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

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyles Passport
Sponsored by
Bronx-Lebanon Hospital Center Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bronx-Lebanon Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Healthy Lifestyles Passport

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 18, 2012
Last Updated
August 8, 2012
Sponsor
Bronx-Lebanon Hospital Center Health Care System
Collaborators
UnitedHealthcare Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01649115
Brief Title
The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity
Acronym
HLPP
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx-Lebanon Hospital Center Health Care System
Collaborators
UnitedHealthcare Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Healthy Lifestyles Passport
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Lifestyles Passport
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child's gender-specific weight-for-length (WFL) z-score
Description
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.
Time Frame
4-months to 6-months of the child's age
Secondary Outcome Measure Information:
Title
Child's Body Mass Index (BMI)
Description
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.
Time Frame
At 2-years and 5-years of the child's age.
Title
Mother's Knowledge, Skill, Attitude and Behavior.
Description
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.
Time Frame
Baseline, day after the intervention and two months after the baby is born.
Other Pre-specified Outcome Measures:
Title
Change in child's gender-specific weight-for-length (WFL) z-score
Description
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.
Time Frame
0-months to 2-months of the child's age
Title
Change in child's gender-specific weight-for-length (WFL) z-score
Description
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
Time Frame
2-months to 4-months of the child's age

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara N Scheiner, MS, RD
Phone
718-960-1416
Email
Tschein@bronxleb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mamta Reddy, MD
Organizational Affiliation
Bronx-Lebanon Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx-Lebanon Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States

12. IPD Sharing Statement

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

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