CClinicalTrials.gg
CompletedNCT05903157ME-WELUpdated Jun 28, 2024

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

An interventional study of Control Group: Delivery of a health literacy flyer and Experimental Group: Weekly group sessions for weight management in Subjective Well-being, Weight Loss and Self Esteem, sponsored by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida. Completed at 1 site in Portugal. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

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.

02

Conditions studied

  • Subjective Well-being
  • Weight Loss
  • Self Esteem
  • Physical Activity
  • Eating Behavior
  • Behavior and Behavior Mechanisms
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 35 is below the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida is the lead sponsor of 11 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    Control Group: Delivery of a health literacy flyer

    All Control Group participants received, through e-mail, a flyer about health literacy.

    Behavioral: Control Group: Delivery of a health literacy flyer

  • Experimental
    Weekly group sessions for weight management

    Participants in the Experimental Group were integrated into an eHealth 8-week group intervention, based on two theoretical models - the Health Action Process Approach (HAPA), and the Health Belief Model (HBM). Several Behaviour Change Techniques (BCT) were used, to promote the behaviour change. The experimental intervention consisted of: i) weekly group sessions (by Zoom platform), with a specific theme in each session, ii) weekly challenges, and iii) WhatsApp group interaction.

    Behavioral: Experimental Group: Weekly group sessions for weight management

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).

06

What researchers measure

Primary outcomes

  1. Positive and negative affect

    Evaluated by "Short-Form of the Portuguese version of the positive and negative affect schedule - PANAS - Port - VRP" (Galinha et al., 2014)

    Time frame: 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

  2. Satisfaction with life scale

    Evaluated by "Satisfaction with life scale" (Diener et al., 1985)

    Time frame: 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

  3. Weight management strategies

    Measured by the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW; Leitão et al., 2023)

    Time frame: 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

Secondary outcomes

  1. Weight loss

    Assessed by Body Mass Index (BMI) - weight and height will be combined to report BMI in kg/m\^2

    Time frame: Change from Baseline weight loss one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

  2. Eating behaviour

    Measured by the Three Factor Eating Questionnaire (TFEQ-R21; Cappelleri et al., 2009)

    Time frame: Change from Baseline eating behaviour one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

  3. Physical Activity

    Assessed by the International physical activity questionnaire (IPAQ; Craig et al., 2003)

    Time frame: Change from Baseline physical activity one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

  4. Self-esteem

    Assessed by the Rosenberg Self-Esteem Scale (RSS; Rosenberg, 1965)

    Time frame: Change from Baseline self-esteem one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

  5. Behaviour change (HAPA)

    Assessed by HAPA Questionnaire (tailored to weight management), based on Godinho and collaborators' study (Godinho et al., 2014)

    Time frame: Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

  6. Behaviour change (HBM)

    Evaluated by HBM questionnaire (tailored to weight management), based on Saghafi-Asl and collaborators' study (2020).

    Time frame: Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups

07

Study locations

1 site
  • Ispa - Instituto Universitário
    Lisbon, Lisboa 1600, Portugal
08

References and documents

Publications

  • Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6. PubMed 23512568 ↗
  • Leitao M, Hartmann-Boyce J, Perez-Lopez FR, Maroco J, Pimenta F. Weight management strategies in Middle-Aged Women (MAW): Development and validation of a questionnaire based on the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW) in a Portuguese sample. Front Psychol. 2023 Jan 4;13:1069775. doi: 10.3389/fpsyg.2022.1069775. eCollection 2022. PubMed 36687937 ↗
  • Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Will is not enough: coping planning and action control as mediators in the prediction of fruit and vegetable intake. Br J Health Psychol. 2014 Nov;19(4):856-70. doi: 10.1111/bjhp.12084. Epub 2013 Dec 6. PubMed 24308823 ↗
  • Saghafi-Asl M, Aliasgharzadeh S, Asghari-Jafarabadi M. Correction: Factors influencing weight management behavior among college students: An application of the Health Belief Model. PLoS One. 2021 May 20;16(5):e0252258. doi: 10.1371/journal.pone.0252258. eCollection 2021. PubMed 34015038 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05903157
Lead sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators
Fundação para a Ciência e a Tecnologia
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Mar 28, 2023
Primary completion
May 19, 2023
Completion
Nov 29, 2023
Last update
Jun 28, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion