Clinical Trials Directory

Trials / Completed

CompletedNCT05903157

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

ME-WEL (MEnopause and WEight Loss): Protocol of a Randomised Controlled eHealth Intervention for Weight Management and Well-being in Post-Menopausal Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida · Academic / Other
Sex
Female
Age
45 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALControl Group: Delivery of a health literacy flyerA health literacy flyer was delivered, by e-mail, in the first week of the intervention (the flyer contained its original source - the European Centre for Disease Prevention and Control). Beyond this, there was no further interaction with the group. All primary and secondary outcome measures were assessed at baseline, one month later (in the middle of the intervention), post-intervention, and follow-up moments (3 and 6 months after the intervention).
BEHAVIORALExperimental Group: Weekly group sessions for weight managementThe eHealth intervention was designed based on: i) the Health Action Process Approach determinants, ii) the Health Belief Model constructs, and iii) behaviour change techniques (BCT, Taxonomy v1, by Michie et al., 2013) to implement healthy behaviours. The intervention consists of 8 sessions (90 minutes, once a week). All group intervention sessions, through the Zoom platform, are led by the psychologist responsible for the study. Whatsapp groups were created, to share experiences, knowledge, doubts, fears... All primary and secondary outcome measures were assessed at baseline, one month later (in the middle of the intervention), post-intervention, and in follow-up moments (3 and 6 months after the intervention).

Timeline

Start date
2023-03-28
Primary completion
2023-05-19
Completion
2023-11-29
First posted
2023-06-15
Last updated
2024-06-28

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT05903157. Inclusion in this directory is not an endorsement.