Health4Kids Intervention Trial for Hispanic Families

NCT02343367 | Completed

• 2 other identifiers: HSC20130465HR01HD075936
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pediatric Obesity

Keywords

Hispanic; overweight; families; pediatric; primary care

Outcome Measures

Primary Outcomes (3)

• Change from baseline in weight (kg)

  Weight will be measured using a portable Tanita Body Composition Analyzer SC-331S following standard protocol.

  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

  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.

  6 months

Secondary Outcomes (6)

• Change from baseline in fasting insulin (µIu/mL)

  6 months

• Change from baseline in fasting glucose (mg/dL)

  6 months

• Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)

  6 months

• Change from baseline in moderate-to-vigorous physical activity (minutes/week)

  6 months

• Change from baseline in consumption of sugar-sweetened beverages (servings/week)

  6 months

Study Arms (2)

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

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.

Behavioral: behavioral counseling; Other: Education Materials; Behavioral: Face to face counseling session; Behavioral: Text messages; Behavioral: Telephone Counseling; Behavioral: Newsletters

Interventions

behavioral counseling BEHAVIORAL

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

Pediatric Obesity Management; Standard Care

Education Materials OTHER

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

Pediatric Obesity Management; Standard Care

Face to face counseling session BEHAVIORAL

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

Pediatric Obesity Management

Text messages BEHAVIORAL

regularly scheduled cell phone text messages for 12 months

Also known as: SMS

Pediatric Obesity Management; Standard Care

Telephone Counseling 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

Pediatric Obesity Management

Newsletters BEHAVIORAL

12 monthly newsletters mailed to participant homes

Pediatric Obesity Management

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• The University of Texas at San Antonio: collaborator
• Bexar County Hospital District DBA University Health System: collaborator

Study Sites (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Overweight

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deborah M Parra-Medina, PhD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: November 19, 2019
• Study Completion: March 31, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (1)