- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02453854
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
Intervention / Treatment
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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