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Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND

NCT01195012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-09

No results posted yet for this study

Summary

This is a feasibility study to evaluate a 6-month obesity treatment intervention (Helping HAND: Health Activity and Nutrition Directions) for pediatric primary care clinics. The program targets 5-8 year old children and their parents to change the child's lifestyle behaviors and the associated parenting practices to improve the child's weight status. Four community clinics participated. Families were recruited from clinics and after informed consent and baseline data have been obtained, the families were randomized into one of two groups: (1) the treatment group who immediately participated in Helping HAND or (2) the wait list control group, who started the program 7 months later. Data were gathered on all the participating children and their parents at three time points: baseline, post the intervention (month 7) and post the wait list control group completing the intervention (month 14).

This was a pilot study to test the feasibility of an obesity prevention plus program delivered in the child's primary care clinic. The primary outcome was family attendance to the 3 data-collection meetings with research staff and the 6 prevention plus intervention sessions with a trained Health Advisor.

Conditions

  • Childhood Obesity

Interventions

BEHAVIORAL

Helping HAND (Healthy Nutrition and Activity Directions)

6-month behavioral intervention targeting 5-8 year old children and their parents to improve the child's lifestyle behaviors to improve their weight status. The families met monthly with trained Health Advisors for individual sessions in the pediatric clinic with phone calls in between visits to check on progress.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195012 on ClinicalTrials.gov