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

March 5, 2020 updated by: Teresia O'Connor, Baylor College of Medicine

Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor college of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Child: Healthy 5 to 8 year old child who is overweight (BMI =/>85%), but not morbidly obese (BMI<99%)
  • 2) Child attends one of 4 TCPA clinics
  • 3) Child is Texas Children's Health Plan member/participant
  • 4) Parent who is child's primary care taker able and willing to participate
  • 5) Parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months
  • 6) Only one child per family will be eligible to participate.

Exclusion Criteria:

  • 1) Parent unable to read or write in English or Spanish.
  • 2) Parent or child unable to participate in counseling sessions in English or Spanish
  • 3) Child with BMI =/> 99%tile
  • 4) Child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention.
  • 5) Child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status
  • 6) Child with medical problems that could influence their diet or physical activity or make it difficult for that child to participate in a behavior change program (such as mental retardation, neurologic disorders, severe food allergies or severe cardiac or pulmonary disease that restricts their activities).
  • 7) Parents who participated in interviews during the developmental phase of Helping HAND
  • 8) Family currently participating in other weight treatment of prevention programs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: wait-list control arm
Participants wait-listed to start the behavioral obesity treatment program (Helping HAND) after time two data collection (7 months after baseline).
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.
EXPERIMENTAL: Intervention arm
see intervention description
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (ESTIMATE)

September 3, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM-H-22657

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on Helping HAND (Healthy Nutrition and Activity Directions)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe