Group intervention for women with overweight or obesity

ISRCTN	ISRCTN29129189
DOI	https://doi.org/10.1186/ISRCTN29129189
Sponsors	University of Bío-Bío, Universidad del Desarrollo
Funder	Agencia Nacional de Investigación y Desarrollo

Submission date: 18/02/2026
Registration date: 19/02/2026
Last edited: 19/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
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

Not provided at time of registration

Contact information

Dr Andrea María Palma Contreras
Public, Scientific

Avenida Brasil 1180
Chillan
3800708
Chile

ORCID ID	0000-0002-6281-1509
Phone	+56-413111200
Email	andrea.m.palma.c@gmail.com

Dr Andrea María Palma Contreras
Principal investigator

Avenida Brasil 1180
Chillan
3800708
Chile

ORCID ID	0000-0002-6281-1509
Phone	+56-413111200
Email	apalma@ubiobio.cl

Dr Josefina Larraín Valenzuela
Scientific

Avenida Plaza 680, Las Condes, Santiago
Santiago
7610315
Chile

Phone	+56 800 200 125
Email	josefinalarrain@udd.cl

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Cluster (OMS definitions)
Purpose	Treatment
Scientific title	Effectiveness of a family-focused group intervention centered on self-regulatory capacity in women with overweight or obesity to promote healthier habits
Study objectives
Ethics approval(s)	Approved 05/12/2025, Comité Ético Científico del Servicio de Salud Metropolitano Sur (Avenida Santa Rosa 3453. San Miguel, Santiago, 8900000, Chile; +56-225763637; comiteeticocientifico@ssms.gob.cl), ref: 142-01122025
Health condition(s) or problem(s) studied	Treatment of overweight and obesity
Intervention	Experimental Group: Family Attachment Therapy developed by Claudia Messing, focused on self-regulation. 8 group sessions, 2 hours each, every two weeks, for 4 months with each group (there will be two experimental groups), in groups of 8 women. The therapy will be led by a clinical psychologist specializing in family attachment therapy and eating disorders. The therapeutic content will include exploring bonds with family of origin and current family, identifying relational patterns that influence family dynamics and eating habits, addressing psycho-affective transference associated with food, role overload, mimicry of parental figures, repetition of family experiences, and healthy boundaries. The aim is to foster emotional self-regulation through verbalization of distress linked to family history; alternatives to immediate gratification mediated by food; and work on body image/schema, self-care, and self-concept/self-esteem. Techniques will include mindfulness, cognitive restructuring, and behavioral strategies. Control Group: This group will not receive the project intervention. They will continue with the regular activities of the Choose Healthy Living Program, with access to timely referrals if necessary and monitoring within the program. Group Assignment and Randomization: Assignment to the experimental and control groups will be done via random numbers generated in Excel. Participants are organized into groups of 8 according to clinical-therapeutic objectives; the groups remain fixed throughout the process (without modifications). Regarding the evaluation schedule, it should be noted that measurements for both groups will be taken at three points: before (baseline), at the end of the interventions, and at a 6-month post-treatment follow-up. There will be two experimental groups and two control groups of 8 people each, in two phases of 4 months each. This is a group psychotherapeutic intervention; no medications or routes of administration are reported. Recruitment to compensate for dropout: in order for 64 to complete the 3 measurements, it is planned to recruit 82 women (18 additional), and attendance at sessions will be considered in the analyses.
Intervention type	Behavioural
Primary outcome measure(s)	Self‑regulatory capacity measured using a latent variable constructed from physical, psychological, and relational indicators using all listed instruments at pretest, posttest (4 months), and 6‑month follow‑up Body mass index (BMI; kg/m²) measured using standard anthropometric assessment at pretest, posttest (4 months), and 6‑month follow‑up Body composition measured using the InBody 270 at pretest, posttest (4 months), and 6‑month follow‑up Emotional eating measured using Emotional Eater Questionnaire (EEQ) at pretest, posttest (4 months), and 6‑month follow‑up Eating behavior measured using Three‑Factor Eating Questionnaire (TFEQ) at pretest, posttest (4 months), and 6‑month follow‑up Physical activity measured using International Physical Activity Questionnaire, long version (IPAQ‑long) at pretest, posttest (4 months), and 6‑month follow‑up Self‑concept measured using AF5 at pretest, posttest (4 months), and 6‑month follow‑up Psychological symptoms, traits, and functioning measured using PAI at pretest, posttest (4 months), and 6‑month follow‑up Traits associated with eating‑related psychopathology measured using EDI‑3 at pretest, posttest (4 months), and 6‑month follow‑up Interpersonal attachment style measured using Vinculatest at pretest, posttest (4 months), and 6‑month follow‑up Family functioning (cohesion, flexibility, communication, and total index) measured using FACES IV at pretest, posttest (4 months), and 6‑month follow‑up
Key secondary outcome measure(s)
Completion date	11/11/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Female
Target sample size at registration	64
Total final enrolment	82
Key inclusion criteria	1. Women 2. Aged 18–60 years 3. With a clinical diagnosis of overweight or obesity (BMI ≥ 25 kg/m²) 4. Participants in the Elige Vida Sana Program in El Bosque 5. Willing to attend group sessions every 15 days for 4 months 6. Having signed the informed consent form to participate in the study and to allow the use of their data for research purposes
Key exclusion criteria	1. Presence of severe psychiatric disorders (such as schizophrenia, uncontrolled bipolar disorder, active suicidal ideation, or substance use disorders) that limit active participation in a group process as indicated in the clinical record or through prior screening 2. Pregnant women or those exclusively breastfeeding, since weight change would not be comparable and they may require different nutritional interventions 3. Severe mobility problems or decompensated chronic illnesses that prevent sustained, in-person participation in group sessions 4. Significant difficulties understanding spoken or written Spanish, or unaccommodated sensory disabilities that prevent full participation in group activities
Date of first enrolment	09/03/2026
Date of final enrolment	30/01/2027

Locations

Countries of recruitment

Chile

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

19/02/2026: Trial's existence confirmed by Comité Ético Científico del Servicio de Salud Metropolitano Sur.