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Trial record 1 of 1 for:    NCT03351712 | Italy
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mACTonHEALTH: Psychological Flexibility and Activity Tracker - Protocol (ACTonHEALTH)

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ClinicalTrials.gov Identifier: NCT03351712
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Castelnuovo, Istituto Auxologico Italiano

Brief Summary:
Obesity and overweight are growing steadily and becoming a global epidemic. Recent researches report a 64% of the adult population as overweight. The social and economical impact is increasing and the most of the rehabilitation programs, while effective in the short term, do not produce long lasting results. From a behavioral perspective an explanatory model can describe the phenomena with the lack of sources of reinforcement related to healthy habits in the daily-life context. The goal of this project, combining Acceptance and Commitment Therapy and Wearable Technology, is to develop an effective intervention, efficient and sustainable, which continues after ending of the hospitalization, providing adequate contingencies of reinforcement in the natural environment, integrating systematic measurements, continuous feedbacks and individualized, values-based objectives. Related goal-setting show a shift from results linked with weight loss towards action connected with healthy life-style.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: ACT-Based Intervention and Activity Tracker WITH Feedback Behavioral: Gold Standard Intervention + Activity Tracker WITHOUT Feedback Behavioral: Gold Standard Intervention and Activity Tracker WITH Feedback Behavioral: ACT-Based Intervention and Activity Tracker WITHOUT Feedback Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Single subject design and group design combined
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACTonHEALTH Study Protocol: Promoting Psychological Flexibility With Activity Tracker and mHealth Tools to Foster Healthy Lifestyle for Obesity and Other Chronic Health Conditions
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Gold Standard Intervention + Activity Tracker WITHOUT Feedback
Gold Standard Intervention + Activity Tracker WITHOUT Feedback (Medical Rehabilitation, Motivational Support and Psycho-Education) During the in-patient phase, participants will participate in the intensive four-week hospital-based and medically-managed rehabilitation program for weight reduction. All patients will be placed on a hypocaloric nutritionally balanced diet tailored to the individual after consultation with a dietitian. Furthermore, they will receive nutritional counseling provided by dietitians, have physical activity training provided by physiotherapists and motivational support with elements of psycho-education provided by physicians trained and informed by psychologists-psychotherapists.
Behavioral: Gold Standard Intervention + Activity Tracker WITHOUT Feedback
Medical Rehabilitation, Motivational Support and Psycho-Education

Experimental: Gold Standard Intervention and Activity Tracker WITH Feedback
In this experimental condition, will be provided the same rehabilitation program for the 4-weeks in-patient phase. In addition, for these subjects will be implemented a Stepped Protocol using wearable devices / activity trackers to collect information about daily physical activity and providing meaningful and informative feedbacks. The additional procedure starts during the in-patients phase, delivering and explaining the use of the wearable devices. In this meeting, longer than the one previously described for the control condition, experimenters provide information, set individualized goals and explain feedbacks which will be delivered after ending in-patients phase by the electronic wearable devices.
Behavioral: Gold Standard Intervention and Activity Tracker WITH Feedback
Behavioral Change Condition - Activity Tracker

Experimental: ACT-Based Intervention and Activity Tracker WITHOUT Feedback
In this experimental condition, the subjects followed the normal medical rehabilitation program described above for the first experimental condition. For the out-patient phase the ACT intervention includes monthly 30 minutes skype-telephone sessions. The ACT-based interventions includes different processes: 1) Acceptance, that involves the active awareness of difficult private experiences without attempts to control or avoid unpleasant emotions. 2) Mindfulness, refers to engaging in present moment experience and adopting an open and curious attitude. 3) Defusion: Participants will be encouraged to defuse from thoughts and feelings by turning attention toward the 'noticing-self', instead of becoming attached to thoughts and 'run' through life on 'auto-pilot'. 4) Values and Commitment: encouraging participants to live in accordance with their values, participants can engage in meaningful activities despite experiencing unwanted emotions/ sensations.
Behavioral: ACT-Based Intervention and Activity Tracker WITHOUT Feedback
ACT-Based Intervention Standalone

Experimental: ACT-Based Intervention and Activity Tracker WITH Feedback
ACT-Based Intervention and Activity Tracker WITH Feedback (Combining ACT and Behavioral Change) In the last experimental condition, obese individuals will follow the same rehabilitation program in the in-patients phase of the Behavioral Change condition, with the addition of the brief ACT intervention of 4 45-minutes sessions for a total amount of 3 hours one-to-one therapy sessions, exactly as in the ACT condition. In the out-patient phase of 16 weeks, each participant receive feedback from activity tracker following the same stepped protocol but message and feedbacks are informed by ACT therapist, including Value-based goal setting, prompt for including defusion from difficult thoughts, mindfulness cues and a set of ACT-consistent metaphors and messages.
Behavioral: ACT-Based Intervention and Activity Tracker WITH Feedback
Combining ACT and Behavioral Change




Primary Outcome Measures :
  1. Physical Activity directly measured by wearable devices Daily STEPS Count [ Time Frame: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up - ]
    Daily Steps directly collected by wearable devices


Secondary Outcome Measures :
  1. MDS - Mediterranean Diet Score [ Time Frame: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up - ]
    psychometric questionnaire about diet habits

  2. PGWBI - Psychological General Well-Being Index [ Time Frame: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up - ]
    psychometric questionnaire assessing well-being

  3. Acceptance & Action Questionnaire AAQ-II [ Time Frame: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up - ]
    psychometric questionnaire - a measure of Psychological Flexibility

  4. International Physical Activity Questionnaires (IPAQ-SF) [ Time Frame: Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up - ]
    Psychometric questionnaire that assesses Physical Activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 70 years;
  • obesity according to the WHO criteria (BMI ≥ 30); ù
  • written and informed consent to participate, 4) tech-friendly to receive feedback through smartphone, mail and wearable devices

Exclusion Criteria:

  • other severe psychiatric disturbance diagnosed by DSM-V criteria;
  • severe visual difficulties,
  • important limitations of movement, in particular subjects for which it is not recommended physical activity,
  • concurrent medical condition not related to obesity. DSM-V (Thomas et al., 2014) will be used as screening tools for psychiatric disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351712


Contacts
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Contact: Gian Luca Castelnuovo, PhD, PsyD 0039323514339 gianluca.castelnuovo@unicatt.it
Contact: Roberto Cattivelli, PhD, PsyD +393208955656 r.cattivelli@auxologico.it

Locations
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Italy
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS Not yet recruiting
Verbania, Italy, 28921
Contact: Gian Luca Castelnuovo, Ph.D.    0039323514338    gianluca.castelnuovo@auxologico.it   
Contact: Roberto Cattivelli, Ph.D.    0039323514246    r.cattivelli@auxologico.it   
Sub-Investigator: Roberto Cattivelli, Psy.D.         
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Gian Luca Castelnuovo, PhD, PsyD Istituto Auxologico Italiano

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gianluca Castelnuovo, Prof, Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT03351712     History of Changes
Other Study ID Numbers: ACTonHEALTH-protocol
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianluca Castelnuovo, Istituto Auxologico Italiano:
Wearables
Activity Trackers
ACT
Health promotion
Obesity
Chronic Health Condition
Psychological well-being
Quality of life
Behavior modification
RCT