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

Childhood Obesity Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01649115
• Other study ID #: HLPP 2012
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2012
• Last updated: August 8, 2012
• Start date: August 2012
• Est. completion date: August 2017

Study information

• Verified date: August 2012
• Source: Bronx-Lebanon Hospital Center Health Care System
• Contact: Tara N Scheiner, MS, RD
• Phone: 718-960-1416
• Email: Tschein[@]bronxleb.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2017
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Bronx-Lebanon Hospital Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bronx-Lebanon Hospital Center Health Care System	UnitedHealthcare Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 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.	0-months to 2-months of the child's age	No
Other	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 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	2-months to 4-months of the child's age	No
Primary	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	No
Secondary	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.	At 2-years and 5-years of the child's age.	No
Secondary	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.	Baseline, day after the intervention and two months after the baby is born.	No