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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helping HAND (Healthy Nutrition and Activity Directions)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Childhood Obesity focused on measuring child, primary care, treatment, parenting, lifestyle behaviors

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

wait-list control arm

Intervention arm

Arm Description

Participants wait-listed to start the behavioral obesity treatment program (Helping HAND) after time two data collection (7 months after baseline).

see intervention description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 2, 2010
Last Updated
March 5, 2020
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01195012
Brief Title
Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND
Acronym
Helping HAND
Official Title
Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
child, primary care, treatment, parenting, lifestyle behaviors

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wait-list control arm
Arm Type
Other
Arm Description
Participants wait-listed to start the behavioral obesity treatment program (Helping HAND) after time two data collection (7 months after baseline).
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
see intervention description
Intervention Type
Behavioral
Intervention Name(s)
Helping HAND (Healthy Nutrition and Activity Directions)
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22066521
Citation
O'Connor TM, Hilmers A, Watson K, Baranowski T, Giardino AP. Feasibility of an obesity intervention for paediatric primary care targeting parenting and children: Helping HAND. Child Care Health Dev. 2013 Jan;39(1):141-9. doi: 10.1111/j.1365-2214.2011.01344.x. Epub 2011 Nov 9.
Results Reference
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Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND

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