NCT00867373

Brief Summary

This pilot study is a randomized controlled trial with an embedded cross sectional study exploring parental perceptions of their weight status and how it affects their perceptions of their child's weight status. This study uses an educational intervention in which parents are informed of their actual weight status and how it affects their child's health. We will study the effect of this intervention on the parent's perceptions of and level of concern for their own and their child's weight status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

March 19, 2009

Last Update Submit

April 24, 2013

Conditions

Keywords

ObesityWeight perceptions

Outcome Measures

Primary Outcomes (1)

  • Proportion of parents correctly assessing their own weight status

    At first visit

Secondary Outcomes (5)

  • Proportion of parents correctly assessing their child's weight status

    At first visit

  • Proportion of parents who underestimate own weight status who also underestimate their child's weight status

    At first visit

  • Change in proportion of parents underestimating their own weight status

    At first visit and at one week follow up phone survey

  • Change in proportion of parents underestimating their child's weight status

    At first visit and at one week follow up phone survey

  • Change in level of concern pre- and post-intervention

    At first visit and at one week follow up phone survey

Study Arms (2)

Education Intervention

EXPERIMENTAL

The intervention used in the randomized controlled trial consists of 1) measuring the parents' height and weight and 2) providing the parents with feedback on their calculated BMI on an educational handout (included in Appendix V). The purpose of the handout is to convey the following 5 messages: 1. Definition of BMI 2. How BMI is calculated 3. What the parent's BMI is based on the measurements taken 4. What weight category the parent is in (underweight, normal weight, overweight, or obese) 5. Children with overweight or obese parents are at higher risk of becoming overweight themselves. The Research Assistant will verbally review the educational handout with the parent. The handout will be available in both English and Spanish.

Behavioral: Education Intervention

Control Group

NO INTERVENTION

Parents assigned to the control group will proceed to their child's well child visit after their baseline data are collected.

Interventions

The intervention is a short educational handout regarding BMI and the effect of parental weight status on children.

Education Intervention

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Boys and girls ages 3 to 13 years old presenting with at least one biological parent for a routine health maintenance exam (WCC) at the Child Health Continuity Clinic will be eligible. Parents must be able and willing to have their height and weight measured at the clinic

You may not qualify if:

  • Child has previously been referred to a nutritionist/dietician or specialized clinic/program for weight management
  • Child is currently being treated for failure to thrive
  • Child is on parenteral nutrition
  • Child is on chronic systemic steroid therapy
  • Child is non-mobile/wheelchair bound
  • The family has previously enrolled into the study with a prior sibling
  • Family is unable to be contacted at home
  • Presenting parent cannot speak and read English or Spanish at at least a 5th grade level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital

Aurora, Colorado, 80010, United States

Location

Related Publications (10)

  • Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

    PMID: 16595758BACKGROUND
  • Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.

    PMID: 15837955BACKGROUND
  • Rhee KE, De Lago CW, Arscott-Mills T, Mehta SD, Davis RK. Factors associated with parental readiness to make changes for overweight children. Pediatrics. 2005 Jul;116(1):e94-101. doi: 10.1542/peds.2004-2479.

    PMID: 15995022BACKGROUND
  • Logue E, Sutton K, Jarjoura D, Smucker W. Obesity management in primary care: assessment of readiness to change among 284 family practice patients. J Am Board Fam Pract. 2000 May-Jun;13(3):164-71. doi: 10.3122/15572625-13-3-164.

    PMID: 10826863BACKGROUND
  • Wee CC, Davis RB, Phillips RS. Stage of readiness to control weight and adopt weight control behaviors in primary care. J Gen Intern Med. 2005 May;20(5):410-5. doi: 10.1111/j.1525-1497.2005.0074.x.

    PMID: 15963162BACKGROUND
  • Eckstein KC, Mikhail LM, Ariza AJ, Thomson JS, Millard SC, Binns HJ; Pediatric Practice Research Group. Parents' perceptions of their child's weight and health. Pediatrics. 2006 Mar;117(3):681-90. doi: 10.1542/peds.2005-0910.

    PMID: 16510647BACKGROUND
  • Jeffery AN, Voss LD, Metcalf BS, Alba S, Wilkin TJ. Parents' awareness of overweight in themselves and their children: cross sectional study within a cohort (EarlyBird 21). BMJ. 2005 Jan 1;330(7481):23-4. doi: 10.1136/bmj.38315.451539.F7. Epub 2004 Nov 26. No abstract available.

    PMID: 15567804BACKGROUND
  • Birch LL, Fisher JO. Development of eating behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):539-49.

    PMID: 12224660BACKGROUND
  • Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available.

    PMID: 7287977BACKGROUND
  • Golan M, Weizman A, Apter A, Fainaru M. Parents as the exclusive agents of change in the treatment of childhood obesity. Am J Clin Nutr. 1998 Jun;67(6):1130-5. doi: 10.1093/ajcn/67.6.1130.

    PMID: 9625084BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Christina Suh, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
  • Nancy F. Krebs, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
  • Allison Kempe, MD, MPH

    Univeristy of Colorado Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 23, 2009

Study Start

May 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations