ME-WEL: eHealth Behaviour Change Intervention for Weight Management in Post-menopausal Women

Not Applicable

Completed

• Conditions: Eating Behavior; Physical Activity; Behavior and Behavior Mechanisms; Weight Loss; Subjective Well-being; Self Esteem

• Registration Number: NCT05903157
• Lead Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Brief Summary

In post-menopause, most women gain weight, and obesity rates are more prevalent in this particular group. In addition, there is an increased risk of cardiovascular disease, cancer, and diabetes. Given that this weight gain can be related to risk behaviours, healthy weight management (such as an increase in physical activity or healthy eating) is crucial to promote a healthy weight and well-being.

The ME-WEL (MEnopause and WEigth Loss) project (ref. SFRH/BD/144525/2019), entails an eHealth intervention for weight management and well-being in post-menopausal women with overweight or obesity, based on two theoretical models of behavioral change - the Health Action Process Approach (HAPA), and the Health Belief Model (HBM), and applying the Behaviour Change Techniques (BCT) Taxonomy and Oxford Food and Activity Behaviors (OxFAB) Taxonomy.

This group's eHealth intervention lasts 8 weeks. Each week there is a different theme to be addressed, taking into account the behavioral change models mechanisms, in articulation with different BCT´s and weight strategies.

Subjective well-being, self-esteem, weight loss, implementation of weight management strategies, and changes in eating behavior and physical activity/exercise were evaluated, through follow-ups at 3- and 6- post-intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Primary Completion: 2023-05-19
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Study Completion: 2023-11-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• Age (45-65 years);
• Post-menopausal women (which starts after menopause/last period, confirmed by 12-month amenorrhea);
• Women with a Body Mass Index (BMI) of 25 kg/m2 or more (overweight) or women with a BMI of 30 kg/m2 or more (obesity);
• Nationality (Portuguese or dual nationality);

Exclusion Criteria

• Specifical diseases and/or medical reasons to limit activity (stroke, cancer, diabetes, heart disease, epilepsy, musculoskeletal problems that severely compromise mobility; loss of functional ability);
• Diagnosis of mental health illness or recent hospitalization for mental health reasons;
• History of alcohol dependence;
• History of addiction to illicit substances;
• Suicidal ideation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Satisfaction with life scale	Change from Baseline satisfaction with life scale one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Evaluated by "Satisfaction with life scale" (Diener et al., 1985)
Weight management strategies	Change from Baseline weight management strategies one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Measured by the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW; Leitão et al., 2023)
Positive and negative affect	Change from Baseline positive and negative affect one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Evaluated by "Short-Form of the Portuguese version of the positive and negative affect schedule - PANAS - Port - VRP" (Galinha et al., 2014)

Secondary Outcome Measures

Name	Time	Method
Eating behaviour	Change from Baseline eating behaviour one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Measured by the Three Factor Eating Questionnaire (TFEQ-R21; Cappelleri et al., 2009)
Self-esteem	Change from Baseline self-esteem one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Assessed by the Rosenberg Self-Esteem Scale (RSS; Rosenberg, 1965)
Behaviour change (HAPA)	Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Assessed by HAPA Questionnaire (tailored to weight management), based on Godinho and collaborators' study (Godinho et al., 2014)
Behaviour change (HBM)	Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Evaluated by HBM questionnaire (tailored to weight management), based on Saghafi-Asl and collaborators' study (2020).
Physical Activity	Change from Baseline physical activity one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Assessed by the International physical activity questionnaire (IPAQ; Craig et al., 2003)
Weight loss	Change from Baseline weight loss one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups	Assessed by Body Mass Index (BMI) - weight and height will be combined to report BMI in kg/m\^2

Trial Locations

Locations (1)

Ispa - Instituto Universitário; 🇵🇹 Lisbon, Lisboa, Portugal