The Experience of Affective Touch in Obesity

Obesity Clinical Trial

— AffTouch_OB  

Official title:

The Experience of Affective Touch in Obesity: the Role of Social Anhedonia and Lifespan Experiences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768685
• Other study ID #: 21C128
• Status: Recruiting
• Start date: October 13, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Federica Scarpina, PhD
• Phone: +39032351
• Email: f.scarpina[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present research is to verify if the pleasantness of affective touch is comparable between women with obesity and healthy women, while measuring the level of social anhedonia and the lifespan experience of affective touch.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• right-handed;

• diagnosis of obesity (i.e., the level of body mass index (BMI( greater than or equal to 30).

Exclusion Criteria:

• Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

• Evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars).

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Affective touch paradigm
Affective touch paradigm: experimental stimuli will include the touch of a soft cosmetic, a hand, which will be both expected to resemble affective pleasant stimulations, and a plastic stick with a rounded tip, as a control (non-affective) condition. Two speeds of stimulation will be adopted i) slow affective stimuli delivered at 3 cm/s and fast non-affective stimuli, delivered at non-optimal speed (18 cm/s). An imagery version of the task will be also administered: blindfolded participants will be asked to image the touches on their left forearm. After each (actual or imagined) tactile stimulus, individuals will rate the experience level of pleasantness. As part of the protocol, they will fill out two psychological questionnaires, assessing the level of social anhedonia and the amount and characteristics of the lifespan experiences of affective touch inclose relationships.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe	Piancavallo	VCO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of subjective pleasantness	Behavioural outcome associated with the experimental paradigm: participants will be asked to rate the pleasantness of the tactile stimuli after each stimulation with a score ranging from zero not pleasant at all) to 100 (extremely pleasant).	baseline
Secondary	Social anhedonia score	Social anhedonia will be evaluated with the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS, Gooding and Pflum, 2014); this is a 17-item self-report measure of individuals' tendency to look forward to interactions with others (anticipatory interpersonal pleasure - 7 items) and experienced pleasure in social interactions (consummatory interpersonal pleasure - 10 items). The ACIPS is scored on a Likert scale ranging from 1 (very false for me) to 6 (very true for me); higher scores indicate higher anticipatory and consummatory interpersonal pleasure.	baseline
Secondary	Affective experience score	The lifespan experience of affective touch in close relationships will be assessed with the Tactile Biography questionnaire (TBIO, Beltrán et al., 2020). This includes a 29-item self-report measure scored on a Likert scale ranging from 1 (e.g., not at all true for me) to 5 (e.g., extremely true) that evaluate four independent components: the frequency of and satisfaction for affective touch i) in childhood/adolescence and ii) adulthood, iii) comfort with and iv) fondness for interpersonal touch in close relationships	baseline