Pediatric ObesityRMI-FamilyNCT03527394
Motivation to Change Lifestyle Habits in Youth With Obesity
An observational study of Pediatric Obesity and Motivational Interviewing, run by University of Alberta at 2 sites in Canada.
Trial summary
Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Pediatric Obesity, Motivational Interviewing
- How many people
- 54 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Nov 2017to 31 Mar 2022
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Youth with obesity (BMI ≥97th percentile) and their parents. The study will be conducted at multiple sites within Alberta Health Services, including those families referred to and enrolled in multidisciplinary weight management clinics (Pediatric Centre for Weight and Health [PCWH]) at the Stollery Children's Hospital (Edmonton, AB) and Alberta Children's Hospital (Calgary, AB) and outpatient nutrition counseling for pediatric weight management (Edmonton, AB). The outpatient nutrition counseling occurs within clinic space at the PCWH in Edmonton, AB.
Who may be able to join
- 13-17 years old
- Youth with an age- and sex-specific BMI ≥97th percentile.
- Parents or guardians who self-identify as the primary caregiver of the youth and are able to provide in-depth perspective on youth lifestyle habits.
- Youth and parents who are proficient in English (reading and communicating).
Who cannot join
- <13 or >18 years old
- Youth with an age- and sex-specific BMI <97th percentile.
- Parents or guardians who do not self-identify as the youth primary caregiver or are not able to provide in-depth perspective on youth lifestyle habits.
- Families who are not proficient in English (reading and communicating).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Children's Hospital (Pediatric Centre for Weight and Health)
Calgary, Alberta
Stollery Children's Hospital (Pediatric Centre for Weight and Health)
Edmonton, Alberta
About this study
Official title: The Readiness and Motivation Interview for Families (RMI-Family) Managing Pediatric Obesity
Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Because current therapies for managing obesity have modest success, there is a need to develop and test innovative strategies to enhance pediatric weight management. Using a novel interview designed to measure motivation to change lifestyle habits, interviewers will conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By applying principles of motivational interviewing, trained interviewers will ask youth and their parents about their motivation to change lifestyle habits related to diet and physical activity. Subsequently, interview data will be used to examine predictors of clinically-meaningful outcomes over time, including changes in weight status, lifestyle habits, health care utilization, and attrition. The investigators will also measure a number of variables related to weight management, including dietary intake, physical activity, anthropometry, and psychosocial health.
Read the detailed description
The Readiness and Motivation Interview for Families (RMI-Family) was created as a structured interview for assessing youth and parent motivation (and within family member agreement) regarding lifestyle changes in pediatric weight management.
The RMI-Family was modeled on the Readiness and Motivation Interview (RMI), which was developed originally for use in the management of eating disorders (e.g., anorexia nervosa) and emerged as a 'gold standard' approach to assessing treatment motivation in that population. The RMI-Family was based on the tenets of motivational interviewing (MI), a directive, client-centered, and empirically-supported clinical approach to helping individuals resolve ambivalence about change across a range of lifestyle behaviours, including smoking, substance abuse, as well as diet and physical activity.
Participants will be recruited and enrolled into the study after being referred for pediatric weight management within Alberta Health Services, the governmental authority responsible for providing health care in the province of Alberta, Canada. Interviews will be completed following referral and before youth and parents initiative pediatric weight management. Each youth and parent will complete the RMI-Family (interview duration: 60 - 90 minutes) at baseline, 6-, and 12-months post-baseline. Individual (i.e., youth or parent) and family-level (i.e., across youth and parent) responses to interview questions will be scored, as will aspects of interview administration (e.g., fidelity to motivational interviewing tenets).
Families (youth+parent) will also complete the following questionnaires at baseline, 6- and 12-months follow-up:
- Behavior Assessment System for Children-Third Edition (BASC-3)
- Behavior Rating Inventory of Executive Function-Second Edition (BRIEF 2)
- Emotion Regulation Questionnaire (ERQ)
- Coping with Children's Negative Response Scale (CCNES)
- Marlowe-Crowne Social Desirability Scale (MC-SDS)
- Motivation to Change Rulers (Readiness to change lifestyle habits)
- Waterloo Eating Behaviour Questionnaire (WEB-Q)
- Dutch Eating Behaviour Questionnaire (DEBQ)
Physical activity will be measured for youth over a 7-day period using accelerometry, which will provide estimates of total movement time (and movement intensity) and sleep. Data regarding demography (e.g., gender, date of birth), anthropometry (e.g., height, weight), health services utilization (e.g., number of clinic appointments, length of appointments), and program attrition will be retrieved from medical records.
