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Motivational Interviewing for Weight Loss

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ClinicalTrials.gov Identifier: NCT01246349
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : April 21, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

November 11, 2010
November 23, 2010
January 17, 2014
April 21, 2014
November 17, 2017
September 2010
July 2012   (Final data collection date for primary outcome measure)
  • 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.

Change in dietary self-efficacy from baseline [ Time Frame: Baseline to 6 months (measured monthly) and to 12 months ]
Self efficacy is defined as an individual's belief and confidence in his or her own ability to make a behavior change.
Complete list of historical versions of study NCT01246349 on ClinicalTrials.gov Archive Site
  • Physiological Outcomes: BMI [ Time Frame: Baseline, 6 month follow-up ]
    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.
  • Physiological Outcomes: Waist Circumference [ Time Frame: Baseline, 6 month follow-up ]
    Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.
  • Psychological Well-being [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ]
    Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)
  • Physiological outcomes [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ]

    The study will use a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight will be measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age will be determined with the use of an age appropriate growth curve chart.

    The Weight Loss Behavior Scale (WLBS; Smith, Williamson, Womble, Johnson, & Burke, 2000) is a 35-item questionnaire designed to be a brief measure of changes in eating and exercise habits over the course of weight loss treatment.

  • Psychological Well-being [ Time Frame: Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment ]
    Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)
Not Provided
Not Provided
 
Motivational Interviewing for Weight Loss
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Childhood Obesity
  • Behavioral: 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.
  • Behavioral: 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).
  • Experimental: Motivational Interviewing 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.
    Intervention: Behavioral: Motivational Interviewing (Treatment Group)
  • Active Comparator: Control Group
    The comparison group received six social skills training sessions instead of Motivational Interviewing (MI).
    Intervention: Behavioral: Social Skills Training (Control Group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01246349
1000017625
No
Not Provided
Not Provided
Jill Hamilton, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Jill Hamilton, MD The Hospital for Sick Children
The Hospital for Sick Children
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP