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Completed

NCT Number: NCT05903157

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

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.

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Key information

Conditions

Subjective Well-being Behavior Behavior and Behavior Mechanisms Behavior, Animal Body Weight Body Weight Changes Eating Behavior Feeding Behavior Motor Activity Pathological Conditions, Signs and Symptoms Physical Activity Self Esteem Signs and Symptoms Weight Loss

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ispa - Instituto Universitário

Lisbon, Lisbon District, 1600, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group: Delivery of a health literacy flyer

Behavioral

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).

Experimental Group: Weekly group sessions for weight management

Behavioral

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).

Primary outcomes

  1. Positive and negative affect

    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

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

  2. Satisfaction with life scale

    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

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

  3. Weight management strategies

    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

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

Secondary outcomes

  1. Weight loss

    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

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

  2. Eating behaviour

    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

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

  3. Physical Activity

    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

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

  4. Self-esteem

    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

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

  5. Behaviour change (HAPA)

    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

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

  6. Behaviour change (HBM)

    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

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Acronym: ME-WEL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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