Primary Care Child Obesity Intervention Targeting Parents

NCT01729910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2015-11-24

No results posted yet for this study

Summary

Child overweight has become one of today's most important public health concerns. Engaged and skilled parenting that models, values, and encourages healthy eating habits and a physically active lifestyle can play a key role in childhood overweight prevention and reduction. Primary care providers are well positioned to intervene with children and their parents, but face many barriers in addressing child overweight. A child overweight treatment approach is proposed for the primary care setting to facilitate parents' active involvement and self-efficacy in promoting healthy eating habits and physical activity for their children. We will test the following hypotheses: Hypothesis I (primary hypothesis): Children assigned to the intervention group will improve more in weight status (measured by BMI percentile) than children in the control group. Hypothesis II: Primary care providers assigned to the intervention group will improve more in their competence in addressing child overweight than the providers in the control group. Hypothesis III: After the intervention, parents in the intervention group will have more involvement and self-efficacy in promoting healthy weight for their children than parents in the control group. Hypothesis IV: Compared to the control group, the intervention group will improve more in family diet and eating, physical activity behaviors, as well as parental attitude and beliefs. Eighty children five to eleven years old who are overweight or obese will be recruited from two pediatric and two family practice clinics in southern Appalachia. Children will be randomly assigned to intervention and control groups based on clinic affiliation. Parents of children in the intervention group will participate in four clinic-based group sessions using the NIH We Can! curriculum moderated by a trained clinic provider, two individual brief motivational interviewing visits with their clinic provider, and four follow-up phone calls with the project coordinator or registered dietician. Parenting behaviors and attitudes, and family eating and activity habits, and children's weight status will be assessed at baseline, at the completion of the intervention, and at six months after the intervention. Changes in the assessments will be compared between treatment and control groups. Changes in provider and parent attitudes and perceptions about this treatment approach,adherence to the program, and estimates of associated time will be measured.

Conditions

Interventions

BEHAVIORAL

Parent education / behavioral counseling

Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls. Training will be conducted by the PI and Co-Investigators using a combination of online, self-study, and face-to-face formats totally at least/approximately 8 hours. At least one project team member will attend each group visit. Specifically, the American Academy of Pediatrics 15-minute Obesity Prevention Protocol will be utilized during individual visits. The intervention is designed to take place over a period of 10-12 weeks in the primary care office.

BEHAVIORAL

Usual Care

Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • East Tennessee State University

    lead OTHER

Principal Investigators

  • Karen E Schetzina, MD, MPH · East Tennessee State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-11-30
Completion
2011-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729910 on ClinicalTrials.gov