NCT02649634

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 20, 2017

Completed
Last Updated

March 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

January 5, 2016

Results QC Date

August 3, 2016

Last Update Submit

January 27, 2017

Conditions

ObesityOverweight

Keywords

Motivational InterviewingObesityWeight LossBehavioral Medicine

Outcome Measures

Primary Outcomes (1)

  • Weight at End of Behavioural Weight Loss Program, 12 Weeks

    Weight was measured to the nearest 0.1 kg using a balance beam scale

    Mean weight recorded at the end of the behavioural weight loss program (week 12)

Secondary Outcomes (25)

  • Weight at 6 Month Follow up

    Mean weight 6 months after the end of the behavioural weight loss program

  • Adherence

    Assessed once at the end of the behavioural weight loss program (week 12)

  • BMI at End of Behavioural Weight Loss Program, Week 12

    Mean BMI at the end of the behavioural weight loss program (week 12)

  • BMI at 6 Month Follow up

    Mean BMI 6 months after the end of the behavioural weight loss program

  • Physical Activity at End of the Behavioural Weight Loss Program, Week 12

    Mean physical activity as measured by the PPAQ, at the end of the behavioural weight loss program (week 12)

  • +20 more secondary outcomes

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Two 45-60 minute motivational interviewing sessions focusing on exploring and resolving ambivalence towards change.

Behavioral: Motivational Interviewing

Attention Control

ACTIVE COMPARATOR

Two 45-60 minute semi-structured interviews, acting as a pseudo-intervention, ascertaining information relevant to health history, weight history, diet history, as well as dietary and physical activity habits.

Behavioral: Attention Control

Interventions

Motivational InterviewingBEHAVIORAL

The semi-structured MI protocol was a 45-60 minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components.

Motivational Interviewing
Attention ControlBEHAVIORAL

The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues).

Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Armstrong MJ, Mottershead TA, Ronksley PE, Sigal RJ, Campbell TS, Hemmelgarn BR. Motivational interviewing to improve weight loss in overweight and/or obese patients: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2011 Sep;12(9):709-23. doi: 10.1111/j.1467-789X.2011.00892.x. Epub 2011 Jun 21.

    PMID: 21692966BACKGROUND

  • West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care. 2007 May;30(5):1081-7. doi: 10.2337/dc06-1966. Epub 2007 Mar 2.

    PMID: 17337504BACKGROUND

  • DiMarco ID, Klein DA, Clark VL, Wilson GT. The use of motivational interviewing techniques to enhance the efficacy of guided self-help behavioral weight loss treatment. Eat Behav. 2009 Apr;10(2):134-6. doi: 10.1016/j.eatbeh.2009.02.001. Epub 2009 Feb 15.

    PMID: 19447358BACKGROUND

  • Webber KH, Gabriele JM, Tate DF, Dignan MB. The effect of a motivational intervention on weight loss is moderated by level of baseline controlled motivation. Int J Behav Nutr Phys Act. 2010 Jan 22;7:4. doi: 10.1186/1479-5868-7-4.

    PMID: 20157441BACKGROUND

  • DiLillo V, Siegfried NJ, West DS. Incorporating motivational interviewing into behavioral obesity treatment. Cognitive and Behavioral Practice 10(2): 120-130, 2003.

    BACKGROUND

  • Hemmelgarn BR, McAlister FA, Grover S, Myers MG, McKay DW, Bolli P, Abbott C, Schiffrin EL, Honos G, Burgess E, Mann K, Wilson T, Penner B, Tremblay G, Milot A, Chockalingam A, Touyz RM, Tobe SW; Canadian Hypertension Education Program. The 2006 Canadian Hypertension Education Program recommendations for the management of hypertension: Part I--Blood pressure measurement, diagnosis and assessment of risk. Can J Cardiol. 2006 May 15;22(7):573-81. doi: 10.1016/s0828-282x(06)70279-3.

    PMID: 16755312BACKGROUND

  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PMID: 7866415BACKGROUND

  • Paffenbarger RS Jr, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in college alumni. Am J Epidemiol. 1978 Sep;108(3):161-75. doi: 10.1093/oxfordjournals.aje.a112608.

    PMID: 707484BACKGROUND

  • Kristal AR, Shattuck AL, Henry HJ. Patterns of dietary behavior associated with selecting diets low in fat: reliability and validity of a behavioral approach to dietary assessment. J Am Diet Assoc. 1990 Feb;90(2):214-20.

    PMID: 2303658BACKGROUND

  • Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.

    PMID: 1955608BACKGROUND

  • Moss EL, Tobin LN, Campbell TS, von Ranson KM. Behavioral weight-loss treatment plus motivational interviewing versus attention control: lessons learned from a randomized controlled trial. Trials. 2017 Jul 25;18(1):351. doi: 10.1186/s13063-017-2094-1.

    PMID: 28743313DERIVED

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Kristin von Ranson
Organization
University of Calgary
kvonrans@ucalgary.ca
403.220.7085

Study Officials

  • Kristin M von Ranson, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychology

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

September 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 20, 2017

Results First Posted

March 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Data uploaded to Zenodo.org