Clinical trial NCT02649634: Does Motivational Interviewing Improve Behavioral Weight Loss Outcomes for Obesity?
Official title: Adding Motivational Interviewing to a Behavioral Weight Loss Treatment for Obesity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Motivational Interviewing
Obesity
Weight Loss
Behavioral Medicine
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adding motivational interviewing (MI) to a behavioural weight loss program (BWLP) results in improved weight loss for adults who are overweight or obese.

Detailed description: Although behavioural weight loss programs (BWLP) are typically the first line of treatment for obesity, they are often plagued by high attrition rates and poor adherence. Studies evaluating the benefit of adding motivational interviewing (MI) to BWLPs have yielded mixed findings. The main purpose of this randomized controlled trial was to assess the efficacy of adding MI to a BWLP on weight loss and adherence outcomes among 135 overweight and obese individuals enrolled in a 12-week (24 session) BWLP.

This study used a randomized, controlled, longitudinal, between-subjects design to investigate the effects of a two-session MI intervention on weight loss in participants enrolled in a BWLP. Patients received either two 45-60 minute MI interventions or two 45-60 minute attention control interviews. The control group interview consisted of questions ascertaining weight history, diet history, dietary awareness and physical activity. Questions for the control group focused primarily on assessment of past behaviour whereas questions for the MI group focused on enhancing motivation by exploring and resolving ambivalence. Weight was measured at baseline, end of the BWLP, and 6 months following BWLP completion. Program adherence (measured as number of BWLP sessions attended out of 24) was assessed as a secondary dependent measure. Importance, readiness, and confidence for weight change were assessed at baseline and then immediately following each interview (either MI or control). In addition, several other secondary outcome measures were assessed at baseline, end of the BWLP, 1 month follow-up, and 6 month follow-up.

Research personnel informed all BWLP participants about the study at the initial BWLP group intake assessments, which occurred just prior to the commencement of the formal BWLP. Individuals who expressed interest in participating were contacted by phone by a research assistant and screened for eligibility. If eligible, an appointment was made for the first MI/control session which was scheduled within the first two weeks of the BWLP. Randomization occurred immediately prior to this interview. Participants were then contacted during the 10th week of the BWLP to schedule a second MI/control session, which occurred approximately during the 12th week of the program. Participants were all contacted several weeks following program completion to schedule the one-month follow-up assessment. Finally, all participants were contacted approximately five months following program completion in order to schedule the six-month follow-up assessment.

Sessions were tape recorded for all participants for quality assurance purposes. A subset of tapes were used to assess for treatment integrity.

Eligibility criteria: Inclusion Criteria:

* Overweight to obese (BMI greater than or equal to 25 kilograms per meter squared).

Exclusion Criteria:

* Pregnancy (or intention of becoming pregnant within 9 months)
* Health issues that would preclude participation in physical activity
* Concurrent involvement in another weight loss program.

Primary outcomes:
measure: Weight at End of Behavioural Weight Loss Program, 12 Weeks
timeFrame: Mean weight recorded at the end of the behavioural weight loss program (week 12)
Secondary outcomes:
measure: Weight at 6 Month Follow up
timeFrame: Mean weight 6 months after the end of the behavioural weight loss program
measure: Adherence
timeFrame: Assessed once at the end of the behavioural weight loss program (week 12)
measure: BMI at End of Behavioural Weight Loss Program, Week 12
timeFrame: Mean BMI at the end of the behavioural weight loss program (week 12)
measure: BMI at 6 Month Follow up
timeFrame: Mean BMI 6 months after the end of the behavioural weight loss program
measure: Physical Activity at End of the Behavioural Weight Loss Program, Week 12
timeFrame: Mean physical activity as measured by the PPAQ, at the end of the behavioural weight loss program (week 12)
measure: Physical Activity at 1 Month Follow up
timeFrame: Mean physical activity as measured by the PPAQ, 1 month after the end of the behavioural weight loss program
measure: Physical Activity at 6 Month Follow up
timeFrame: Mean physical activity as measured by the PPAQ, 6 months after the end of the behavioural weight loss program
measure: Dietary Behaviour at End of the Behavioural Weight Loss Program, Week 12
timeFrame: Mean dietary behaviour score as measured by the overall DHQ score, at the end of the behavioural weight loss program (week 12)
measure: Dietary Behaviour at 1 Month Follow up
timeFrame: Mean dietary behaviour score as measured by the overall DHQ score, 1 month after the end of the behavioural weight loss program
measure: Dietary Behaviour at 6 Month Follow up
timeFrame: Mean dietary behaviour score as measured by the overall DHQ score, 6 months after the end of the behavioural weight loss program
measure: Blood Pressure at End of the Behavioural Weight Loss Program, Week 12
timeFrame: Mean blood pressure at the end of the behavioural weight loss program (week 12)
measure: Blood Pressure at 6 Month Follow up
timeFrame: Mean blood pressure 6 months after the end of the behavioural weight loss program
measure: Eating Disorder Symptomology at End of the Behavioural Weight Loss Program, Week 12
timeFrame: Mean eating disorder symptomology as measured by the global EDE-Q score, at the end of the behavioural weight loss program (week 12)
measure: Eating Disorder Symptomology at 1 Month Follow up
timeFrame: Mean eating disorder symptomology as measured by the global EDE-Q score, 1 month after the end of the behavioural weight loss program
measure: Eating Disorder Symptomology at 6 Month Follow up
timeFrame: Mean eating disorder symptomology as measured by the global EDE-Q score, 6 months after the end of the behavioural weight loss program
measure: Self-efficacy Related to Eating Patterns After the First Motivational Interviewing or Attention Control Interview, Week 1 - 2
timeFrame: Mean self-efficacy related to eating patterns measured immediately after the first MI or attention control interview (week 1 to 2)
measure: Self-efficacy for Engaging in Physical Activity After the First Motivational Interviewing or Attention Control Interview, Week 1- 2
timeFrame: Mean self-efficacy for engaging in physical activity measured immediately after the first MI or attention control interview (week 1 - 2)
measure: Self-efficacy Related to Eating Patterns After the Second Motivational Interviewing or Attention Control Interview, Week 12
timeFrame: Mean self-efficacy related to eating patterns measured immediately after the second MI or attention control interview (week 12)
measure: Self-efficacy for Engaging in Physical Activity After the Second Motivational Interviewing or Attention Control Interview, Week 12
timeFrame: Mean self-efficacy for engaging in physical activity measured immediately after the second MI or attention control interview (week 12)
measure: Importance of Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 - 2
timeFrame: Importance of change ratings measured immediately after the first MI or attention control interview (week 1- 2)
measure: Readiness for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 -2
timeFrame: Readiness for change ratings measured immediately after the first MI or attention control interview (week 1- 2)
measure: Confidence for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1- 2
timeFrame: Confidence for change ratings measured immediately after the first MI or attention control interview (week 1- 2)
measure: Importance for Change Ratings After the Second Motivational Interview or Attention Control Interview, Week 12
timeFrame: Importance of change ratings measured immediately after the second MI or attention control interview (week 12)
measure: Readiness for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12
timeFrame: Readiness for change ratings measured immediately after the second MI or attention control interview (week 12)
measure: Confidence for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12
timeFrame: Confidence for change ratings measured immediately after the second MI or attention control interview (week 12)
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Kristin M von Ranson, PhD
role: PRINCIPAL_INVESTIGATOR
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