NCT01240499

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

3 years

First QC Date

November 9, 2010

Last Update Submit

October 5, 2011

Conditions

Keywords

Weight managementNew weight paradigmOverweight womenEating behaviorsAppetite ratingsBlood lipids

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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).

Study Arms (3)

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

Interventions

1. 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.

Also known as: Non applicable
Health-At-Every-Size (HAES)Social Support (SS)

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INAF, Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

OverweightFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Simone Lemieux, Ph.D., Dt.P.

    Department of food sciences and nutrition/Institute of Nutraceuticals and Functional Foods (INAF), Laval University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 15, 2010

Study Start

September 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2008

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations