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ObesityNCT00867373

Parent Perceptions of Weight Status: Impact of a Pilot Intervention

A study testing Education Intervention in people with Obesity, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 13 years
Conditions the study is for
Obesity
What is being tested?
Education Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
1 siteUnited States
Study dates
May 2007to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1. 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Children's Hospital

    Aurora, Colorado, 80010

Other trials in United States

About this study

Official title: Parent Perceptions of Weight Status: Impact of a Pilot Intervention to Enhance Awareness of Risk for Overweight Parents and Their Children

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.

Read the detailed description

Pediatric obesity has tripled in the past 20 years. Obesity prevention early in life is important and parental participation is essential. Parents must recognize overweight in their child so health providers may engage them in a dialogue to change their child's diet and physical activity patterns, yet a large proportion of parents do not recognize that their child is overweight. Parents' misperception of their overweight child's weight status presents a barrier to treating obesity.

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.

Our goal is to develop a primary care intervention that will enhance parental perceptions of overweight and motivation to make changes for their family. Pilot data collected here will support an R21 Exploratory/Developmental Clinical Research Grant in Obesity or a Centers for Disease Control (CDC) or Robert Wood Johnson Foundation (RWJ) grant submission.

Conditions
Obesity
Being tested
Education Intervention
Keywords
Obesity, Weight perceptions
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education InterventionBehavioural

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

Study groups in NCT00867373
Study groupRoleWhat they receive
Education InterventionExperimentalThe 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.
Receives: Behavioral: Education Intervention
Control GroupNo interventionParents assigned to the control group will proceed to their child's well child visit after their baseline data are collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of parents correctly assessing their own weight status

    Measured: At first visit

Secondary outcomes (5)

  1. Proportion of parents correctly assessing their child's weight status

    Measured: At first visit

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

    Measured: At first visit

  3. Change in proportion of parents underestimating their own weight status

    Measured: At first visit and at one week follow up phone survey

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

    Measured: At first visit and at one week follow up phone survey

  5. Change in level of concern pre- and post-intervention

    Measured: At first visit and at one week follow up phone survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2009 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00867373
Sponsor's protocol ID
07-0329
Status last verified
Apr 2013
First submitted
19 Mar 2009
Last updated
26 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16595758

  • 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.

    PubMed 15837955

  • 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.

    PubMed 15995022

  • 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.

    PubMed 10826863

  • 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.

    PubMed 15963162

  • 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.

    PubMed 16510647

  • 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.

    PubMed 15567804

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

    PubMed 12224660

  • 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.

    PubMed 7287977

  • 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.

    PubMed 9625084

Questions about this trial

What is this clinical trial studying?

A study testing Education Intervention in people with Obesity, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of parents correctly assessing their own weight status (time frame: At first visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00867373, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.

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