OverweightCHOIXNCT01240499
Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women
A study testing Health-At-Every-Size (HAES) in people with Overweight, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Health-At-Every-Size (HAES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids
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.
Read the 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).
- Conditions
- Overweight
- Being tested
- Health-At-Every-Size (HAES)
- Keywords
- Weight management, New weight paradigm, Overweight women, Eating behaviors, Appetite ratings, Blood lipids
- Medical subject headings
- Overweight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-At-Every-Size (HAES)Other
Also called Non applicable
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Health-At-Every-Size (HAES) | Experimental | Not described Receives: Other: Health-At-Every-Size (HAES) |
| Social Support (SS) | Active comparator | Not described Receives: Other: Health-At-Every-Size (HAES) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startSep 2003
- Primary completionSep 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Simone Lemieux, Laval University
- Investigators
- Simone Lemieux, Ph.D., Dt.P., Principal investigator, Department of food sciences and nutrition/Institute of Nutraceuticals and Functional Foods (INAF), Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240499
- Sponsor's protocol ID
- CHOIX-170
- Acronym
- CHOIX
- Status last verified
- Oct 2011
- First submitted
- 9 Nov 2010
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20851157Gagnon-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.
PubMed 20798861Provencher 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.
PubMed 19857626Gagnon-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.
PubMed 19034910Provencher 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.
PubMed 18549988Provencher 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.
PubMed 17549091Provencher 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.
PubMed 17426331Leblanc 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.
PubMed 22296874
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids
- ClinicalTrials.gov ID
- NCT01240499
- Acronym / sponsor ID
- CHOIX / CHOIX-170
- Conditions
- Overweight
- Keywords
- Weight management, New weight paradigm, Overweight women, Eating behaviors, Appetite ratings, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health-At-Every-Size (HAES) | Experimental | Other: Health-At-Every-Size (HAES) |
| Social Support (SS) | Active comparator | Other: Health-At-Every-Size (HAES) |
| Control | No intervention | – |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-At-Every-Size (HAES)Also: Non applicable1. 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. 2. 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. | Other | Health-At-Every-Size (HAES), Social Support (SS) |
Primary outcome
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.
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).
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.
1 secondary outcome
Anthropometric and metabolic variables
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Results publication: PubMed 20851157Gagnon-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 publication: PubMed 20798861Gagnon-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 publication: PubMed 19857626Provencher 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 publication: PubMed 19034910Gagnon-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 publication: PubMed 18549988Provencher 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 publication: PubMed 17549091Provencher 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 publication: PubMed 17426331Provencher 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.
- Derived from this study: PubMed 22296874Leblanc 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Lemieux, Ph.D., Dt.P. principal investigator
Department of food sciences and nutrition/Institute of Nutraceuticals and Functional Foods (INAF), Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-At-Every-Size (HAES) in people with Overweight, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240499, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.