Childhood Obesity Clinical Trial
— Helping HANDOfficial title:
Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND
NCT number | NCT01195012 |
Other study ID # | BCM-H-22657 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2008 |
Est. completion date | July 2010 |
Verified date | March 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 8 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
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.1365-2214.2011.0134 — View Citation
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