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ObesityPESONCT00513084

Promotion of Exercise and Health in Obesity

A study testing SDT and Motivational Interviewing in Obesity Treatment in people with Obesity, run by Technical University of Lisbon at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 25 to 50 years, women only
Conditions the study is for
Obesity
What is being tested?
SDT and Motivational Interviewing in Obesity Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
1 sitePortugal
Study dates
Jul 2004to Jul 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • major/chronic illness
  • taking (or having taken in the previous year) medication known to interfere with body weight regulation, including anti-depressive medication

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Faculty of Human Movement, Technical University of Lisbon

    Lisbon, Estrada Da Costa, 1495-688 Cruz-Quebrada

Other trials in Portugal

About this study

Official title: 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.

Read the detailed description

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
Obesity
Being tested
SDT and Motivational Interviewing in Obesity Treatment
Keywords
Behavioral,, Self-Determination Theory,, Motivational Interviewing,, Exercise, Physical Activity,, Motivation,, Moderators,, Mediators,, Predictors,, Weight
Medical subject headings
Obesity, Behavior, Motor Activity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDT and Motivational Interviewing in Obesity TreatmentBehavioural

    Also called GI: Intervention Group

    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.

Study groups in NCT00513084
Study groupRoleWhat they receive
SDT InterventionExperimentalThis arm will follow main experimental intervention, as described elsewhere
Receives: Behavioral: SDT and Motivational Interviewing in Obesity Treatment
Comparison GroupNo interventionComparison Group receiving standard care health promotion intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, 4, 12, 16, 24 and 36 months

Secondary outcomes (1)

  1. Dietary Intake, psychosocial SDT-based mediators

    Measured: baseline, 4, 12,16, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2007 (estimated)
  2. Study startJul 2004
  3. Study completionJul 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513084
Sponsor's protocol ID
FCT-POCI/DES/57705/2004
Acronym
PESO
Status last verified
Jul 2007
First submitted
7 Aug 2007
Last updated
8 Aug 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17392701

  • 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.

    PubMed 16394972

  • 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.

    PubMed 31520301

  • 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.

    PubMed 22330022

  • 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.

    PubMed 20689448

  • 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.

    PubMed 19696752

  • 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.

    PubMed 18613959

Questions about this trial

What is this clinical trial studying?

A study testing SDT and Motivational Interviewing in Obesity Treatment in people with Obesity, run by Technical University of Lisbon at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00513084, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2007.

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