- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640821
Dissemination of the "Choisir de Maigrir?" Program (CHOIX-CSSS)
September 11, 2013 updated by: Véronique Provencher, Laval University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
328
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Québec city, Quebec, Canada, G1V 0A6
- Institute of Nutraceuticals and Functionnal Foods (INAF)
-
-
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
Female
Description
Inclusion Criteria:
- Women
- 18 years old and over
- Seeking help for weight-related problems
Exclusion Criteria:
- 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.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group (CdM?)
This group will be composed of women that are seeking help for weight-related problems that have been referred to the CdM? program.
|
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.
|
NO_INTERVENTION: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to one year post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating behaviors
Time Frame: Up to one year post-intervention
|
To evaluate the impact of the CdM? program on eating behaviors.
|
Up to one year post-intervention
|
Physical activity
Time Frame: Up to one year post-intervention
|
To evaluate the impact of the CdM? program on physical activity.
|
Up to one year post-intervention
|
Well-being
Time Frame: Up to one year post-intervention
|
To evaluate the impact of the CdM? program on well-being.
|
Up to one year post-intervention
|
Weight
Time Frame: Up to one year post-intervention
|
To evaluate the impact of the CdM? program on weight.
|
Up to one year post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
September 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
July 13, 2012
First Posted (ESTIMATE)
July 16, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 12, 2013
Last Update Submitted That Met QC Criteria
September 11, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MP-ASSS-MTL-10-001
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on CdM? program
-
Mahidol UniversityUniversity of Medical Technology, YangonCompletedCognitive ChangeMyanmar
-
Edward Ellerbeck, MD, MPHNational Cancer Institute (NCI)Completed
-
Qure Healthcare, LLCCompletedCardiometabolic SyndromeUnited States
-
Washington University School of MedicineSociety of Family PlanningCompletedContraception | Satisfaction | Decision Making | Evaluation
-
Research Unit for General Practice in AalborgRecruitingCommunity-acquired PneumoniaDenmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
National Yang Ming Chiao Tung UniversityNot yet recruitingBreast Cancer | Weight LossTaiwan
-
National Taiwan University HospitalCompleted
-
University of Maryland, BaltimoreNational Institute of Nursing Research (NINR)CompletedOsteoporosis | Health Behaviors
-
University of Illinois at ChicagoRecruitingMultiple Sclerosis | Cognitive Impairment | Older Adults | Walking ImpairmentUnited States