Primary Care Child Obesity Intervention Targeting Parents

NCT01729910 | Completed

• 2 other identifiers: 1R15HD054950-01A2 REVISED1R15HD054950-01A2
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Overweight; Obesity

Keywords

overweight; obesity; rural; primary care

Outcome Measures

Primary Outcomes (1)

• child body mass index percentile

  6 months

Secondary Outcomes (1)

• Parent report of knowledge, attitudes, perceptions, intentions, and behaviors related to eating and physical activity

  6 months

Other Outcomes (1)

• Health care provider knowledge, attitudes, and practices related to child obesity management

  6-12 months

Study Arms (2)

Parent education / behavioral counseling

EXPERIMENTAL

Parents of children in the intervention group will be invited to participate in four group visits and two individual visits with their primary care provider as well as four follow-up phone calls with study personnel (project coordinator or registered dietician). 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.

Behavioral: Parent education / behavioral counseling

Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Interventions

Parent education / behavioral counseling BEHAVIORAL

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.

Parent education / behavioral counseling

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• BMI \>= 85th percentile
• age 5-11 years
• one parent or other primary care giver agrees to participate in the study

You may not qualify if:

• current participation in another weight management program by child or parent/caregiver
• presence of a diagnosed psychiatric/psychological disorder in the parent or child
• presence of an underlying condition affecting weight status
• current dietary or physical activity limitations
• parents who do not have phone accessibility

Sponsors & Collaborators

• East Tennessee State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Related Publications (2)

• Dalton WT 3rd, Schetzina KE, Holt N, Fulton-Robinson H, Ho AL, Tudiver F, McBee MT, Wu T. Parent-Led Activity and Nutrition (PLAN) for healthy living: design and methods. Contemp Clin Trials. 2011 Nov;32(6):882-92. doi: 10.1016/j.cct.2011.07.004. Epub 2011 Jul 18.

  PMID: 21777701 BACKGROUND

• Holt N, Schetzina KE, Dalton WT 3rd, Tudiver F, Fulton-Robinson H, Wu T. Primary care practice addressing child overweight and obesity: a survey of primary care physicians at four clinics in southern Appalachia. South Med J. 2011 Jan;104(1):14-9. doi: 10.1097/SMJ.0b013e3181fc968a.

  PMID: 21119559 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen E Schetzina, MD, MPH

  East Tennessee State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 20, 2012
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2011
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

US (1)