An interventional study of behavioral counseling and Education Materials in Pediatric Obesity, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 518 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
A child is eligible for the POM trial for meeting the following criteria:
Exclusion Criteria:
A child will be excluded if he/she has:
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 · Other: Education Materials · Behavioral: Text messages
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 · Other: Education Materials · Behavioral: Face to face counseling session · Behavioral: Text messages · Behavioral: Telephone Counseling · Behavioral: Newsletters
Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
Health education materials about healthy eating and physical activity and a community resource guide
30 minute face-to-face family-centered behavioral counseling session delivered by a health educator
regularly scheduled cell phone text messages for 12 months
Also known as: SMS
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
12 monthly newsletters mailed to participant homes
Change from baseline in weight (kg)
Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.
Time frame: 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
Time frame: 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.
Time frame: 6 months
Change from baseline in fasting insulin (µIu/mL)
Fasting samples of serum will be drawn by a phlebotomist and processed by a commercial laboratory.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Change from baseline in moderate-to-vigorous physical activity (minutes/week)
Minutes per week of MVPA is assessed using accelerometry.
Time frame: 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).
Time frame: 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).
Time frame: 6 months
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center at San Antonio