Small Changes a One Year Protocol for Weight Management

May 21, 2015 updated by: Trevor Simper, Small Changes

Study Protocol: Small Changes, a One-year Weight Management Intervention for Adults Who Are Overweight or Obese

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

Study Overview

Status

Completed

Conditions

Detailed Description

A quasi-experimental design. With one arm focussed on 'treatment as usual' and the other on Motivational Interviewing. Subjects were not randomly assigned but treated as two separate cohorts one Running October 2011-October 2012 using the Treatment as usual and a separate cohort running from October 2012 to October -2013 using motivational interviewing as the approach for treatment.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass index equal to or greater than 30 kgm2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as Usual
A Treatment as Usual (TAU) group received a psycho-educational programme for weight management over one year
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.
Experimental: Group Motivational Intervieiwng
A Motivational interviewing group received one year of programme using motivational interviewing as the approach for treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 1 year
Bodyweight in Kilograms
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • smallchanges2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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