Piloting Conversation Cards for Adolescents

NCT03821896 | Terminated

• 1 other identifier: Pro00083903
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Providers are not opportunistic enough in addressing lifestyle habits of teens, and can benefit from appropriate tools to support their conversations with families as well as engage all family members in making changes. Since most teens with obesity do not meet minimum lifestyle recommendations, our team developed Conversation Cards for Adolescents (CCAs), a tool to help teens and providers communicate and set lifestyle goals together. In this study, the investigators will (i) observe if and how CCAs fit in a clinical setting for changing teen-provider interactions and teens's lifestyle habits, (ii) ask teens and providers for their thoughts on CCAs and how they are used, and (iii) determine preliminary impact of CCAs on teen behaviors and clinical factors. The investigators will do this with around 50 teens from a primary/secondary care clinic in Edmonton, Alberta. Teens will be randomized to one of two groups - one group will use CCAs in their appointment with their providers to set a goal for change, while the other will also set a goal for change, but without using CCAs. Results from this study will give us insight into how CCAs are best used in a clinical setting and will help us plan a future full-scale study.

Conditions

Adolescent Obesity; Life Style; Health Behavior; Health Communication; Primary Health Care

Keywords

Adolescents; Obesity; Lifestyle; Goals; Communication

Outcome Measures

Primary Outcomes (1)

• Feasibility outcomes for resource, management, and scientific assessments per open-ended questions outlined by Tickle-Degnen's (2013)

  The study coordinator will monitor and document study procedures and feasibility based on continuous observation at the site.

  Through study completion, an average of 1 year

Secondary Outcomes (14)

• Collaborative goal-setting using the Patient Perception of Collaborative Goal-Setting

  Baseline

• Degree of effort and achievement of treatment goals using researcher-developed questions

  3 weeks

• Patient engagement: perspectives on priorities and study design using researcher-developed questions

  3 weeks

• Appointment length using a timer on the study-specific iPad

  Baseline

• User experience as per the User Experience Questionnaires

  Baseline (pre-appt)

Study Arms (2)

Conversation Cards for Adolescents and Goal-Setting

EXPERIMENTAL

Adolescents in the experimental arm will receive the tool 15 minutes prior to their appointment with their primary care provider. They will be instructed to familiarize themselves with the tool and to select the top 3 factors that resonate most with them in their attemps to change their lifestyle habits. They will then proceed to their clinical appointment to set one S.M.A.R.T. goal based on their selections and in collaboration with their primary care provider.

Behavioral: Conversation Cards for Adolescents and Goal-Setting

Goal-Setting

ACTIVE COMPARATOR

Adolescents in the control arm will not complete the tool activity, but will still set a S.M.A.R.T. goal with their primary care provider.

Behavioral: Goal-Setting

Interventions

Conversation Cards for Adolescents and Goal-Setting BEHAVIORAL

The intervention includes using an adolescent-tailored tool (a deck of cards) created by researchers at the University of Alberta and adolescents with obesity seeking weight management care. It contains a list of factors that make it easy or hard for teens to make and maintain healthy lifestyle changes. Its use will be paired with a S.M.A.R.T. goal-setting activity using principles of shared decision-making.

Conversation Cards for Adolescents and Goal-Setting

Goal-Setting BEHAVIORAL

Collaborative setting of S.M.A.R.T. goals using principles of shared decision-making.

Goal-Setting

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents are eligible to participate if they are:
• years old
• At a functioning grade level (English literacy and comprehension)
• Interested in setting a lifestyle/behavioural goal related to improving diet, physical activity or sedentary activity, and
• Seeking health services at the Northeast Community Health Centre (NECHC; Edmonton, Alberta, Canada)
• All participating providers who deliver care to adolescents at the NECHC are eligible to participate.

You may not qualify if:

• N/A
• Our original eligibility criteria included a BMI ≥85th percentile. After recruiting the first five patients with overweight/obesity from March to August 2019, we decided to remove BMI eligibility criteria given the applicability of our tool's focus on lifestyle and adolescents across the weight spectrum, as well as to enhance recruitment. This decision was made by the research team in conjunction with clinical staff involved in the trial.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Northeast Community Health Centre

Edmonton, Alberta, T5A 5E4, Canada

Location

Related Publications (18)

• Kebbe M, Damanhoury S, Browne N, Dyson MP, McHugh TF, Ball GDC. Barriers to and enablers of healthy lifestyle behaviours in adolescents with obesity: a scoping review and stakeholder consultation. Obes Rev. 2017 Dec;18(12):1439-1453. doi: 10.1111/obr.12602. Epub 2017 Sep 18.

