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Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women (CHOIX)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health-At-Every-Size (HAES)
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Weight management, New weight paradigm, Overweight women, Eating behaviors, Appetite ratings, Blood lipids

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria:

  • Healthy premenopausal women from Quebec City metropolitan area
  • Age: between 30 to 50 years old
  • Stable body weight (+/- 2 kg) for at least 2 months before the beginning of the study
  • Overweight or obesity: Body mass index [BMI] between 25 and 35 kg/m2
  • Preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years)
  • Current weight corresponding to maximum weight reached during adult lifetime

Exclusion criteria:

  • Women currently dieting to lose weight
  • Taking oral contraceptives or postmenopausal status
  • Pregnant or lactating women
  • Under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease)
  • Women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, …)
  • Women who had already take part to the Health-At-Every-Size (HAES) approach

Sites / Locations

  • INAF, Laval University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Health-At-Every-Size (HAES)

Social Support (SS)

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in global health status outcomes (metabolic, psychological and nutritional variables, physical activity habits) from baseline to the end of the intervention, and at 6 and 12 months post-intervention.
Plasma LDL-cholesterol concentrations, Eating behaviors (restraint, disinhibition, and susceptibility to hunger), appetite ratings (desire to eat, hunger, fullness, and prospective food consumption), psychological variables (e.g. quality of life, self-esteem), physical activity habits, dietary intakes.

Secondary Outcome Measures

Anthropometric and metabolic variables
Anthropometric measures (body mass index, waist and hip circumferences) and metabolic variables (blood lipids, insulin and glucose levels, blood pressure, resting metabolic rate, salivary cortisol levels).

