NCT02067728

Brief Summary

The main aim of the study would be to examine the effect of using a health behavior screening tool and a brief patient centered conversation on health behavior goal setting during well-child visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 23, 2016

Completed
Last Updated

March 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

February 16, 2014

Results QC Date

November 19, 2015

Last Update Submit

February 22, 2016

Conditions

Obesity

Keywords

obesity prevention

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Documented Goal Setting

    Health behavior change goal documented in charting of well-child visits.

    2 weeks from encounter

Secondary Outcomes (8)

  • Obesiogenic Goal Setting Success

    1 month after the encounter

  • Obesiogenic Goal Setting Success

    6 months after encounter

  • Success of Obesiogenic Goals

    1 month post encounter

  • Success of Obesiogenic Goals

    6 months post encounter

  • Success of Other Health Goals

    1 month post encounter

  • +3 more secondary outcomes

Other Outcomes (3)

  • BMI Z-score Change for All

    Baseline and 6 months after the encounter

  • Perception of Patient Centeredness of Encounter

    1 month after the encounter

  • Obesity Follow-up Adherence

    6 months after the encounter

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool

Behavioral: Usual Care

FNPA tool intervention

EXPERIMENTAL

FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.

Behavioral: FNPA tool

Interventions

FNPA toolBEHAVIORAL

Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits.

FNPA tool intervention
Usual CareBEHAVIORAL

Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits.

Usual Care

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- All children ages 4-17 years scheduled for well child visits

You may not qualify if:

  • Patients with chronic medical conditions or developmental delays that preclude age appropriate nutrition and physical activity habits will be excluded. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UnityPointHealth Methodist in Peoria

Peoria, Illinois, 61636, United States

Location

Related Publications (17)

  • Campbell K, Waters E, O'Meara S, Summerbell C. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2001;(3):CD001871. doi: 10.1002/14651858.CD001871.

    PMID: 11686999BACKGROUND

  • Gutnick D. Brief Action Planning to Facilitate Behavior Change and Support Patient Self-Management.Journal of Clinical Outcomes Management 21(1):17-29, 2014

    BACKGROUND

  • Taveras EM, Gortmaker SL, Hohman KH, Horan CM, Kleinman KP, Mitchell K, Price S, Prosser LA, Rifas-Shiman SL, Gillman MW. Randomized controlled trial to improve primary care to prevent and manage childhood obesity: the High Five for Kids study. Arch Pediatr Adolesc Med. 2011 Aug;165(8):714-22. doi: 10.1001/archpediatrics.2011.44. Epub 2011 Apr 4.

    PMID: 21464376BACKGROUND

  • Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.

    PMID: 18055651BACKGROUND

  • Huang JS, Donohue M, Golnari G, Fernandez S, Walker-Gallego E, Galvan K, Briones C, Tamai J, Becerra K. Pediatricians' weight assessment and obesity management practices. BMC Pediatr. 2009 Mar 5;9:19. doi: 10.1186/1471-2431-9-19.

    PMID: 19265553BACKGROUND

  • Perrin EM, Flower KB, Garrett J, Ammerman AS. Preventing and treating obesity: pediatricians' self-efficacy, barriers, resources, and advocacy. Ambul Pediatr. 2005 May-Jun;5(3):150-6. doi: 10.1367/A04-104R.1.

    PMID: 15913408BACKGROUND

  • Story MT, Neumark-Stzainer DR, Sherwood NE, Holt K, Sofka D, Trowbridge FL, Barlow SE. Management of child and adolescent obesity: attitudes, barriers, skills, and training needs among health care professionals. Pediatrics. 2002 Jul;110(1 Pt 2):210-4.

    PMID: 12093997BACKGROUND

  • Berg-Smith SM, Stevens VJ, Brown KM, Van Horn L, Gernhofer N, Peters E, Greenberg R, Snetselaar L, Ahrens L, Smith K. A brief motivational intervention to improve dietary adherence in adolescents. The Dietary Intervention Study in Children (DISC) Research Group. Health Educ Res. 1999 Jun;14(3):399-410. doi: 10.1093/her/14.3.399.

    PMID: 10539230BACKGROUND

  • Erickson SJ, Gerstle M, Feldstein SW. Brief interventions and motivational interviewing with children, adolescents, and their parents in pediatric health care settings: a review. Arch Pediatr Adolesc Med. 2005 Dec;159(12):1173-80. doi: 10.1001/archpedi.159.12.1173. No abstract available.

    PMID: 16330743BACKGROUND

  • Taveras EM, Mitchell K, Gortmaker SL. Parental confidence in making overweight-related behavior changes. Pediatrics. 2009 Jul;124(1):151-8. doi: 10.1542/peds.2008-2892.

    PMID: 19564295BACKGROUND

  • Schwartz RP, Hamre R, Dietz WH, Wasserman RC, Slora EJ, Myers EF, Sullivan S, Rockett H, Thoma KA, Dumitru G, Resnicow KA. Office-based motivational interviewing to prevent childhood obesity: a feasibility study. Arch Pediatr Adolesc Med. 2007 May;161(5):495-501. doi: 10.1001/archpedi.161.5.495.

    PMID: 17485627BACKGROUND

  • Bodenheimer T, Handley MA. Goal-setting for behavior change in primary care: an exploration and status report. Patient Educ Couns. 2009 Aug;76(2):174-80. doi: 10.1016/j.pec.2009.06.001. Epub 2009 Jun 27.

    PMID: 19560895BACKGROUND

  • Shilts MK, Horowitz M, Townsend MS. Goal setting as a strategy for dietary and physical activity behavior change: a review of the literature. Am J Health Promot. 2004 Nov-Dec;19(2):81-93. doi: 10.4278/0890-1171-19.2.81.

    PMID: 15559708BACKGROUND

  • Gans KM, Ross E, Barner CW, Wylie-Rosett J, McMurray J, Eaton C. REAP and WAVE: new tools to rapidly assess/discuss nutrition with patients. J Nutr. 2003 Feb;133(2):556S-62S. doi: 10.1093/jn/133.2.556S.

    PMID: 12566502BACKGROUND

  • Patrick K, Sallis JF, Prochaska JJ, Lydston DD, Calfas KJ, Zabinski MF, Wilfley DE, Saelens BE, Brown DR. A multicomponent program for nutrition and physical activity change in primary care: PACE+ for adolescents. Arch Pediatr Adolesc Med. 2001 Aug;155(8):940-6. doi: 10.1001/archpedi.155.8.940.

    PMID: 11483123BACKGROUND

  • Ihmels MA, Welk GJ, Eisenmann JC, Nusser SM. Development and preliminary validation of a Family Nutrition and Physical Activity (FNPA) screening tool. Int J Behav Nutr Phys Act. 2009 Mar 12;6:14. doi: 10.1186/1479-5868-6-14.

    PMID: 19284631BACKGROUND

  • Ihmels MA, Welk GJ, Eisenmann JC, Nusser SM, Myers EF. Prediction of BMI change in young children with the family nutrition and physical activity (FNPA) screening tool. Ann Behav Med. 2009 Aug;38(1):60-8. doi: 10.1007/s12160-009-9126-3. Epub 2009 Oct 6.

    PMID: 19806417BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Amy L. Christison
Organization
University of Illinois College of Medicine at Peoria
alc@uicomp.uic.edu
309-655-3613

Study Officials

  • Amy Christison, MD

    University of Illinois College of Medicine at Peoria

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 23, 2016

Results First Posted

March 23, 2016

Record last verified: 2016-02

Locations

US(1)