Psycho-nutritional intervention to reduce weight and improve body image and self-esteem in people who are overweight or obese

ISRCTN	ISRCTN31887061
DOI	https://doi.org/10.1186/ISRCTN31887061
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CPMS55773
Sponsor	Universidad Católica San Antonio de Murcia
Funder	Investigator initiated and funded

Submission date: 27/10/2023
Registration date: 10/11/2023
Last edited: 10/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The current growing levels of prosperity have led to habits such as inactivity and high-calorie diets, which can result in overweight and obesity. These diseases are associated with decreases in self-esteem and deterioration of body image, ultimately leading to psychological disorders such as depression and anxiety. The aim of this study is to assess the suitability of a psycho-nutritional model to improve the perception of body image and increase the self-esteem of individuals who are overweight or obese.

Who can participate?
Overweight and obese individuals who are aged between 25 and 70 years old

What does the study involve?
The study involves a cognitive-behavioral and nutritional intervention and there will be measurements of weight, self-esteem, and perception of body image obtained at specific time points throughout the study.

What are the possible benefits and risks of participating?
The possible benefits include weight loss and improvements in self-esteem and body image. There are no expected risks.

Where is the study run from?
San Antonio Catholic University of Murcia (Universidad Católica San Antonio de Murcia) (Spain)

When is the study starting and how long is it expected to run for?
March 2015 to March 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Elvira González Fernández, egonzalez495@alu.ucam.edu

Contact information

Mrs Elvira González Fernández
Public, Scientific, Principal investigator

Rúa Fray Juan de Navarrete, 4
Pontevedra
36001
Spain

ORCID ID	0009-0005-9300-4434
Phone	+34 (0)986864321
Email	egonzalez495@alu.ucam.edu

Dr Julia Navas López
Principal investigator

Faculty of Pharmacy and Nutrition
Catholic University of Murcia (UCAM)
Campus de los Jerónimos s/n
Murcia
30107
Spain

ORCID ID	0009-0000-4597-3306
Phone	+34 (0)968 278 800
Email	jnavas@ucam.edu

Study information

Primary study design	Interventional
Study design	Quasi-experimental study with repeated pretest-posttest measurements
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Psycho-nutritional intervention to improve the self-concept of body image and increase self-esteem of overweight and obese individuals
Study objectives	The aim of the present study was to assess the suitability of a psycho-nutritional model to improve the perception of body image and increase the self-esteem of individuals who are overweight or obese
Ethics approval(s)	Approved 22/07/2022, Catholic University of Murcia (UCAM) (Campus de los Jerónimos s/n. 30107 Guadalupe, Murcia., 30107, Spain; +34968278800; info@ucam.edu), ref: CE072205
Health condition(s) or problem(s) studied	Overweight and obese individuals
Intervention	This is a quasi-experimental study with repeated pretest-posttest measurements of a single group, without a group control, with three differentiated moments in time (pretest, posttest, and follow-up a year after the end of the therapeutic process). The procedure will be implemented in such a way that initial significant achievements in overweight and obesity are obtained through a psycho-nutritional program. This intervention will begin in 2015 with data collected until 2018, by asking for the voluntary, anonymous, and confidential participation of users who visited a private clinical nutrition center in Galicia (Spain) to ask for services to treat overweight and obesity. A cognitive-behavioral and nutritional intervention is applied. The intervention will be performed by a psychologist who is also a nutritionist. Thus, the users are informed that they will be assigned a numerical tag to associate their data, which are collected at three separate points in time (before the intervention [pretest], at the end of the intervention [post-test], and a year after discharge [follow-up]). Before collecting information, the participants were informed in detail about the objectives and the content of the study, after which they signed the informed consent form. At all times, they have ensured the confidentiality of the information collected, according to the ethical guidelines of the Declaration of Helsinki, aside from the approval from the Ethics Committee from the Catholic University of Murcia, Spain. The number of kilos lost in each case will be agreed upon with the users, who are also informed that the intervention will last between 15 to 20 weekly therapeutic sessions through which reductions in weight between 1 and 5 kg can be obtained.
Intervention type	Behavioural
Primary outcome measure(s)	1. Weight measured using a digital floor scale at the end of the intervention and at follow-up (a year after the end of the intervention)
Key secondary outcome measure(s)	The following secondary outcome measures were assessed before the intervention (at the pretest), at the end of the intervention (posttest) and a year after discharge (follow-up): 1. Self-esteem measured using the Rosenberg Self-Esteem Scale (RSES) 2. Self-evaluation of body image using the Body-Esteem Scale (BES)
Completion date	25/07/2023

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	25 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	55
Total final enrolment	55
Key inclusion criteria	1. Men and women 2. Between 25 and 70 years old 3. Overweight and obese individuals
Key exclusion criteria	1. Normal weight 2. Over 70 years old 3. Under 25 years of age
Date of first enrolment	20/03/2018
Date of final enrolment	07/03/2020

Locations

Countries of recruitment

Spain

Study participating centre

Euromedical

Rua Garcia Camba, 14
Pontevedra
36001
Spain

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Elvira González Fernández (evirgalicia@gmail.com). The data that will be provided will be the results obtained in the different measurement instruments used, always from the confidentiality and anonymity of the participants who gave their consent.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/11/2023: Study's existence confirmed by the Catholic University of Murcia (UCAM).