NCT01640821

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

July 12, 2012

Last Update Submit

September 11, 2013

Conditions

Keywords

Health-At-Every-Size intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Eating behaviors

    Up to one year post-intervention

  • Physical activity

    Up to one year post-intervention

  • Well-being

    Up to one year post-intervention

  • Weight

    Up to one year post-intervention

Study Arms (2)

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.

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.

Interventions

CdM? programBEHAVIORAL

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.

Intervention group (CdM?)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • years old and over
  • Seeking help for weight-related problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutraceuticals and Functionnal Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Véronique Provencher, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur sous octroi

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations