Childhood ObesityHLPPNCT01649115
The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity
A study testing Healthy Lifestyles Passport in people with Childhood Obesity, run by Bronx-Lebanon Hospital Center Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Lifestyles Passport
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
About this study
Official title: The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)
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.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Lifestyles Passport
- 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
- Medical subject headings
- Pediatric Obesity, Obesity, Overweight, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyles PassportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 | 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. Receives: Other: Healthy Lifestyles Passport |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: At 2-years and 5-years of the child's age.
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.
Measured: Baseline, day after the intervention and two months after the baby is born.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bronx-Lebanon Hospital Center Health Care System
- Sponsor type
- University, hospital or other
- Collaborators
- UnitedHealthcare Foundation
- Responsible party
- Principal investigator, Mamta Reddy, MD, Bronx-Lebanon Hospital Center Health Care System
- Investigators
- Mamta Reddy, MD, Principal investigator, Bronx-Lebanon Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649115
- Sponsor's protocol ID
- HLPP 2012
- Acronym
- HLPP
- Status last verified
- Aug 2012
- First submitted
- 18 Jul 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Lifestyles Passport Program: a Randomized Control Trial of a Prenatal Maternal Education Program to Prevent Infant and Childhood Obesity (HLPP)
- ClinicalTrials.gov ID
- NCT01649115
- Acronym / sponsor ID
- HLPP / HLPP 2012
- Conditions
- Childhood Obesity
- Keywords
- obesity, overweight, childhood obesity, prevention, Z score, weight for length, WFL, body mass index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bronx-Lebanon Hospital Center Health Care SystemUniversity, hospital or other
- Collaborators
- UnitedHealthcare Foundation
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 | Other: Healthy Lifestyles PassportThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Lifestyles PassportThe 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. | Other | Healthy Lifestyles Passport |
Primary outcome
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.
2 secondary outcomes
Child's Body Mass Index (BMI)
Time frame: At 2-years and 5-years of the child's age.
Mother's Knowledge, Skill, Attitude and Behavior.
Time frame: Baseline, day after the intervention and two months after the baby is born.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamta Reddy, MD principal investigator
Bronx-Lebanon Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyles Passport in people with Childhood Obesity, run by Bronx-Lebanon Hospital Center Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tara N Scheiner, MS, RD (718-960-1416, Tschein@bronxleb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child's gender-specific weight-for-length (WFL) z-score (time frame: 4-months to 6-months of the child's age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.