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

Study Overview
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Brief Summary
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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.

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

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Helping HAND (Healthy Nutrition and Activity Directions)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: wait-list control arm<br>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)<br>* 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.<br>|
| Experimental: Intervention arm<br>see intervention description | Behavioral: Helping HAND (Healthy Nutrition and Activity Directions)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, primary care, treatment, parenting, lifestyle behaviors