Pilot Randomized Controlled Trial for Feasibility of an Obesity "Prevention Plus" Intervention for Primary Care Pediatrics: Helping HAND
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 40
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
Eligibility Criteria
- Ages
- 5 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Child: Healthy 5 to 8 year old child who is overweight (BMI =/>85%), but not morbidly obese (BMI<99%)
- •Child attends one of 4 TCPA clinics
- •Child is Texas Children's Health Plan member/participant
- •Parent who is child's primary care taker able and willing to participate
- •Parent and child willing to attend and participate in 6 month intervention sessions and 3 measurement time points over 14 months
- •Only one child per family will be eligible to participate.
Exclusion Criteria
- •Parent unable to read or write in English or Spanish.
- •Parent or child unable to participate in counseling sessions in English or Spanish
- •Child with BMI =/> 99%tile
- •Child with medical consequences of obesity (such as hypertension, hypercholesterolemia, insulin resistance, type 2 diabetes) that would require treatment and not prevention.
- •Child on medications (such as oral steroids, stimulants, or anti-psychotic medications) that can affect their weight status
- •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).
- •Parents who participated in interviews during the developmental phase of Helping HAND
- •Family currently participating in other weight treatment of prevention programs
Arms & Interventions
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).
Intervention: Helping HAND (Healthy Nutrition and Activity Directions) (Behavioral)
Intervention arm
see intervention description
Intervention: Helping HAND (Healthy Nutrition and Activity Directions) (Behavioral)
Investigators
Teresia O'Connor
Associate Professor, Pediatrics-Nutrition
Baylor College of Medicine