-Lebanon Hospital Center Health Care System
Sponsor:
Collaborator:
UnitedHealthcare Foundation
Information provided by (Responsible Party):
Mamta Reddy, MD, Bronx-Lebanon Hospital Center Health Care System
ClinicalTrials.gov Identifier:
NCT01649115
First received: July 18, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Childhood Obesity
 Other: Healthy Lifestyles Passport

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Further study details as provided by Bronx-Lebanon Hospital Center Health Care System:

Primary Outcome Measures:
  • Change in child's gender-specific weight-for-length (WFL) z-score [ Time Frame: 4-months to 6-months of the child's age ] [ Designated as safety issue: No ]
    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:
  • Child's Body Mass Index (BMI) [ Time Frame: At 2-years and 5-years of the child's age. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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:
  • Change in child's gender-specific weight-for-length (WFL) z-score [ Time Frame: 0-months to 2-months of the child's age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649115

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

No publications provided

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
Study First Received: July 18, 2012
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bronx-Lebanon Hospital Center Health Care System:
obesity
childhood obesity
overweight
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
Body Weight
Nutrition Disorders
 Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015