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CompletedNCT03066531MOTIVOB-ACTUpdated Feb 26, 2024

MOTIVOB-(Acceptance and Commitment Therapy Group Intervention for Obesity)Section

An interventional study of ACT-based intervention and CBT-based intervention in Obesity, sponsored by Istituto Auxologico Italiano. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2014, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

The purpose of the present study is to compare an Acceptance and Commitment Therapy (ACT) group intervention and a Cognitive Behavioral Therapy (CBT) group in a sample of obese individuals with respect to mid-term outcome.

Read the detailed description

Effective weight-management programs often include a combination of physical activity, diet, and psychological intervention, in particular Cognitive Behavioral Therapy (CBT). The effects of these programs are frequently not stable, and usually the maintenance of achieved weight-loss lasts only for a short period of time. Acceptance and Commitment Therapy, ACT, keeps on gaining recognition in obesity treatment. The purpose of the study is to compare weight loss and indicator of psychological functioning in a population of obese subjects belonging to three different diagnostic categories: without ED, with ED NAS and with BED. Participants were exposed respectively to a CBT or an ACT treatment and were assessed three times: pre intervention, post intervention and follow-up. The investigators hypothesize that CBT and ACT are both effective in the post-intervention. ACT intervention should be more effective in the follow-up both for weight and psychological functioning, due to its focus on the flexible managing of the global context instead of the focus on the pathology itself, more typical in standard CBT treatment.

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Conditions studied

  • Obesity

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Keywords

  • ACT
  • CBT obesity
  • Eating disorders
  • Health psychology
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 156 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. between the ages of 18 and 70 years
  2. obesity according to the WHO criteria (BMI ≥ 30)
  3. fluency in spoken and written Italian language
  4. expression of written informed consent

Exclusion criteria

Exclusion Criteria:

  1. other severe psychiatric disturbance different form eating disorders diagnosed by DSM-5 criteria (SCID-Structured Clinical Interview for DSM-IV-TR Disorders I and II and DSM 5 manual, administered by an independent clinical psychologist, were used as screening tools for psychiatric disorders)
  2. concurrent severe medical condition not related to obesity
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
156 participants (actual)

Study arms

  • Experimental
    ACT-based intervention

    The ACT-based intervention integrates educational topics on heart healthy behaviours with mindfulness and acceptance training regarding difficult thoughts and feelings, clarification of health-related values and commitment to behave in the valued direction while contacting difficult experiences.

    Behavioral: ACT-based intervention

  • Active comparator
    CBT-based intervention included in Usual Care

    These programs are based on current guidelines for the long- term multi-disciplinary rehabilitation and prevention of obese patients, including Cognitive Behavioral Therapy (CBT), in a group setting, as Gold Standard. Assigned Interventions: Behavioral: usual care (CBT)

    Behavioral: CBT-based intervention

Interventions

  • BehavioralACT-based intervention
  • BehavioralCBT-based intervention
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What researchers measure

Primary outcomes

  1. CORE-OM

    The change in the score of CORE-OM measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up. CORE-OM (Italian version by Palmieri et al., 2009) is a self-report measure designed for use as a baseline and outcome measure in psychological therapies and after its conclusion. It assesses the subjective experience of a person, as well as the way he or she functions in the world. It is composed by 34 items on a 5-points likert-scale from 0 (never) to 4 (always). Low scores correspond to high wellbeing. The CORE-OM provided 5 scales: wellness, symptoms, functioning, risk and total. The investigator involved in administering and interpreting the CORE-OM were blinded to treatment assignment.

    Time frame: Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

  2. AAQ-II

    The change in the score of AAQ-II measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up.The Acceptance and Action Questionnaire (AAQ; Hayes et al., 2004) is the most widely used measure of experiential avoidance and psychological inflexibility. We used the 7-item Italian (7-points likert-scale from 0-never true to 7-always true) version of AAQ-II (Pennato, Berrocal, Bernini \& Rivas, 2013) that shows adequate indexes of validity and reliability with a single-factor structure. In the case of AAQ-II higher scores indicate greater psychological flexibility.

    Time frame: Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

Secondary outcomes

  1. Weight

    The change in the weight, expressed in kilograms, measured in three time points, before treatment (baseline), post treatment (after one month in-patient rehabilitation program) and at 6 months Follow-Up.

    Time frame: Baseline - Post-Treatment (one month in-patient rehabilitation intervention) - FollowUp at 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504. PubMed 16443717 ↗
  • Juarascio AS, Forman EM, Herbert JD. Acceptance and commitment therapy versus cognitive therapy for the treatment of comorbid eating pathology. Behav Modif. 2010 Mar;34(2):175-90. doi: 10.1177/0145445510363472. PubMed 20308357 ↗
  • Cattivelli R, Pietrabissa G, Ceccarini M, Spatola CA, Villa V, Caretti A, Gatti A, Manzoni GM, Castelnuovo G. ACTonFOOD: opportunities of ACT to address food addiction. Front Psychol. 2015 Apr 9;6:396. doi: 10.3389/fpsyg.2015.00396. eCollection 2015. No abstract available. PubMed 25914662 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03066531
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Feb 28, 2017
Start date
Jan 1, 2014
Primary completion
Jan 1, 2016
Completion
Jan 1, 2016
Last update
Feb 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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