To ensure research team members who administer the RMI-Family interview adhere to principles of motivational interviewing (MI) (e.g., express and show empathy, roll with resistance, support autonomy, take curious and non-judgmental approach), the investigators implemented a number of training procedures before the study launched in fall, 2017. First, as background, all interviewers received and reviewed a package of information and resources (including sample videos) regarding MI, which covered a range of theoretical and practical issues. Second, all interviewers completed practice interviews using the RMI-Family with friends or colleagues that were audio-recorded for their own practice and self-reflection. Third, interviewers completed and audio-recorded 2 - 3 formal interviews (youth and parent versions), which were subsequently reviewed and evaluated by senior research team members with advanced training and expertise in psychology, counseling, and MI. Interviewers received feedback (both positive and constructive) about their interviews; when deemed necessary, interviewers completed additional interviews to build competence and skill, which were also reviewed by senior team members until they were confident that a similar and high level of proficiency was achieved by all interviewers.
To ensure interviewers maintain a high level of competence in administering the RMI-Family interview, all youth and parent interviews will be recorded (audio only) over the course of this study. After each interviewer completes 5 interviews, he/she will submit a randomly-selected interview for review by research team members to ensure implementation fidelity. To assess fidelity, the investigators will use the Motivational Interviewing Supervision and Training Scale (MISTS), which provides a behavioural count of interviewers' skills consistent with the principles of MI and assess the quality and fidelity with which the interview is administered. Subsequently, interviewers and reviewers will discuss issues related to clinical interactions and conversations; this formative approach is designed to optimize adherence to the MI interviewing practices over the course of the study.
- Conditions
- Pediatric Obesity, Motivational Interviewing
- Keywords
- Obesity, Pediatric, Parent, Family, Motivational Interviewing, Lifestyle, Health Behavior
- Medical subject headings
- Pediatric Obesity, Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Families | We plan to recruit a sample of 100 families (dyads) for this study, which will include 100 youth and 100 parents. Note: For the sake of transparency, this sample size differs from the original estimate (n=250 families; see Ball et al., BMC Health Serv Res, 2017;17:261). A recent systematic review (Park et al., Int J Nurs Stud, 2018;79:58-69) suggested that sample size estimates for studies that evaluate test-retest reliability (a key psychometric property we will examine) should include ~5 participants for every survey item. Given the design of the interview, and in light of current patient volumes at the clinical recruitment sites, we are confident that a sample of 100 families will be both achievable and satisfactory for psychometric analyses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline psychometric properties at 6- and 12-months
A number of psychometric properties of the Readiness and Motivation Interview for Families (RMI-Family) will be examined, including internal consistency, test-retest reliability, convergent validity, and concurrent validity. Based on data derived from the RMI-Family, we will generate youth, parent, and family (youth-parent) total motivation and motivation sub-scores (5-point Likert scale).
Measured: Baseline, 6- and 12-months post-baseline
Secondary outcomes (1)
Predictive value of the Readiness and Motivation Interview (RMI-Family)
Predictive validity of the RMI-Family will be examined by relating youth, parent, and family (youth-parent) scores (5-point Likert scale) from the interview to clinically-meaningful outcomes at baseline, 6- and 12-month follow-up, including anthropometry, lifestyle habits, psychosocial health, health care use, and program attrition.
Measured: Baseline, 6- and 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start6 Nov 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Geoff DC Ball, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527394
- Sponsor's protocol ID
- Pro00051447
- Acronym
- RMI-Family
- Status last verified
- May 2022
- First submitted
- 3 May 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geller J, Avis J, Srikameswaran S, Zelichowska J, Dartnell K, Scheuerman B, Perez A, Rasquinha A, Brown KE, Chanoine JP, Ball G. Developing and Pilot Testing the Readiness and Motivation Interview for Families in Pediatric Weight Management. Can J Diet Pract Res. 2015 Dec;76(4):190-3. doi: 10.3148/cjdpr-2015-024. Epub 2015 Aug 17.
