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Sponsored by: |
Technical University of Lisbon |
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Information provided by: | Technical University of Lisbon |
ClinicalTrials.gov Identifier: | NCT00513084 |
The primary objectives of this randomized clinical trial are a) to implement and test the impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on 3-year change in physical activity and motivation for exercise/physical activity, body weight and fat, and selected eating variables, b) to identify behavioral and psychosocial theory-based moderators or mediators of primary outcomes, especially physical activity and body weight.
Condition | Intervention |
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Obesity |
Behavioral: SDT and Motivational Interviewing in Obesity Treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Moderators and Mediators of Physical Activity, Body Weight, and Body Composition Change During Obesity Treatment in Women |
Enrollment: | 259 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2009 |
Arms | Assigned Interventions |
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SDT Intervention: Experimental
This arm will follow main experimental intervention, as described elsewhere
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Behavioral: SDT and Motivational Interviewing in Obesity Treatment
Thirty group sessions, designed to follow SDT, covering PA, eating/nutrition, body image, and other cognitive-behavioral contents. Central to the intervention are improving autonomy, intrinsic motivation, and self-regulation of behavior change. Accepting ambivalence for change, rolling with resistance, and developing discrepancy were used throughout the program, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control.
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Comparison Group: No Intervention
Comparison Group receiving standard care health promotion intervention
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Obesity and sedentary lifestyles are worldwide threats to public health but feasible and effective strategies to tackle these problems are scarce. The identification of variables that explain why only a sub-group of overweight persons succeeds at increasing physical activity and achieving long-term weight control is a key research topic in exercise and sports sciences. Subjects are 260 healthy women (BMI, 25 to 40 kg/m2), aged between 25 and 50 years, premenopausal, of whom half receive the treatment intervention, the remaining being randomly assigned to a control group at baseline. This RCT consists of a 1-year intervention plus a 2-year no contact follow-up period. The intervention group attended 30 weekly group sessions, designed to follow SDT basic tenets, covering PA, eating/nutrition, body image, and other cognitive and behavioral contents. Central to the intervention model are autonomy, intrinsic motivation, and self-regulation of behavior change. Autonomy-supportive treatment climate and internal causality orientations are predicted to enhance autonomous regulation, perceived competence, and intrinsic motivation for the targeted behaviors, resulting in lasting behavioral and body weight changes. The intervention was designed to follow SDT, with an emphasis on promoting intrinsic, self-regulated motivation for exercise and weight control. The control group received a general health education curriculum based on several 3- to 6-week long educational topics (e.g. food safety, stress management, self-care, body image, and others). Results are expected to contribute to a better understanding of how individual characteristics, particularly those related to physical activity and exercise influence success, better screening/readiness testing procedures, improved matching of interventions to participants, and lower rates of attrition and unsuccessful weight loss attempts.
Ages Eligible for Study: | 25 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Portugal, Estrada da Costa | |
Faculty of Human Movement, Technical University of Lisbon | |
Lisbon, Estrada da Costa, Portugal, 1495-688 Cruz-Quebrada |
Principal Investigator: | Pedro J Teixeira, PhD | Faculty of Human Movement, Technical University of Lisbon |
Principal Investigator: | Luis B Sardinha, PhD | Faculty of Human Movement, Technical University of Lisbon |
Study ID Numbers: | FCT-POCI/DES/57705/2004 |
Study First Received: | August 7, 2007 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00513084 |
Health Authority: | Portugal: Health Ethic Committee |
Behavioral, Self-Determination Theory, Motivational Interviewing, Exercise, Physical Activity, Motivation, |
Moderators, Mediators, Predictors, Weight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |