MedDataX Logo

Health4Kids Intervention Trial for Hispanic Families

NCT ID: NCT02343367

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The H4K Trial is a randomized controlled trial to improve children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the H4K intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The investigators hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Given the continuing rise of the U.S. Hispanic population, reversing the Hispanic childhood obesity epidemic is critical to the nation's future health. Mexican American children and those from socioeconomically disadvantaged families often are far more overweight and obese than their peers, heightening their risk for obesity-related health complications. Our proposed randomized controlled trial, the Health4Kids (H4K) Trial for Hispanic Families, aims to improve Hispanic children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese (body mass index (BMI) between the 85th and 99.9thth (\<99th) percentile for age and gender) Hispanic children ages 6-11 in pediatric clinics in San Antonio, Texas, a largely Hispanic city. Our team, formed during our pilot research funded by the Centers for Medicare and Medicaid Services (1H0CMS030457), unites academic investigators and community partners with experience working together to conduct behavioral and clinical interventions and outreach with Hispanics. The H4K trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. We will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the POM intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). From a baseline, we will measure the impact of the trial on the primary outcome (body composition) and secondary outcomes (insulin, glucose and cholesterol levels and several specific health behavior changes) at 1 month, 6 and 12 months post-randomization. We also will evaluate the critical role of parenting strategies and changes in the home environment as mediators of intervention effects. We hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Obesity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hispanic overweight families pediatric primary care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Care

Brief patient-centered behavioral counseling using the Healthy Lifestyle Prescription, health education materials and a community resource guide. Follow-up visits scheduled at 1, 6, and 12 months. Parent receives weekly general health education cell phone text messages for 12 months

Group Type ACTIVE_COMPARATOR

behavioral counseling

Intervention Type BEHAVIORAL

Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription

Education Materials

Intervention Type OTHER

Health education materials about healthy eating and physical activity and a community resource guide

Text messages

Intervention Type BEHAVIORAL

regularly scheduled cell phone text messages for 12 months

Pediatric Obesity Management

All elements of standard care plus a family-based face to face counseling session with a health educator, telephone counseling, mailed newsletters and regularly scheduled cell phone text messages with tips and motivational messages for healthy eating and PA, as well as information on community events and resources.

Group Type EXPERIMENTAL

behavioral counseling

Intervention Type BEHAVIORAL

Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription

Education Materials

Intervention Type OTHER

Health education materials about healthy eating and physical activity and a community resource guide

Face to face counseling session

Intervention Type BEHAVIORAL

30 minute face-to-face family-centered behavioral counseling session delivered by a health educator

Text messages

Intervention Type BEHAVIORAL

regularly scheduled cell phone text messages for 12 months

Telephone Counseling

Intervention Type BEHAVIORAL

14 telephone counseling sessions delivered by a health educator using motivational interviewing techniques. Two sessions per month for the first two months followed by one session per month for 10 months

Newsletters

Intervention Type BEHAVIORAL

12 monthly newsletters mailed to participant homes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

behavioral counseling

Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription

Intervention Type BEHAVIORAL

Education Materials

Health education materials about healthy eating and physical activity and a community resource guide

Intervention Type OTHER

Face to face counseling session

30 minute face-to-face family-centered behavioral counseling session delivered by a health educator

Intervention Type BEHAVIORAL

Text messages

regularly scheduled cell phone text messages for 12 months

Intervention Type BEHAVIORAL

Telephone Counseling

14 telephone counseling sessions delivered by a health educator using motivational interviewing techniques. Two sessions per month for the first two months followed by one session per month for 10 months

Intervention Type BEHAVIORAL

Newsletters

12 monthly newsletters mailed to participant homes

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SMS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A child is eligible for the POM trial for meeting the following criteria:

* identified by parent or legal guardian as Hispanic
* age 6-11
* overweight or obese (BMI between the 85th and 99.9thth (\<99th) percentile for age and gender
* one parent/guardian that the child resides with full-time must agree to participate in intervention and evaluation activities.

Exclusion Criteria

* A child will be excluded if he/she has:

* a mental, emotional, or physical handicap identified by parents or health care provider that may interfere with study participation
* a diagnosis of cardiovascular, pulmonary, or digestive disease
* parent without a cell phone
* parent unable or not willing to receive text messages
* child or parent planning to move from the local area within the time span of the study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

The University of Texas at San Antonio

OTHER

Sponsor Role collaborator

Bexar County Hospital District DBA University Health System

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah M Parra-Medina, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health San Antonio

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HD075936

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20130465H

Identifier Type: -

Identifier Source: org_study_id