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

NCT05903157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-28

No results posted yet for this study

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

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

Interventions

BEHAVIORAL

Control 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).

BEHAVIORAL

Experimental 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 & Collaborators

  • Fundação para a Ciência e a Tecnologia

    collaborator OTHER
  • ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

    lead OTHER

Principal Investigators

  • Filipa Pimenta, Ph.D. · WJCR, Ispa - Instituto Universitário

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2023-05-19
Completion
2023-11-29

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903157 on ClinicalTrials.gov