mACTonHEALTH: Psychological Flexibility and Activity Tracker - Protocol

NCT03351712 | Recruiting

• 1 other identifier: 03C701
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

Wearables; Activity Trackers; ACT; Health promotion; Obesity; Chronic Health Condition; Psychological well-being; Quality of life; Behavior modification; RCT

Outcome Measures

Primary Outcomes (1)

• Physical Activity directly measured by wearable devices Daily STEPS Count

  Daily Steps directly collected by wearable devices

  Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

Secondary Outcomes (4)

• MDS - Mediterranean Diet Score

  Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

• PGWBI - Psychological General Well-Being Index

  Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

• Acceptance & Action Questionnaire AAQ-II

  Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

• International Physical Activity Questionnaires (IPAQ-SF)

  Baseline - after 4 weeks treatment - 6 months Follow Up - 12 months Follow Up - 18 months Follow Up -

Study Arms (4)

Gold Standard Intervention + Activity Tracker WITHOUT Feedback

ACTIVE COMPARATOR

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

Gold Standard Intervention and Activity Tracker WITH Feedback

EXPERIMENTAL

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

ACT-Based Intervention and Activity Tracker WITHOUT Feedback

EXPERIMENTAL

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 and Activity Tracker WITH Feedback

EXPERIMENTAL

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

Interventions

ACT-Based Intervention and Activity Tracker WITH Feedback BEHAVIORAL

Combining ACT and Behavioral Change

ACT-Based Intervention and Activity Tracker WITH Feedback

Gold Standard Intervention + Activity Tracker WITHOUT Feedback BEHAVIORAL

Medical Rehabilitation, Motivational Support and Psycho-Education

Gold Standard Intervention + Activity Tracker WITHOUT Feedback

Gold Standard Intervention and Activity Tracker WITH Feedback BEHAVIORAL

Behavioral Change Condition - Activity Tracker

Gold Standard Intervention and Activity Tracker WITH Feedback

ACT-Based Intervention and Activity Tracker WITHOUT Feedback BEHAVIORAL

ACT-Based Intervention Standalone

ACT-Based Intervention and Activity Tracker WITHOUT Feedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, 28921, Italy

RECRUITING

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MeSH Terms

Conditions

Health Behavior; Obesity; Psychological Well-Being

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Gian Luca Castelnuovo, PhD, PsyD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Luca Castelnuovo, PhD, PsyD

CONTACT

0039323514339; gianluca.castelnuovo@unicatt.it

Roberto Cattivelli, PhD, PsyD

CONTACT

+393208955656; r.cattivelli@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single subject design and group design combined

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 24, 2017
• Study Start: November 11, 2020
• Primary Completion: March 31, 2024
• Study Completion: November 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

IT (1)