Trial Outcomes & Findings for Motivational Interviewing for Weight Loss (NCT NCT01246349)
NCT ID: NCT01246349
Last Updated: 2017-11-17
Results Overview
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.
COMPLETED
NA
40 participants
Baseline, 6 month follow-up
2017-11-17
Participant Flow
Overweight and obese youth (BMI ≥ 85th %ile for age and gender) were eligible to participate and were recruited directly by the primary investigators from the Toronto East General Hospital's Healthy Lifestyles program, comprised of children and adolescents ages 10-18 years who are seeking diet and exercise treatment for their obesity.
Individuals were excluded if they: 1) were taking medication whose side effects may influence weight gain or weight loss, 2) did not speak English, 3) had a known developmental delay, and 4) reported being pregnant and/or having an active eating disorder.
Participant milestones
| Measure |
Control Group
The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).
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Treatment/Experimental Group
The Treatment group received Motivational Interviewing (MI). MI is 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.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.
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|---|---|---|
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Overall Study
STARTED
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20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Motivational Interviewing for Weight Loss
Baseline characteristics by cohort
| Measure |
Treatment Group (Motivational Interviewing)
n=20 Participants
The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client's intrinsic motivation to change by exploring and resolving ambivalence.
MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.
Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student.
|
Control (Social Skills Training)
n=20 Participants
The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.
The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients' readiness to change was made in this group.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
13.7 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
13.9 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow-upA 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.
Outcome measures
| Measure |
Control Group
n=20 Participants
The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).
|
Motivational Interviewing Group
n=20 Participants
The Treatment group received Motivational Interviewing (MI). MI is 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.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.
|
|---|---|---|
|
Weight Efficacy Life-style Questionnaire
Baseline WEL
|
120.70 scores on a scale
Standard Deviation 29.32
|
128.80 scores on a scale
Standard Deviation 27.24
|
|
Weight Efficacy Life-style Questionnaire
Follow-up WEL
|
139.88 scores on a scale
Standard Deviation 19.88
|
136.40 scores on a scale
Standard Deviation 26.77
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow-upA 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.
Outcome measures
| Measure |
Control Group
n=20 Participants
The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).
|
Motivational Interviewing Group
n=20 Participants
The Treatment group received Motivational Interviewing (MI). MI is 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.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.
|
|---|---|---|
|
Child Dietary Self-Efficacy Scale
Baseline CDSS
|
9.35 scores on a scale
Standard Deviation 3.28
|
9.42 scores on a scale
Standard Deviation 4.53
|
|
Child Dietary Self-Efficacy Scale
Follow-up CDSS
|
8.59 scores on a scale
Standard Deviation 3.26
|
8.55 scores on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Baseline, 6 month follow-upThe 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.
Outcome measures
| Measure |
Control Group
n=20 Participants
The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).
|
Motivational Interviewing Group
n=20 Participants
The Treatment group received Motivational Interviewing (MI). MI is 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.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.
|
|---|---|---|
|
Physiological Outcomes: BMI
Baseline BMI
|
2.64 z-score
Standard Deviation 0.73
|
2.51 z-score
Standard Deviation 0.47
|
|
Physiological Outcomes: BMI
Follow-up BMI
|
2.41 z-score
Standard Deviation 0.78
|
2.46 z-score
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline, 6 month follow-upMeasurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.
Outcome measures
| Measure |
Control Group
n=20 Participants
The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.
The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients' readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends).
|
Motivational Interviewing Group
n=20 Participants
The Treatment group received Motivational Interviewing (MI). MI is 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.
A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length.
|
|---|---|---|
|
Physiological Outcomes: Waist Circumference
Baseline Waist Circumference
|
95.7 cm
Standard Deviation 11.4
|
92.8 cm
Standard Deviation 6.6
|
|
Physiological Outcomes: Waist Circumference
Follow-up Waist Circumference
|
93.6 cm
Standard Deviation 10.9
|
94.35 cm
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessmentRosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Motivational Interviewing Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place