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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Intervention s'Inspirant du Nouveau Paradigme en matière de Gestion de Poids Chez Des Femmes préménopausées présentant un Surplus de Poids

Conditions
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Overweight

Intervention / Treatment
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* Other: Health-At-Every-Size (HAES)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health-At-Every-Size (HAES)<br> | Other: Health-At-Every-Size (HAES)<br>* 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.<br>* Other names: Non applicable;|
| Active Comparator: Social Support (SS)<br> | Other: Health-At-Every-Size (HAES)<br>* 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.<br>* Other names: Non applicable;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight management, New weight paradigm, Overweight women, Eating behaviors, Appetite ratings, Blood lipids