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Promotion of Exercise and Health in Obesity (PESO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Technical University of Lisbon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Technical University of Lisbon
ClinicalTrials.gov Identifier:
NCT00513084
First received: August 7, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

August 7, 2007
August 7, 2007
July 2004
Not Provided
Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA [ Time Frame: baseline, 4, 12, 16, 24 and 36 months ]
Same as current
No Changes Posted
Dietary Intake, psychosocial SDT-based mediators [ Time Frame: baseline, 4, 12,16, 24 and 36 months ]
Same as current
Not Provided
Not Provided
 
Promotion of Exercise and Health in Obesity
Moderators and Mediators of Physical Activity, Body Weight, and Body Composition Change During Obesity Treatment in Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
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.
Other Name: GI: Intervention Group
  • Experimental: SDT Intervention
    This arm will follow main experimental intervention, as described elsewhere
    Intervention: Behavioral: SDT and Motivational Interviewing in Obesity Treatment
  • No Intervention: Comparison Group
    Comparison Group receiving standard care health promotion intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
259
July 2009
Not Provided

Inclusion Criteria:

  • female (25-50 years old)
  • pre-menopausal
  • BMI between 25 and 40 kg/m2
  • willing to attend weekly meetings (during 1 year)
  • willing to not participate in other formal or informal weight loss program during the first year of the study (intervention group only).

Exclusion Criteria:

  • major/chronic illness
  • taking (or having taken in the previous year) medication known to interfere with body weight regulation, including anti-depressive medication
Female
25 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00513084
FCT-POCI/DES/57705/2004
No
Not Provided
Technical University of Lisbon
Not Provided
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
Technical University of Lisbon
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP