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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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