PubMed 26280565Ball GD, Spence ND, Browne NE, O'Connor K, Srikameswaran S, Zelichowska J, Ho J, Gokiert R, Masse LC, Carson V, Morrison KM, Kuk JL, Holt NL, Kebbe M, Gehring ND, Cesar M, Virtanen H, Geller J. The readiness and motivation interview for families (RMI-Family) managing pediatric obesity: study protocol. BMC Health Serv Res. 2017 Apr 11;17(1):261. doi: 10.1186/s12913-017-2201-8.
PubMed 28399913
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Readiness and Motivation Interview for Families (RMI-Family) Managing Pediatric Obesity
- ClinicalTrials.gov ID
- NCT03527394
- Acronym / sponsor ID
- RMI-Family / Pro00051447
- Conditions
- Pediatric Obesity, Motivational Interviewing
- Keywords
- Obesity, Pediatric, Parent, Family, Motivational Interviewing, Lifestyle, Health Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Because current therapies for managing obesity have modest success, there is a need to develop and test innovative strategies to enhance pediatric weight management. Using a novel interview designed to measure motivation to change lifestyle habits, interviewers will conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By applying principles of motivational interviewing, trained interviewers will ask youth and their parents about their motivation to change lifestyle habits related to diet and physical activity. Subsequently, interview data will be used to examine predictors of clinically-meaningful outcomes over time, including changes in weight status, lifestyle habits, health care utilization, and attrition. The investigators will also measure a number of variables related to weight management, including dietary intake, physical activity, anthropometry, and psychosocial health.
Detailed description
The Readiness and Motivation Interview for Families (RMI-Family) was created as a structured interview for assessing youth and parent motivation (and within family member agreement) regarding lifestyle changes in pediatric weight management.
The RMI-Family was modeled on the Readiness and Motivation Interview (RMI), which was developed originally for use in the management of eating disorders (e.g., anorexia nervosa) and emerged as a 'gold standard' approach to assessing treatment motivation in that population. The RMI-Family was based on the tenets of motivational interviewing (MI), a directive, client-centered, and empirically-supported clinical approach to helping individuals resolve ambivalence about change across a range of lifestyle behaviours, including smoking, substance abuse, as well as diet and physical activity.
Participants will be recruited and enrolled into the study after being referred for pediatric weight management within Alberta Health Services, the governmental authority responsible for providing health care in the province of Alberta, Canada. Interviews will be completed following referral and before youth and parents initiative pediatric weight management. Each youth and parent will complete the RMI-Family (interview duration: 60 - 90 minutes) at baseline, 6-, and 12-months post-baseline. Individual (i.e., youth or parent) and family-level (i.e., across youth and parent) responses to interview questions will be scored, as will aspects of interview administration (e.g., fidelity to motivational interviewing tenets).
Families (youth+parent) will also complete the following questionnaires at baseline, 6- and 12-months follow-up:
- Behavior Assessment System for Children-Third Edition (BASC-3)
- Behavior Rating Inventory of Executive Function-Second Edition (BRIEF 2)
- Emotion Regulation Questionnaire (ERQ)
- Coping with Children's Negative Response Scale (CCNES)
- Marlowe-Crowne Social Desirability Scale (MC-SDS)
- Motivation to Change Rulers (Readiness to change lifestyle habits)
- Waterloo Eating Behaviour Questionnaire (WEB-Q)
- Dutch Eating Behaviour Questionnaire (DEBQ)
Physical activity will be measured for youth over a 7-day period using accelerometry, which will provide estimates of total movement time (and movement intensity) and sleep. Data regarding demography (e.g., gender, date of birth), anthropometry (e.g., height, weight), health services utilization (e.g., number of clinic appointments, length of appointments), and program attrition will be retrieved from medical records.
To ensure research team members who administer the RMI-Family interview adhere to principles of motivational interviewing (MI) (e.g., express and show empathy, roll with resistance, support autonomy, take curious and non-judgmental approach), the investigators implemented a number of training procedures before the study launched in fall, 2017. First, as background, all interviewers received and reviewed a package of information and resources (including sample videos) regarding MI, which covered a range of theoretical and practical issues. Second, all interviewers completed practice interviews using the RMI-Family with friends or colleagues that were audio-recorded for their own practice and self-reflection. Third, interviewers completed and audio-recorded 2 - 3 formal interviews (youth and parent versions), which were subsequently reviewed and evaluated by senior research team members with advanced training and expertise in psychology, counseling, and MI. Interviewers received feedback (both positive and constructive) about their interviews; when deemed necessary, interviewers completed additional interviews to build competence and skill, which were also reviewed by senior team members until they were confident that a similar and high level of proficiency was achieved by all interviewers.
To ensure interviewers maintain a high level of competence in administering the RMI-Family interview, all youth and parent interviews will be recorded (audio only) over the course of this study. After each interviewer completes 5 interviews, he/she will submit a randomly-selected interview for review by research team members to ensure implementation fidelity. To assess fidelity, the investigators will use the Motivational Interviewing Supervision and Training Scale (MISTS), which provides a behavioural count of interviewers' skills consistent with the principles of MI and assess the quality and fidelity with which the interview is administered. Subsequently, interviewers and reviewers will discuss issues related to clinical interactions and conversations; this formative approach is designed to optimize adherence to the MI interviewing practices over the course of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families | – | –We plan to recruit a sample of 100 families (dyads) for this study, which will include 100 youth and 100 parents. Note: For the sake of transparency, this sample size differs from the original estimate (n=250 families; see Ball et al., BMC Health Serv Res, 2017;17:261). A recent systematic review (Park et al., Int J Nurs Stud, 2018;79:58-69) suggested that sample size estimates for studies that evaluate test-retest reliability (a key psychometric property we will examine) should include ~5 participants for every survey item. Given the design of the interview, and in light of current patient volumes at the clinical recruitment sites, we are confident that a sample of 100 families will be both achievable and satisfactory for psychometric analyses. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Youth with obesity (BMI ≥97th percentile) and their parents. The study will be conducted at multiple sites within Alberta Health Services, including those families referred to and enrolled in multidisciplinary weight management clinics (Pediatric Centre for Weight and Health [PCWH]) at the Stollery Children's Hospital (Edmonton, AB) and Alberta Children's Hospital (Calgary, AB) and outpatient nutrition counseling for pediatric weight management (Edmonton, AB). The outpatient nutrition counseling occurs within clinic space at the PCWH in Edmonton, AB.
Key inclusion criteria (4 listed)
- 13-17 years old
- Youth with an age- and sex-specific BMI ≥97th percentile.
- Parents or guardians who self-identify as the primary caregiver of the youth and are able to provide in-depth perspective on youth lifestyle habits.
- Youth and parents who are proficient in English (reading and communicating).
Key exclusion criteria (4 listed)
- <13 or >18 years old
- Youth with an age- and sex-specific BMI <97th percentile.
- Parents or guardians who do not self-identify as the youth primary caregiver or are not able to provide in-depth perspective on youth lifestyle habits.
- Families who are not proficient in English (reading and communicating).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline psychometric properties at 6- and 12-months
Time frame: Baseline, 6- and 12-months post-baseline
A number of psychometric properties of the Readiness and Motivation Interview for Families (RMI-Family) will be examined, including internal consistency, test-retest reliability, convergent validity, and concurrent validity. Based on data derived from the RMI-Family, we will generate youth, parent, and family (youth-parent) total motivation and motivation sub-scores (5-point Likert scale).
1 secondary outcome
Predictive value of the Readiness and Motivation Interview (RMI-Family)
Time frame: Baseline, 6- and 12-months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 26280565Geller J, Avis J, Srikameswaran S, Zelichowska J, Dartnell K, Scheuerman B, Perez A, Rasquinha A, Brown KE, Chanoine JP, Ball G. Developing and Pilot Testing the Readiness and Motivation Interview for Families in Pediatric Weight Management. Can J Diet Pract Res. 2015 Dec;76(4):190-3. doi: 10.3148/cjdpr-2015-024. Epub 2015 Aug 17.
- Background: PubMed 28399913Ball GD, Spence ND, Browne NE, O'Connor K, Srikameswaran S, Zelichowska J, Ho J, Gokiert R, Masse LC, Carson V, Morrison KM, Kuk JL, Holt NL, Kebbe M, Gehring ND, Cesar M, Virtanen H, Geller J. The readiness and motivation interview for families (RMI-Family) managing pediatric obesity: study protocol. BMC Health Serv Res. 2017 Apr 11;17(1):261. doi: 10.1186/s12913-017-2201-8.
- The Readiness and Motivation Interview for Families (RMI-Family) Managing Pediatric Obesity: study protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff DC Ball, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Motivational Interviewing, run by University of Alberta at 2 sites in Canada.
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 4 inclusion and 4 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change from baseline psychometric properties at 6- and 12-months (time frame: Baseline, 6- and 12-months post-baseline). 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 NCT03527394, which also lists 2 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 31 May 2022.