ObesityCHOIX-CSSSNCT01640821
Dissemination of the "Choisir de Maigrir?" Program
A study testing CdM? program in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence of overweight and obesity among young people and adults by 2012. One of the five priorities of the PAG is to improve health services for individuals with weight-related issues. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- CdM? program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Jun 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- 18 years old and over
- Seeking help for weight-related problems
Who cannot join
- Considering the natural setting of the present study and the fact that the program is occurring outside of the applicants' control, no stringent exclusion criteria will be determined.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functionnal Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
Official title: Dissemination of the "Choisir de Maigrir?" Program in Health and Social Service Centers in Québec: Evaluation of Its Implementation and Impact on Lifestyle Habits and Well-being
The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence of overweight and obesity among young people and adults by 2012. One of the five priorities of the PAG is to improve health services for individuals with weight-related issues. The development and implementation of sustainable weight-control strategies however remains a challenge, since weight loss is often regained by the majority of individuals over time. "Health-At-Every-Size" (HAES) interventions, which are mainly focusing on health rather that weight, have been proposed as an interesting alternative for individuals, mainly women, who are struggling with weight-related issues. Based on the HAES, "Choisir de maigrir?" (CdM?) program has been clearly identified by the PAG as one of the actions for improving health services and Quebec's government has already started a massive dissemination of the CdM? program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the effectiveness and readiness of the program for a broad dissemination. The present research proposal falls directly within the scope of the PAG recommendation and the investigators general objective is to develop a population-based understanding of the effectiveness of the CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in a natural setting.
Read the detailed description
The impact of "CdM?" will be assessed with each CSSS at three time points: at baseline (T=1), at the end of the intervention period (T=2), and at 1-y post-intervention (T=3). While data collection instructions and assessment materials will be provided by the research team, administration of the CdM? program will be totally under the responsibility of each CSSS, so that the program will occur outside of the research team control. Validated questionnaires will be used to assess nutritional profile, physical activity level, and psychosocial variables among the participants (N=168). Weight, height and waist circumference will also be measured for each participant. In order to ensure that our results are not due to the effect of time, women on a waiting list for CdM? program, will be recruited (N=84) for the short-term effect. All these data will be treated using sophisticated analyses strategies.
- Conditions
- Obesity
- Being tested
- CdM? program
- Keywords
- Health-At-Every-Size intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CdM? programBehavioural
The program is conducted in small groups of 12 to 15 women for 14 weekly sessions (13 3h-evening sessions and 1 intensive-day session of 6 hours). Two health professionals (a registered dietician and a social worker or psychologist) lead the group. Sessions include lectures, guided self-examination and observations, group discussions, and practical exercises. Different topics are discussed during sessions such as enjoyment of physical activity and healthy nutrition, setting realistic objectives with regard to weight loss, and acceptation of their own and others' body image. A weekly food diary and group discussions are used to facilitate the recognition of internal cues of hunger and satiety and the identification of external influences on eating behaviors and food intake.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (CdM?) | Experimental | This group will be composed of women that are seeking help for weight-related problems that have been referred to the CdM? program. Receives: Behavioral: CdM? program |
| Control group | No intervention | This group will be composed of women that are seeking help for weight-related problems but that are actually on the waiting list for participating to the CdM? program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food habits
To evaluate the impact of the CdM? program on food habits for all women will be conducted at three time points: at baseline (T=1), at the end of the intervention period (T=2), and at 1-y post-intervention (T=3).
Measured: Up to one year post-intervention
Secondary outcomes (4)
Eating behaviors
To evaluate the impact of the CdM? program on eating behaviors.
Measured: Up to one year post-intervention
Physical activity
To evaluate the impact of the CdM? program on physical activity.
Measured: Up to one year post-intervention
Well-being
To evaluate the impact of the CdM? program on well-being.
Measured: Up to one year post-intervention
Weight
To evaluate the impact of the CdM? program on weight.
Measured: Up to one year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionJun 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.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Véronique Provencher, Laval University
- Investigators
- Véronique Provencher, Ph.D., Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640821
- Sponsor's protocol ID
- MP-ASSS-MTL-10-001
- Acronym
- CHOIX-CSSS
- Status last verified
- Sep 2013
- First submitted
- 12 Jul 2012
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of the "Choisir de Maigrir?" Program in Health and Social Service Centers in Québec: Evaluation of Its Implementation and Impact on Lifestyle Habits and Well-being
- ClinicalTrials.gov ID
- NCT01640821
- Acronym / sponsor ID
- CHOIX-CSSS / MP-ASSS-MTL-10-001
- Conditions
- Obesity
- Keywords
- Health-At-Every-Size intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jul 2012 (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.
The Québec government launched in October 2006 an action plan (PAG) to reduce the prevalence of overweight and obesity among young people and adults by 2012. One of the five priorities of the PAG is to improve health services for individuals with weight-related issues. The development and implementation of sustainable weight-control strategies however remains a challenge, since weight loss is often regained by the majority of individuals over time. "Health-At-Every-Size" (HAES) interventions, which are mainly focusing on health rather that weight, have been proposed as an interesting alternative for individuals, mainly women, who are struggling with weight-related issues. Based on the HAES, "Choisir de maigrir?" (CdM?) program has been clearly identified by the PAG as one of the actions for improving health services and Quebec's government has already started a massive dissemination of the CdM? program in CSSS of Québec. In that context, it becomes imperative to rapidly assess the effectiveness and readiness of the program for a broad dissemination. The present research proposal falls directly within the scope of the PAG recommendation and the investigators general objective is to develop a population-based understanding of the effectiveness of the CdM? program in Quebec's CSSS by documenting the effects of the program on women's health in a natural setting.
Detailed description
The impact of "CdM?" will be assessed with each CSSS at three time points: at baseline (T=1), at the end of the intervention period (T=2), and at 1-y post-intervention (T=3). While data collection instructions and assessment materials will be provided by the research team, administration of the CdM? program will be totally under the responsibility of each CSSS, so that the program will occur outside of the research team control. Validated questionnaires will be used to assess nutritional profile, physical activity level, and psychosocial variables among the participants (N=168). Weight, height and waist circumference will also be measured for each participant. In order to ensure that our results are not due to the effect of time, women on a waiting list for CdM? program, will be recruited (N=84) for the short-term effect. All these data will be treated using sophisticated analyses strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (CdM?) | Experimental | Behavioral: CdM? programThis group will be composed of women that are seeking help for weight-related problems that have been referred to the CdM? program. |
| Control group | No intervention | –This group will be composed of women that are seeking help for weight-related problems but that are actually on the waiting list for participating to the CdM? program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women
- 18 years old and over
- Seeking help for weight-related problems
Key exclusion criteria (1 listed)
- Considering the natural setting of the present study and the fact that the program is occurring outside of the applicants' control, no stringent exclusion criteria will be determined.
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 |
|---|---|---|
| CdM? programThe program is conducted in small groups of 12 to 15 women for 14 weekly sessions (13 3h-evening sessions and 1 intensive-day session of 6 hours). Two health professionals (a registered dietician and a social worker or psychologist) lead the group. Sessions include lectures, guided self-examination and observations, group discussions, and practical exercises. Different topics are discussed during sessions such as enjoyment of physical activity and healthy nutrition, setting realistic objectives with regard to weight loss, and acceptation of their own and others' body image. A weekly food diary and group discussions are used to facilitate the recognition of internal cues of hunger and satiety and the identification of external influences on eating behaviors and food intake. | Behavioural | Intervention group (CdM?) |
Primary outcome
Food habits
Time frame: Up to one year post-intervention
To evaluate the impact of the CdM? program on food habits for all women will be conducted at three time points: at baseline (T=1), at the end of the intervention period (T=2), and at 1-y post-intervention (T=3).
4 secondary outcomes
Eating behaviors
Time frame: Up to one year post-intervention
Physical activity
Time frame: Up to one year post-intervention
Well-being
Time frame: Up to one year post-intervention
Weight
Time frame: Up to one year post-intervention
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 12 Sep 2013.
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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.
Véronique Provencher, Ph.D. principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CdM? program in people with Obesity, run by Laval University at 1 site in Canada.
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 3 inclusion and 1 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 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Food habits (time frame: Up to one year post-intervention). 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 12 Sep 2013.