Dissemination of the "Choisir de Maigrir?" Program

Obesity Clinical Trial

— CHOIX-CSSS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640821
• Other study ID #: MP-ASSS-MTL-10-001
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: September 11, 2013
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functionnal Foods (INAF)	Québec city	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to one year post-intervention	No
Secondary	Eating behaviors	To evaluate the impact of the CdM? program on eating behaviors.	Up to one year post-intervention	No
Secondary	Physical activity	To evaluate the impact of the CdM? program on physical activity.	Up to one year post-intervention	No
Secondary	Well-being	To evaluate the impact of the CdM? program on well-being.	Up to one year post-intervention	No
Secondary	Weight	To evaluate the impact of the CdM? program on weight.	Up to one year post-intervention	No