  PMID: 28925065 BACKGROUND

• Kebbe M, Perez A, Buchholz A, McHugh TF, Scott SS, Richard C, Mohipp C, Dyson MP, Ball GDC. Barriers and enablers for adopting lifestyle behavior changes in adolescents with obesity: A multi-centre, qualitative study. PLoS One. 2018 Dec 18;13(12):e0209219. doi: 10.1371/journal.pone.0209219. eCollection 2018.

  PMID: 30562377 BACKGROUND

• Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

  PMID: 24570244 BACKGROUND

• Small L, Aplasca A. Child Obesity and Mental Health: A Complex Interaction. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):269-82. doi: 10.1016/j.chc.2015.11.008. Epub 2016 Jan 22.

  PMID: 26980129 BACKGROUND

• Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459.

  PMID: 29483202 BACKGROUND

• Tremblay MS, Feng M, Garriguet D, Ball GDC, Buchholz A, Chanoine JP, Lambert M, Morrison KM. Canadian Pediatric Weight Management Registry (CANPWR): baseline descriptive statistics and comparison to Canadian norms. BMC Obes. 2015 Aug 13;2:29. doi: 10.1186/s40608-015-0060-6. eCollection 2015.

  PMID: 26417450 BACKGROUND

• Ball GD, Lenk JM, Barbarich BN, Plotnikoff RC, Fishburne GJ, Mackenzie KA, Willows ND. Overweight children and adolescents referred for weight management: are they meeting lifestyle behaviour recommendations? Appl Physiol Nutr Metab. 2008 Oct;33(5):936-45. doi: 10.1139/H08-088.

  PMID: 18923569 BACKGROUND

• Wiegand S, Keller KM, Lob-Corzilius T, Pott W, Reinehr T, Robl M, Stachow R, Tuschy S, Weidanz I, Widhalm K, de Zwaan M, Holl RW. Predicting weight loss and maintenance in overweight/obese pediatric patients. Horm Res Paediatr. 2014;82(6):380-7. doi: 10.1159/000368963. Epub 2014 Dec 20.

  PMID: 25531074 BACKGROUND

• He M, Piche L, Clarson CL, Callaghan C, Harris SB. Childhood overweight and obesity management: A national perspective of primary health care providers' views, practices, perceived barriers and needs. Paediatr Child Health. 2010 Sep;15(7):419-26. doi: 10.1093/pch/15.7.419.

  PMID: 21886445 BACKGROUND

• McPherson AC, Hamilton J, Kingsnorth S, Knibbe TJ, Peters M, Swift JA, Krog K, Chen L, Steinberg A, Ball GD. Communicating with children and families about obesity and weight-related topics: a scoping review of best practices. Obes Rev. 2017 Feb;18(2):164-182. doi: 10.1111/obr.12485. Epub 2016 Nov 26.

  PMID: 27888564 BACKGROUND

• Ball GD, Farnesi BC, Newton AS, Holt NL, Geller J, Sharma AM, Johnson ST, Matteson CL, Finegood DT. Join the conversation! The development and preliminary application of conversation cards in pediatric weight management. J Nutr Educ Behav. 2013 Sep-Oct;45(5):476-8. doi: 10.1016/j.jneb.2013.02.002. Epub 2013 Apr 19. No abstract available.

  PMID: 23602164 BACKGROUND

• Arnold DM, Burns KE, Adhikari NK, Kho ME, Meade MO, Cook DJ; McMaster Critical Care Interest Group. The design and interpretation of pilot trials in clinical research in critical care. Crit Care Med. 2009 Jan;37(1 Suppl):S69-74. doi: 10.1097/CCM.0b013e3181920e33.

  PMID: 19104228 BACKGROUND

• Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009 May;62(5):499-505. doi: 10.1016/j.jclinepi.2009.01.012.

  PMID: 19348976 BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

• Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.

  PMID: 19348971 BACKGROUND

• Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrom M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, Jones R, Mitchell ED. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013 Feb 7;3(2):e002360. doi: 10.1136/bmjopen-2012-002360. Print 2013.

  PMID: 23396504 BACKGROUND

• Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

  PMID: 15189396 BACKGROUND

• Kebbe M, Farmer A, Dyson MP, Scott SD, McHugh TLF, Lappa S, Rajani H, Ladha T, Islam B, Jacoby L, Nasir F, Talwar K, Wincott JL, Zhang M, Ball GDC. Feasibility, user experiences, and preliminary effect of Conversation Cards for Adolescents(c) on collaborative goal-setting and behavior change: protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2019 Dec 18;5:149. doi: 10.1186/s40814-019-0533-3. eCollection 2019.

  PMID: 31890261 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Health Behavior; Obesity; Communication

Interventions

Organizational Objectives

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Geoff DC Ball, PhD, RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Maryam Kebbe, PhD

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An external party (Women and Children's Health Research Institute, University of Alberta) will run data analysis for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 30, 2019
• Study Start: March 15, 2019
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)