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Trial record 1 of 2 for:    h4k
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Health4Kids Intervention Trial for Hispanic Families (H4K)

This study is currently recruiting participants.
Verified August 2017 by The University of Texas Health Science Center at San Antonio
Sponsor:
ClinicalTrials.gov Identifier:
NCT02343367
First Posted: January 22, 2015
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas at San Antonio
Bexar County Hospital System DBA University Health Systems
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
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.

Condition Intervention
Pediatric Obesity Behavioral: behavioral counseling Other: Education Materials Behavioral: Face to face counseling session Behavioral: Text messages Behavioral: Telephone Counseling Behavioral: Newsletters

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Obesity Management Intervention Trial for Hispanic Families

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Change from baseline in weight (kg) [ Time Frame: 6 months ]
    Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.

  • Change from baseline in waist circumference (cm) [ Time Frame: 6 months ]
    Waist circumference (minimum waist girth) will be measured to the nearest 0.1 cm using a Myotape tape measure at the midpoint between the right iliac crests and the lower ribs when the subject is standing erect with feet together

  • Change from baseline in body mass index (BMI z score) [ Time Frame: 6 months ]
    BMI will be calculated as weight (kg)/height squared (m2). Weight will be measured by bioelectrical impedance analysis (BIA) using the foot-to-foot pressure contact electrode BIA technique using a portable Tanita Body Composition Analyzer SC-331S following standard protocol. Height will be measured to the nearest 0.1 inch using a SECA brand stadiometer.


Secondary Outcome Measures:
  • Change from baseline in fasting insulin (µIu/mL) [ Time Frame: 6 months ]
    Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.

  • Change from baseline in fasting glucose (mg/dL) [ Time Frame: 6 months ]
    Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.

  • Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL) [ Time Frame: 6 months ]
    Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.

  • Change from baseline in moderate-to-vigorous physical activity (minutes/week) [ Time Frame: 6 months ]
    Minutes per week of MVPA is assessed using accelerometry.

  • Change from baseline in consumption of sugar-sweetened beverages (servings/week) [ Time Frame: 6 months ]
    Sugar-sweetened beverage consumption is assessed using the Block Kids Food Screener (Last Week version).

  • Change from baseline in consumption of fruits and vegetables (servings/day) [ Time Frame: 6 months ]
    Fruit and vegetable consumption is assessed using the Block Kids Food Screener (Last Week version).


Estimated Enrollment: 460
Study Start Date: January 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Behavioral: behavioral counseling
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Other: Education Materials
Health education materials about healthy eating and physical activity and a community resource guide
Behavioral: Text messages
regularly scheduled cell phone text messages for 12 months
Other Name: SMS
Experimental: 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.
Behavioral: behavioral counseling
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Other: Education Materials
Health education materials about healthy eating and physical activity and a community resource guide
Behavioral: Face to face counseling session
30 minute face-to-face family-centered behavioral counseling session delivered by a health educator
Behavioral: Text messages
regularly scheduled cell phone text messages for 12 months
Other Name: SMS
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
Behavioral: Newsletters
12 monthly newsletters mailed to participant homes

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343367


Locations
United States, Texas
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Laura Esparza, MS    210-562-6514    EsparzaL@uthscsa.edu   
Contact: Dorothy Long Parma, MD, MPH    210-562-6524    LongParma@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas at San Antonio
Bexar County Hospital System DBA University Health Systems
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02343367     History of Changes
Other Study ID Numbers: R01HD075936 ( U.S. NIH Grant/Contract )
HSC20130465H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Submitted: January 6, 2015
First Posted: January 22, 2015
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by The University of Texas Health Science Center at San Antonio:
Hispanic
overweight
families
pediatric
primary care

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms