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

B

Bronx-Lebanon Hospital Center Health Care System

Status

Unknown

Conditions

Childhood Obesity

Treatments

Other: Healthy Lifestyles Passport

Study type

Interventional

Funder types

Other

Identifiers

NCT01649115
HLPP 2012

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Usual Care
No Intervention group
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.
Healthy Lifestyles Passport
Experimental group
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.
Treatment:
Other: Healthy Lifestyles Passport

Trial contacts and locations

1

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Central trial contact

Tara N Scheiner, MS, RD

Data sourced from clinicaltrials.gov

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