NCT02453854

Brief Summary

A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2011

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

May 18, 2015

Last Update Submit

May 21, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • weight

    Bodyweight in Kilograms

    1 year

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

A Treatment as Usual (TAU) group received a psycho-educational programme for weight management over one year

Behavioral: Group motivational interviewing

Group Motivational Intervieiwng

EXPERIMENTAL

A Motivational interviewing group received one year of programme using motivational interviewing as the approach for treatment.

Behavioral: Group motivational interviewing

Interventions

Group motivational interviewingBEHAVIORAL

Monthly group meetings were held for two hour sessions each month and verifiable (treatment fidelity checked) motivational interviewing employed in helping clients make health behaviour changes.

Group Motivational IntervieiwngTreatment as Usual

Eligibility Criteria

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

You may qualify if:

  • Body Mass index equal to or greater than 30 kgm2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Trevor Simper

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 27, 2015

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05