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Promotion of Exercise and Health in Obesity

NCT ID: NCT00513084

Last Updated: 2007-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SDT Intervention

This arm will follow main experimental intervention, as described elsewhere

Group Type EXPERIMENTAL

SDT and Motivational Interviewing in Obesity Treatment

Intervention Type BEHAVIORAL

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.

Comparison Group

Comparison Group receiving standard care health promotion intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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GI: Intervention Group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Lisbon

OTHER

Sponsor Role lead

Principal Investigators

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Pedro J Teixeira, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Human Movement, Technical University of Lisbon

Luis B Sardinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Human Movement, Technical University of Lisbon

Locations

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Faculty of Human Movement, Technical University of Lisbon

Lisbon, Estrada Da Costa, Portugal

Site Status

Countries

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Portugal

References

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Minderico CS, Silva AM, Fields DA, Branco TL, Martins SS, Teixeira PJ, Sardinha LB. Changes in thoracic gas volume with air-displacement plethysmography after a weight loss program in overweight and obese women. Eur J Clin Nutr. 2008 Mar;62(3):444-50. doi: 10.1038/sj.ejcn.1602709. Epub 2007 Mar 28.

Reference Type RESULT
PMID: 17392701 (View on PubMed)

Teixeira PJ, Going SB, Houtkooper LB, Cussler EC, Metcalfe LL, Blew RM, Sardinha LB, Lohman TG. Exercise motivation, eating, and body image variables as predictors of weight control. Med Sci Sports Exerc. 2006 Jan;38(1):179-88. doi: 10.1249/01.mss.0000180906.10445.8d.

Reference Type RESULT
PMID: 16394972 (View on PubMed)

Jorge R, Santos I, Tomas R, Silva MN, Carraca EV, Teixeira VH, Teixeira PJ. Behavioural and psychological pretreatment predictors of short- and long-term weight loss among women with overweight and obesity. Eat Weight Disord. 2020 Oct;25(5):1377-1385. doi: 10.1007/s40519-019-00775-9. Epub 2019 Sep 13.

Reference Type DERIVED
PMID: 31520301 (View on PubMed)

Carraca EV, Markland D, Silva MN, Coutinho SR, Vieira PN, Minderico CS, Sardinha LB, Teixeira PJ. Physical activity predicts changes in body image during obesity treatment in women. Med Sci Sports Exerc. 2012 Aug;44(8):1604-12. doi: 10.1249/MSS.0b013e31824d922a.

Reference Type DERIVED
PMID: 22330022 (View on PubMed)

Silva MN, Markland D, Carraca EV, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Exercise autonomous motivation predicts 3-yr weight loss in women. Med Sci Sports Exerc. 2011 Apr;43(4):728-37. doi: 10.1249/MSS.0b013e3181f3818f.

Reference Type DERIVED
PMID: 20689448 (View on PubMed)

Teixeira PJ, Silva MN, Coutinho SR, Palmeira AL, Mata J, Vieira PN, Carraca EV, Santos TC, Sardinha LB. Mediators of weight loss and weight loss maintenance in middle-aged women. Obesity (Silver Spring). 2010 Apr;18(4):725-35. doi: 10.1038/oby.2009.281. Epub 2009 Aug 20.

Reference Type DERIVED
PMID: 19696752 (View on PubMed)

Silva MN, Markland D, Minderico CS, Vieira PN, Castro MM, Coutinho SR, Santos TC, Matos MG, Sardinha LB, Teixeira PJ. A randomized controlled trial to evaluate self-determination theory for exercise adherence and weight control: rationale and intervention description. BMC Public Health. 2008 Jul 9;8:234. doi: 10.1186/1471-2458-8-234.

Reference Type DERIVED
PMID: 18613959 (View on PubMed)

Other Identifiers

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FCT-POCI/DES/57705/2004

Identifier Type: -

Identifier Source: org_study_id