Childhood ObesityNCT01246349
Motivational Interviewing for Weight Loss
A study testing Motivational Interviewing (Treatment Group) in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The investigators studied the effect of motivational interviewing (MI) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Motivational Interviewing (Treatment Group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obese youth (with Body Mass Index (BMI) ≥ to 85th percentile for age and gender (as classified by the Center for Disease Control))
- ages 10-18 years
- attending a local obesity clinic ("Healthy Weights" clinic)
- Time of entry into the weight-loss program was controlled for; however, both new and current participants had the option to participate in the study.
Who cannot join
- taking medication whose side effects may influence weight gain or weight loss
- did not speak English
- demonstrated a developmental delay
- reported being pregnant and/or reported having an eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Interviewing as an Intervention to Increase Adolescent Self-Efficacy and Promote Weight Loss
The investigators studied the effect of motivational interviewing (MI) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years).
Read the detailed description
One empirically supported intervention with a large evidence base for improving adult outcomes in behavioral health-related disorders is Motivational Interviewing (MI). MI is strongly rooted in the client-centered therapy of Rogers (1951). Its relational stance emphasizes the importance of understanding the client's internal frame of reference and displaying unconditional positive regard for the client. Motivational interviewing can thus be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
Adolescent participants exposed to motivational interviewing in conjunction with usual care (diet and exercise program) are expected to endorse greater self-efficacy, report increased engagement in healthy behaviors, demonstrate a decrease in body weight and report improved psychological outcomes. While motivational interviewing has been shown to increase adults' motivation to make healthy behavior changes, few adolescent studies have demonstrated this effect.
- Conditions
- Childhood Obesity
- Being tested
- Motivational Interviewing (Treatment Group), Social Skills Training (Control Group)
- Keywords
- Motivational Interviewing, Child and Adolescent Self-Efficacy, Health Behaviours
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (Treatment Group)Behavioural
Motivational interviewing (MI) can be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
Social Skills Training (Control Group)Behavioural
Within the social skills training framework, advice is given to clients and sessions are focused on assigning goals for clients to work towards without specific regard for their readiness to change. The intervention is aimed at finding appropriate ways to navigate typical social situations (e.g., how to negotiate with parents).
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Group | Experimental | For the Motivational Interviewing (MI) treatment group, a clinical psychology doctoral student trained in Motivational Interviewing administered six individual motivational interviewing treatment sessions, each 30 minutes in length. Receives: Behavioral: Motivational Interviewing (Treatment Group) |
| Control Group | Active comparator | The comparison group received six social skills training sessions instead of Motivational Interviewing (MI). Receives: Behavioral: Social Skills Training (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Efficacy Life-style Questionnaire
A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, \& Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight.
The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident).
The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses.
The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined.
Measured: Baseline, 6 month follow-up
Child Dietary Self-Efficacy Scale
A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods.
The questionnaire is made up of 20 likert items with 3 response options, including "not sure", "a little sure", and "very sure". Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, "How sure are you that you could eat cereal instead of a donut?" Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy.
Measured: Baseline, 6 month follow-up
Secondary outcomes (3)
Physiological Outcomes: BMI
The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.
Measured: Baseline, 6 month follow-up
Physiological Outcomes: Waist Circumference
Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.
Measured: Baseline, 6 month follow-up
Psychological Well-being
Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)
Measured: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246349
- Sponsor's protocol ID
- 1000017625
- Status last verified
- Nov 2017
- First submitted
- 11 Nov 2010
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing as an Intervention to Increase Adolescent Self-Efficacy and Promote Weight Loss
- ClinicalTrials.gov ID
- NCT01246349
- Acronym / sponsor ID
- 1000017625
- Conditions
- Childhood Obesity
- Keywords
- Motivational Interviewing, Child and Adolescent Self-Efficacy, Health Behaviours
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators studied the effect of motivational interviewing (MI) on self-efficacy, health behaviors, and health outcomes in overweight children and adolescents (ages ranging from 10 to 18 years).
Detailed description
One empirically supported intervention with a large evidence base for improving adult outcomes in behavioral health-related disorders is Motivational Interviewing (MI). MI is strongly rooted in the client-centered therapy of Rogers (1951). Its relational stance emphasizes the importance of understanding the client's internal frame of reference and displaying unconditional positive regard for the client. Motivational interviewing can thus be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
Adolescent participants exposed to motivational interviewing in conjunction with usual care (diet and exercise program) are expected to endorse greater self-efficacy, report increased engagement in healthy behaviors, demonstrate a decrease in body weight and report improved psychological outcomes. While motivational interviewing has been shown to increase adults' motivation to make healthy behavior changes, few adolescent studies have demonstrated this effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Group | Experimental | Behavioral: Motivational Interviewing (Treatment Group)For the Motivational Interviewing (MI) treatment group, a clinical psychology doctoral student trained in Motivational Interviewing administered six individual motivational interviewing treatment sessions, each 30 minutes in length. |
| Control Group | Active comparator | Behavioral: Social Skills Training (Control Group)The comparison group received six social skills training sessions instead of Motivational Interviewing (MI). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Obese youth (with Body Mass Index (BMI) ≥ to 85th percentile for age and gender (as classified by the Center for Disease Control))
- ages 10-18 years
- attending a local obesity clinic ("Healthy Weights" clinic)
- Time of entry into the weight-loss program was controlled for; however, both new and current participants had the option to participate in the study.
Key exclusion criteria (4 listed)
- taking medication whose side effects may influence weight gain or weight loss
- did not speak English
- demonstrated a developmental delay
- reported being pregnant and/or reported having an eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing (Treatment Group)Motivational interviewing (MI) can be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting. | Behavioural | Motivational Interviewing Group |
| Social Skills Training (Control Group)Within the social skills training framework, advice is given to clients and sessions are focused on assigning goals for clients to work towards without specific regard for their readiness to change. The intervention is aimed at finding appropriate ways to navigate typical social situations (e.g., how to negotiate with parents). | Behavioural | Control Group |
Primary outcome
Weight Efficacy Life-style Questionnaire
Time frame: Baseline, 6 month follow-up
A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, \& Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight. The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident). The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses. The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined.
Child Dietary Self-Efficacy Scale
Time frame: Baseline, 6 month follow-up
A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods. The questionnaire is made up of 20 likert items with 3 response options, including "not sure", "a little sure", and "very sure". Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, "How sure are you that you could eat cereal instead of a donut?" Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy.
3 secondary outcomes
Physiological Outcomes: BMI
Time frame: Baseline, 6 month follow-up
Physiological Outcomes: Waist Circumference
Time frame: Baseline, 6 month follow-up
Psychological Well-being
Time frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jill Hamilton, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (Treatment Group) in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Efficacy Life-style Questionnaire (time frame: Baseline, 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.