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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2012 by Mamta Reddy, MD, Bronx-Lebanon Hospital Center Health Care System.
Recruitment status was: Not yet recruiting

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 (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)

Resource links provided by NLM:

MedlinePlus related topics: Healthy Living

U.S. FDA Resources

Further study details as provided by Mamta Reddy, MD, 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 ]
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. ]
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.

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 ]
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


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.

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


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

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


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

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

ClinicalTrials.gov processed this record on September 20, 2017

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