Status:
COMPLETED
Pilot RCT of an Obesity Intervention for Primary Care Pediatrics: Helping HAND
Lead Sponsor:
Baylor College of Medicine
Conditions:
Childhood Obesity
Eligibility:
All Genders
5-8 years
Phase:
NA
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 ye...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01195012
Start Date
June 1 2008
End Date
July 1 2010
Last Update
March 9 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030