NCT02330588

Brief Summary

Childhood obesity is an urgent public health issue. Roughly one-quarter of Canadian children are overweight, putting them at risk for chronic diseases. Because most families access health services in primary care, it is an ideal venue for obesity prevention. Specifically, programs in primary care can prevent unhealthy weight gain in healthy weight children (primary prevention) AND reduce unhealthy weight gain in children who are already overweight (secondary prevention). Parents play a key role in children's health, so it is vital to include parents in strategies to prevent childhood obesity. The following objectives of this study are to: (i) develop a web-based, brief program for parents as an educational tool to motivate parents to support healthy lifestyles in children, and access community resources and health services that can prevent childhood obesity; (ii) assess the acceptability of the program using focus groups with parents, and pediatric-focused health care professionals, trainees, and administrators; and (iii) recruit parents (n=200) in primary care and collect data at baseline and 1-month follow-up to explore if the program led to changes in parents' motivation to support their children's lifestyle habits, and families' use of resources and health services to prevent childhood obesity. It is hypothesized that the developed screening, brief intervention, and referral to treatment (SBIRT) will (i) encourage parents of healthy weight children to seek resources to eat healthfully and be physically active to maintain their weight status (primary \[1°\] prevention), and (ii) guide parents of unhealthy weight children to access educational tools and community services to reduce their child's obesity and associated health risks (secondary \[2°\] prevention). By providing families with tailored feedback, practical educational tools, and information on local health services, this research will help to address oft-cited barriers primary care clinicians commonly report when providing effective obesity-related health services, and encourage family self-management of obesity-related behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

December 17, 2014

Results QC Date

November 16, 2016

Last Update Submit

March 5, 2017

Conditions

Keywords

ObesityPreventionPediatricParentsPrimary CareeHealthInternet

Outcome Measures

Primary Outcomes (2)

  • Feasibility (Parents' Interest in the SBIRT.)

    Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) 'opted in' to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.

    Baseline

  • Feasibility (Parents' Uptake of the SBIRT)

    Parents' uptake was determined by parents' use (actual and self-reported) of obesity prevention resources (i.e., the proportion \[reported in percentage\] that actually or self-reported using resources out of the total number of participants that participated in follow-up), and the proportion (reported in percentage) of parents that reported discussing children's weight with their pediatrician immediately following the SBIRT.

    One-month follow-up

Secondary Outcomes (1)

  • Parents' Concern About Children's Weight Status and Motivation to Change Lifestyle Behaviors Immediately Following the SBIRT.

    Measured at baseline

Study Arms (5)

Eat It! (Injunctive Feedback)

EXPERIMENTAL

Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).

Behavioral: Eat It

Eat It! (Normative Feedback)

EXPERIMENTAL

Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).

Behavioral: Eat It

Move It! (Injunctive Feedback)

EXPERIMENTAL

Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).

Behavioral: Move It

Move It! (Normative Feedback)

EXPERIMENTAL

Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).

Behavioral: Move It

eHealth Control

PLACEBO COMPARATOR

Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).

Behavioral: eHealth Control

Interventions

Eat ItBEHAVIORAL

The SBIRT (Screening, Brief Intervention, Referral to Treatment), called RIPPLE (Resource Information Program for Parents on Lifestyle Education) was delivered on a study-designated tablet and designed to (1) screen children's weight status, (2) deliver a brief intervention\*, and (3) provide parents with the opportunity select resources and services to help prevent obesity in children. \*Two brief questions about children's grain portion sizes and sugar sweetened beverage intake were presented.

Eat It! (Injunctive Feedback)Eat It! (Normative Feedback)
Move ItBEHAVIORAL

The SBIRT (Screening, Brief Intervention, Referral to Treatment), called RIPPLE (Resource Information Program for Parents on Lifestyle Education) was delivered on a study-designated tablet and designed to (1) screen children's weight status, (2) deliver a brief intervention\*, and (3) provide parents with the opportunity select resources and services to help prevent obesity in children. \*Two brief questions about children's moderate-to-vigorous physical activity (MVPA) and screen time were presented.

Move It! (Injunctive Feedback)Move It! (Normative Feedback)
eHealth ControlBEHAVIORAL

The eHealth Control group (1) screened children's weight status, and (2) provided parents with the opportunity select resources and services to help prevent obesity in children.

Also known as: Heads Up
eHealth Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • parents of children 5-17 years of age
  • parents speak and read English

You may not qualify if:

  • children present with urgent medical issues (e.g., febrile, acute asthma attack)
  • children attend appointment without legal guardian
  • parents do not have sufficient time (15-20 minutes) to complete the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Allin Clinic, Edmonton Oliver Primary Care Network

Edmonton, Alberta, T5K 2A2, Canada

Location

Related Publications (2)

  • Campbell M, Benton JM, Werk LN. Parent perceptions to promote a healthier lifestyle for their obese child. Soc Work Health Care. 2011;50(10):787-800. doi: 10.1080/00981389.2011.597316.

  • Avis JL, Cave AL, Donaldson S, Ellendt C, Holt NL, Jelinski S, Martz P, Maximova K, Padwal R, Wild TC, Ball GD. Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study. JMIR Res Protoc. 2015 Mar 25;4(1):e35. doi: 10.2196/resprot.4147.

Related Links

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

(1) The SBIRT did not include data collection of parents' self-reported concern and intention pre- and post-intervention, and (2) the study was developmental in nature and was not sufficiently powered to detect group differences.

Results Point of Contact

Title
Dr. Geoff Ball
Organization
Department of Pediatrics, University of Alberta

Study Officials

  • Geoff DC Ball, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 5, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

April 17, 2017

Results First Posted

April 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations