The Resource Information Program for Parents on Lifestyle and Education

Pediatric Obesity Clinical Trial

— RIPPLE  

Official title:

Working With Parents to Prevent Childhood Obesity: A Primary Care-based Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02330588
• Other study ID #: RIPPLE-0613
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2014
• Last updated: December 31, 2014
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Alberta
• Contact: Geoff DC Ball, PhD
• Phone: 780-492-8727
• Email: gdball[@]ualberta.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Background: There is urgent need to develop and evaluate innovative, evidence-based, and sustainable approaches for pediatric obesity in accessible settings. One such approach, the screening, brief intervention, and referral to treatment (SBIRT), has been used to address preventable health concerns, such as hazardous drinking; this time- and resource-limited approach delivers a brief, theoretically-driven intervention to increase awareness of a health concern and provides the respondent with feedback and information on relevant resources. This approach is suited to obesity prevention as it can enhance parents' awareness and concern for children's lifestyle behaviors, remove social barriers and provide anonymity for families, and overcome limited availability of obesity-related health services.

Setting. This study will take place at a centrally-located Edmonton pediatric clinic housed within the Edmonton Oliver Primary Care Network (EOPCN). Primary care (PC) represents an accessible, relevant, and appropriate venue to prevent pediatric obesity because (i) PC often represents families' first point of contact with the health care system, (ii) the goals and priorities of PC clinics are well-aligned with primary and secondary prevention of chronic diseases, and (iii) patients typically access health care services throughout the life course, therefore representing a suitable environment to capture longitudinal data.

Phase I. The objective of this phase is to develop a web-based, theoretically-driven SBIRT to enhance parents' awareness, concern for, and motivation to support children's lifestyle behaviors. The SBIRT (RIPPLE; the Resource Information Program for Parents on Lifestyle and Education) will screen children of all weight statuses, deliver a brief intervention regarding children's lifestyle behaviors to parents, and provide parents with a menu of resources and community resources to facilitate the prevention of obesity in children. The intervention has been informed by the Norm Activation Model, and a survey following the intervention will test psychosocial constructs from the Theory of Planned Behavior and Health Belief Model. Parents will receive a personalized report based on their intervention responses and selected resources and services; parents will have the option to email this report to themselves.

Phase II. The objective of this phase is to refine the SBIRT using focus groups. Participants (n=30) will include parents, and pediatric-focused administrators, health care providers, research coordinators, and graduate trainees. Focus groups will query participants' overall perceptions of the program; specifically, impressions regarding likability, acceptability, satisfaction, and feasibility of incorporating the intervention into clinical practice. Focus group discussions will be transcribed in real-time using a court reporter, which will optimize transcription accuracy and ensure confidentiality. The method of Qualitative Description (QD) will be used to develop a rich and explicit description of the phenomena. QD necessitates less interpretive interference on behalf of the researcher, therefore representing an accurate and realistic embodiment of participants' discussion.

Phase III (RCT). The objective of this phase is to recruit parents (n=200) from a pediatric primary care clinic to enroll in the RCT. This double-blinded, parallel-design RCT will adhere to CONSORT guidelines. The allocation sequence will be electronically generated and blocked randomization (5 arms; block size of five) will be used to ensure equal group sizes throughout the study. Research assistants will be blinded to participants' intervention assignment and participants will not be aware if they have received the intervention or control.

Parents will be eligible for the study if they speak and read English, and have a 5 - 17 year old child who is present at the appointment with a non-urgent medical issue. Data will be collected at (i) baseline during delivery of the online RCT and (ii) 1-month follow-up to assess time-related changes in parents' psychosocial constructs (e.g., intention to change children's lifestyle behaviors; primary outcome) and families' utilization of resources and health services to facilitate healthy lifestyle behaviors (secondary outcome). Follow-up will include email delivery of a survey measure identical to that administered at baseline. Given rates of attrition tend to increase over time parents' access to the online personalized report will serve as a proxy of participation if the online survey is not completed.

Continuous variables will be described by univariate summaries; frequency distributions will be determined for categorical variables. Participant characteristics (e.g., weight status, child sex) will be examined to assess equivalence of intervention groups at baseline, and attrition tendencies across sub-groups will be examined using two-way ANOVA. Multilevel modelling will be used to assess intra- and inter-level individual and group change in the primary and secondary outcomes; this form of analysis is appropriate when observations are nested within groups and/or multiple time points. Estimates of effect sizes will be based on percent change in primary outcomes. Significance will be p<0.05.

Significance & Future Directions. The SBIRT is designed to encourage self-management by providing families with tailored feedback and linking them with appropriate and relevant resources to facilitate children's healthy lifestyle behaviors. Findings from this study will inform future intervention refinement and implementation into everyday clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• parents of children 5-17 years of age

• parents speak and read English

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Chow Down! (Injunctive Feedback)
Our nutrition-based brief intervention (Chow Down!) includes two questions for parents to answer regarding perceptions of their children's diet; one question relates to portion sizes of grain products and another queries intake of sugar-sweetened beverages. Parents' responses to the intervention questions will be compared to injunctive data; for example, national recommendations (e.g., Canada's Food Guide).
• Chow Down! (Normative Feedback)
Our nutrition-based brief intervention (Chow Down!) includes two questions for parents to answer regarding perceptions of their children's diet; one question relates to portion sizes of grain products and another queries intake of sugar-sweetened beverages. Parents' responses to the intervention questions will be compared to normative data from the Canadian pediatric population (e.g., Canadian Health Measures Survey).
• Move It! (Injunctive Feedback)
Our physical activity-based brief intervention (Move It!) includes two questions for parents to answer regarding children's physical activity; one question relates to the duration of daily moderate-to-vigorous physical activity and another queries the amount of daily screen time. Parents' responses to the intervention questions will be compared to injunctive data; for example national recommendations (e.g., Canadian Physical Activity Guidelines for Children and Youth).
• Move It! (Normative Feedback)
Our physical activity-based brief intervention (Move It!) includes two questions for parents to answer regarding children's physical activity; one question relates to the duration of daily moderate-to-vigorous physical activity and another queries the amount of daily screen time. Parents' responses to the intervention questions will be compared to normative data from the Canadian pediatric population (e.g., Canadian Health Measures Survey).
• Heads Up!
Parents assigned to the control group will be presented with information about healthy lifestyle behaviors for children in general, but intervention questions will not be delivered.

Locations

Country	Name	City	State
Canada	The Allin Clinic, Edmonton Oliver Primary Care Network	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions, Canadian Institutes of Health Research (CIHR), Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in parents' concern for and motivation to support their child's healthy lifestyle behaviors, as measured by a theory-based questionnaire* administered at baseline and one-month follow-up.	A brief, eight-item Likert scale questionnaire with established face validity has been adopted from Campbell et al. (2011) and will assess parents' concern for and motivation to support their child's lifestyle behaviors. Specifically, parents assigned to the brief nutrition-based intervention (Chow Down!) will receive questions that query their concern for, and importance and confidence to change their child's dietary habits, and parents assigned to the brief physical activity-based intervention (Move It!) will receive questions that query their concern for, and importance and confidence to change their child's physical activity habits; parents assigned to the control group (Heads Up!) will receive both sets of questions.; 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.	Measured at one-month following the baseline assessment	No
Secondary	Health services and educational resources utilization at one-month follow-up		Measured at one-month following the baseline assessment	No
Secondary	Retention rate across arms at one-month follow-up		Measured at one-month following the baseline assessment	No

External Links

•   eHealth intervention development company
•   Study-dedicated blog to provide updates and news to research team