Pediatric ObesityH4KNCT02343367
Health4Kids Intervention Trial for Hispanic Families
A study testing behavioral counseling, Education Materials and Face to face counseling session in people with Pediatric Obesity, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- behavioral counseling, Education Materials and Face to face counseling session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 31 Mar 2020
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: Pediatric Obesity Management Intervention Trial for Hispanic Families
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- behavioral counseling, Education Materials, Face to face counseling session, Text messages, Telephone Counseling
- Keywords
- Hispanic, overweight, families, pediatric, primary care
- Medical subject headings
- Pediatric Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral counselingBehavioural
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Education MaterialsOther
Health education materials about healthy eating and physical activity and a community resource guide
Face to face counseling sessionBehavioural
30 minute face-to-face family-centered behavioral counseling session delivered by a health educator
Text messagesBehavioural
Also called SMS
regularly scheduled cell phone text messages for 12 months
Telephone CounselingBehavioural
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
NewslettersBehavioural
12 monthly newsletters mailed to participant homes
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | 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 Receives: Behavioral: behavioral counseling; Other: Education Materials; Behavioral: Text messages |
| Pediatric Obesity Management | Experimental | 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. Receives: Behavioral: behavioral counseling; Other: Education Materials; Behavioral: Face to face counseling session; Behavioral: Text messages; Behavioral: Telephone Counseling; Behavioral: Newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight (kg)
Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.
Measured: 6 months
Change from baseline in waist circumference (cm)
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
Measured: 6 months
Change from baseline in body mass index (BMI z score)
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.
Measured: 6 months
Secondary outcomes (6)
Change from baseline in fasting insulin (µIu/mL)
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
Measured: 6 months
Change from baseline in fasting glucose (mg/dL)
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
Measured: 6 months
Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
Measured: 6 months
Change from baseline in moderate-to-vigorous physical activity (minutes/week)
Minutes per week of MVPA is assessed using accelerometry.
Measured: 6 months
Change from baseline in consumption of sugar-sweetened beverages (servings/week)
Sugar-sweetened beverage consumption is assessed using the Block Kids Food Screener (Last Week version).
Measured: 6 months
Change from baseline in consumption of fruits and vegetables (servings/day)
Fruit and vegetable consumption is assessed using the Block Kids Food Screener (Last Week version).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion19 Nov 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The University of Texas at San Antonio, Bexar County Hospital District dba University Health
- Responsible party
- Sponsor
- Investigators
- Deborah M Parra-Medina, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343367
- Sponsor's protocol ID
- HSC20130465H
- Other IDs
- R01HD075936
- Acronym
- H4K
- Status last verified
- Dec 2020
- First submitted
- 6 Jan 2015
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Obesity Management Intervention Trial for Hispanic Families
- ClinicalTrials.gov ID
- NCT02343367
- Acronym / sponsor ID
- H4K / HSC20130465H
- Conditions
- Pediatric Obesity
- Keywords
- Hispanic, overweight, families, pediatric, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The University of Texas at San Antonio, Bexar County Hospital District dba University Health
- Study start
- Jan 2015
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Jan 2015 (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 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: behavioral counseling, Other: Education Materials, Behavioral: Text messagesBrief 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 |
| Pediatric Obesity Management | Experimental | Behavioral: behavioral counseling, Other: Education Materials, Behavioral: Face to face counseling session, Behavioral: Text messages, Behavioral: Telephone Counseling, Behavioral: NewslettersAll 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A child is eligible for the POM trial for meeting the following criteria:
Key exclusion criteria (6 listed)
- A child will be excluded if he/she has:
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 |
|---|---|---|
| behavioral counselingPediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription | Behavioural | Pediatric Obesity Management, Standard Care |
| Education MaterialsHealth education materials about healthy eating and physical activity and a community resource guide | Other | Pediatric Obesity Management, Standard Care |
| Face to face counseling session30 minute face-to-face family-centered behavioral counseling session delivered by a health educator | Behavioural | Pediatric Obesity Management |
| Text messagesAlso: SMSregularly scheduled cell phone text messages for 12 months | Behavioural | Pediatric Obesity Management, Standard Care |
| Telephone Counseling14 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 | Behavioural | Pediatric Obesity Management |
| Newsletters12 monthly newsletters mailed to participant homes | Behavioural | Pediatric Obesity Management |
Primary outcome
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.
6 secondary outcomes
Change from baseline in fasting insulin (µIu/mL)
Time frame: 6 months
Change from baseline in fasting glucose (mg/dL)
Time frame: 6 months
Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)
Time frame: 6 months
Change from baseline in moderate-to-vigorous physical activity (minutes/week)
Time frame: 6 months
Change from baseline in consumption of sugar-sweetened beverages (servings/week)
Time frame: 6 months
Change from baseline in consumption of fruits and vegetables (servings/day)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
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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.
Deborah M Parra-Medina, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral counseling, Education Materials and Face to face counseling session in people with Pediatric Obesity, run by The University of Texas Health Science Center at San Antonio 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 21 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight (kg) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 21 Dec 2020.