The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity
HLPP
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 25, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 9, 2012
August 1, 2012
1 year
July 18, 2012
August 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Child's Body Mass Index (BMI)
At 2-years and 5-years of the child's age.
Mother's Knowledge, Skill, Attitude and Behavior.
Baseline, day after the intervention and two months after the baby is born.
Other Outcomes (2)
Change in child's gender-specific weight-for-length (WFL) z-score
0-months to 2-months of the child's age
Change in child's gender-specific weight-for-length (WFL) z-score
2-months to 4-months of the child's age
Study Arms (2)
Usual Care
NO INTERVENTIONThe 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.
Healthy Lifestyles Passport
EXPERIMENTALThe 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.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mamta Reddy, MD
Bronx-Lebanon Hospital Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Pediatric Asthma Center; Chief, Allergy/Immunology
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 25, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2017
Last Updated
August 9, 2012
Record last verified: 2012-08