NCT04154319

Brief Summary

The overall goal of this study to promote HPV vaccine uptake among daughters of Latina immigrants between the ages of 9 and 12.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

4.2 years

First QC Date

November 4, 2019

Last Update Submit

November 4, 2019

Conditions

Cervical CancerHealthy Diet

Keywords

HPV vaccinationHealthy EatingLatina immigrants

Outcome Measures

Primary Outcomes (3)

  • HPV vaccination among 9-12yo daughters of Latina immigrants

    Daughters of mothers assigned to the HPV vaccination arm will more likely to complete the recommended HPV doses at 7-month follow-up than daughters of mothers assigned to the healthy eating arm.

    7 months

  • Healthy eating among Latina immigrants and their 9-12 yo daughters

    Mothers and daughters assigned to the healthy eating arm will be more likely to eat fried food less than once per week, consume at least three portions of fruit/vegetables per day and have less than one sweetened beverage per day at 7-months than mothers and daughters assigned to the HPV vaccination arm

    7 months

  • Appropriate nutrition label interpretation among Latina immigrants mothers and 9-'12yo daughters

    Mothers and daughters assigned to the healthy eating arm will be more likely to read nutrition labels sometimes/always and correctly interpret nutrition labels than mothers and daughters assigned to the HPV vaccination arm

    7 months

Study Arms (2)

HPV Vaccination

ACTIVE COMPARATOR

Mothers participated in educational/behavior change sessions to promote HPV vaccination among their 9-12 year old daughters

Behavioral: HPV VaccinationBehavioral: Healthy Eating

Healthy Eating

ACTIVE COMPARATOR

Mothers and daughters participated in educational/behavior change sessions to promote healthy eating and appropriate nutrition label interpretation

Behavioral: Healthy Eating

Interventions

HPV VaccinationBEHAVIORAL

Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters

HPV Vaccination
Healthy EatingBEHAVIORAL

Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels

HPV VaccinationHealthy Eating

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Latina immigrant
  • Resident of selected randomization unit (place of residence)
  • years of age and older
  • At least one HPV unvaccinated daughter between the ages of 9 and 12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Scarinci IC, Hansen B, Kim YI. A Cluster-Randomized Controlled Trial to Evaluate a Community-Based Healthy Eating and Nutrition Label Interpretation Intervention Among Latinx Immigrant Mothers and Their Daughters. J Community Health. 2021 Apr;46(2):313-323. doi: 10.1007/s10900-020-00885-x.

    PMID: 32671515DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

June 15, 2012

Primary Completion

August 10, 2016

Study Completion

August 10, 2016

Last Updated

November 6, 2019

Record last verified: 2019-11