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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Simone Lemieux, Laval University
ClinicalTrials.gov Identifier:
NCT01240499
First received: November 9, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Overweight
Other: Health-At-Every-Size (HAES)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids

Further study details as provided by Laval University:

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. [ 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). ] [ Designated as safety issue: No ]
    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 [ 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). ] [ Designated as safety issue: No ]
    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).


Enrollment: 144
Study Start Date: September 2003
Study Completion Date: September 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health-At-Every-Size (HAES) Other: Health-At-Every-Size (HAES)
  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.

Other Name: Non applicable
Active Comparator: Social Support (SS) Other: Health-At-Every-Size (HAES)
  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.

Other Name: Non applicable
No Intervention: Control

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).

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240499

Locations
Canada
INAF, Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Simone Lemieux, Ph.D., Dt.P. Department of food sciences and nutrition/Institute of Nutraceuticals and Functional Foods (INAF), Laval University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simone Lemieux, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT01240499     History of Changes
Other Study ID Numbers: CHOIX-170
Study First Received: November 9, 2010
Last Updated: October 5, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
Weight management
New weight paradigm
Overweight women
Eating behaviors
Appetite ratings
Blood lipids

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014