Full Information

First Posted
November 9, 2010
Last Updated
October 5, 2011
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01240499
Brief Title
Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women
Acronym
CHOIX
Official Title
Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts.
Detailed Description
Weight management is a critical issue in developed countries where the prevalence of obesity is increasing. Poor long-term success observed with current weight-control strategies stresses the relevance to explore new weight management approaches. One of these approaches, referred to as Health-At-Every-Size (HAES), is a new weight paradigm that focuses on a healthy lifestyle by promoting overall health benefits of behavioral changes related to dietary habits and physical activity and emphasizes self-acceptance and well-being, independently of body weight status. Studies on the effects of a HAES approach have shown significant improvements in metabolic and psychological variables. To our knowledge, no study has yet reported the short and long-term impacts of a HAES approach on a cluster of variables (psychological, morphological, metabolic, and nutritional) in women. The aim of this study is to measure the effects of a HAES approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts. In this parallel controlled trial, women will be randomized to one of the 3 treatment conditions: HAES group, Social support group (SS), or Control group. Measurements will be taken in the short term as well as in the long term (up to 1 year post-intervention).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Weight management, New weight paradigm, Overweight women, Eating behaviors, Appetite ratings, Blood lipids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health-At-Every-Size (HAES)
Arm Type
Experimental
Arm Title
Social Support (SS)
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Health-At-Every-Size (HAES)
Other Intervention Name(s)
Non applicable
Intervention Description
HAES group: 14 weekly sessions. Focus on general well-being and positive ways of having a healthy and satisfying lifestyle. Supported by lectures, guided self-reflection, group discussions, as well as practical exercises, this intervention aims at enhancing awareness and knowledge about biological, psychological, and sociocultural aspects of body weight. SS group: 14 weekly sessions. The objective is to reproduce a structural social support provided by the group itself. Each participant offers their support to each other. Each theme discussed in the HAES group is repeated in the SS group but the health professionals in charge of the group (dietitian & psychologist) are not counselors (as in HAES group) but only facilitators. Outcome measures: For all women under study.
Primary Outcome Measure Information:
Title
Change in global health status outcomes (metabolic, psychological and nutritional variables, physical activity habits) from baseline to the end of the intervention, and at 6 and 12 months post-intervention.
Description
Plasma LDL-cholesterol concentrations, Eating behaviors (restraint, disinhibition, and susceptibility to hunger), appetite ratings (desire to eat, hunger, fullness, and prospective food consumption), psychological variables (e.g. quality of life, self-esteem), physical activity habits, dietary intakes.
Time Frame
At baseline and at the end of the intervention period (4 months), and at 6 months and 1 year post-intervention (10 months and 16 months, respectively).
Secondary Outcome Measure Information:
Title
Anthropometric and metabolic variables
Description
Anthropometric measures (body mass index, waist and hip circumferences) and metabolic variables (blood lipids, insulin and glucose levels, blood pressure, resting metabolic rate, salivary cortisol levels).
Time Frame
At baseline and at the end of the intervention period (4 months), and at 6 months and 1 year post-intervention (10 months and 16 months, respectively).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy premenopausal women from Quebec City metropolitan area Age: between 30 to 50 years old Stable body weight (+/- 2 kg) for at least 2 months before the beginning of the study Overweight or obesity: Body mass index [BMI] between 25 and 35 kg/m2 Preoccupation about weight and eating: showing overconcern with shape and weight, exhibiting restriction over food choices for at least 2 years, and having been unsuccessful in previous attempts to lose weight (for at least the past 2 years) Current weight corresponding to maximum weight reached during adult lifetime Exclusion criteria: Women currently dieting to lose weight Taking oral contraceptives or postmenopausal status Pregnant or lactating women Under treatment for coronary heart disease, diabetes, dyslipidemia, hypertension, depression or endocrine disorders (with the exception of stable thyroid disease) Women presenting metabolic or important psychological disorders (drug or alcohol abuse, bulimia, …) Women who had already take part to the Health-At-Every-Size (HAES) approach
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Lemieux, Ph.D., Dt.P.
Organizational Affiliation
Department of food sciences and nutrition/Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
INAF, Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20851157
Citation
Gagnon-Girouard MP, Begin C, Provencher V, Tremblay A, Boivin S, Lemieux S. Subtyping weight-preoccupied overweight/obese women along restraint and negative affect. Appetite. 2010 Dec;55(3):742-5. doi: 10.1016/j.appet.2010.09.011. Epub 2010 Sep 17.
Results Reference
result
PubMed Identifier
20798861
Citation
Gagnon-Girouard MP, Begin C, Provencher V, Tremblay A, Mongeau L, Boivin S, Lemieux S. Psychological Impact of a "Health-at-Every-Size" Intervention on Weight-Preoccupied Overweight/Obese Women. J Obes. 2010;2010:928097. doi: 10.1155/2010/928097. Epub 2010 Jun 29.
Results Reference
result
PubMed Identifier
19857626
Citation
Provencher V, Begin C, Tremblay A, Mongeau L, Corneau L, Dodin S, Boivin S, Lemieux S. Health-At-Every-Size and eating behaviors: 1-year follow-up results of a size acceptance intervention. J Am Diet Assoc. 2009 Nov;109(11):1854-61. doi: 10.1016/j.jada.2009.08.017.
Results Reference
result
PubMed Identifier
19034910
Citation
Gagnon-Girouard MP, Begin C, Provencher V, Tremblay A, Boivin S, Lemieux S. Can we apply the dual-pathway model of overeating to a population of weight-preoccupied overweight women? Int J Eat Disord. 2009 Apr;42(3):244-52. doi: 10.1002/eat.20614.
Results Reference
result
PubMed Identifier
18549988
Citation
Provencher V, Begin C, Gagnon-Girouard MP, Tremblay A, Boivin S, Lemieux S. Personality traits in overweight and obese women: associations with BMI and eating behaviors. Eat Behav. 2008 Aug;9(3):294-302. doi: 10.1016/j.eatbeh.2007.10.004. Epub 2007 Nov 6.
Results Reference
result
PubMed Identifier
17549091
Citation
Provencher V, Begin C, Gagnon-Girouard MP, Gagnon HC, Tremblay A, Boivin S, Lemieux S. Defined weight expectations in overweight women: anthropometrical, psychological and eating behavioral correlates. Int J Obes (Lond). 2007 Nov;31(11):1731-8. doi: 10.1038/sj.ijo.0803656. Epub 2007 Jun 5.
Results Reference
result
PubMed Identifier
17426331
Citation
Provencher V, Begin C, Tremblay A, Mongeau L, Boivin S, Lemieux S. Short-term effects of a "health-at-every-size" approach on eating behaviors and appetite ratings. Obesity (Silver Spring). 2007 Apr;15(4):957-66. doi: 10.1038/oby.2007.638.
Results Reference
result
PubMed Identifier
22296874
Citation
Leblanc V, Provencher V, Begin C, Corneau L, Tremblay A, Lemieux S. Impact of a Health-At-Every-Size intervention on changes in dietary intakes and eating patterns in premenopausal overweight women: results of a randomized trial. Clin Nutr. 2012 Aug;31(4):481-8. doi: 10.1016/j.clnu.2011.12.013. Epub 2012 Jan 31.
Results Reference
derived

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Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women

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