Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05903157
Acronym
ME-WEL
Enrollment
35
Registered
2023-06-15
Start date
2023-03-28
Completion date
2023-11-29
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior and Behavior Mechanisms, Eating Behavior, Physical Activity, Self Esteem, Subjective Well-being, Weight Loss

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.

Interventions

BEHAVIORALControl Group: Delivery of a health literacy flyer

A 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 management

The 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).

Sponsors

Fundação para a Ciência e a Tecnologia
CollaboratorOTHER
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026