NCT05768685

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

February 22, 2023

Last Update Submit

August 20, 2025

Conditions

Keywords

affective touchsocial anhedonialifespan bodily contactsinterpersonal relationships

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Social anhedonia score

    baseline

  • Affective experience score

    baseline

Study Arms (2)

Cases

Right-handed women diagnosed with obesity will be consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders will be exclusion criteria, as well as the evidence of any skin-related condition possibly affecting sensitivity on the participants' forearm (e.g., eczema, scars)

Behavioral: Affective touch paradigm

Controls

Age-matched, right-handed, healthy women (i.e., with no history of eating disorders) will be recruited outside the hospital through personal contacts of the researchers and word-of-mouth.

Behavioral: Affective touch paradigm

Interventions

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.

CasesControls

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants with obesity will be consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

ObesityAnhedonia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 14, 2023

Study Start

October 13, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations