ObesityNCT02453854
Small Changes a One Year Protocol for Weight Management
A study testing Group motivational interviewing in people with Obesity, run by Small Changes.
Trial summary
A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Group motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass index equal to or greater than 30 kgm2
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Group motivational interviewing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | A Treatment as Usual (TAU) group received a psycho-educational programme for weight management over one year Receives: 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. Receives: Behavioral: Group motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
Bodyweight in Kilograms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Small Changes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Simper, Small Changes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453854
- Sponsor's protocol ID
- smallchanges2011
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol: Small Changes, a One-year Weight Management Intervention for Adults Who Are Overweight or Obese
- ClinicalTrials.gov ID
- NCT02453854
- Acronym / sponsor ID
- smallchanges2011
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Small ChangesUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Behavioral: Group motivational interviewingA Treatment as Usual (TAU) group received a psycho-educational programme for weight management over one year |
| Group Motivational Intervieiwng | Experimental | Behavioral: Group motivational interviewingA Motivational interviewing group received one year of programme using motivational interviewing as the approach for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass index equal to or greater than 30 kgm2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group motivational interviewingMonthly 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. | Behavioural | Group Motivational Intervieiwng, Treatment as Usual |
Primary outcome
weight
Time frame: 1 year
Bodyweight in Kilograms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group motivational interviewing in people with Obesity, run by Small Changes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.