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

Study Overview
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Brief Summary
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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 Taxonomy (BCTT). 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. 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.

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

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

Intervention / Treatment
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* Behavioral: Control Group: Delivery of a health literacy flyer
* Behavioral: Experimental Group: Weekly group sessions for weight management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group: Delivery of a health literacy flyer<br>All Control Group participants received, through e-mail, a flyer about health literacy. | Behavioral: Control Group: Delivery of a health literacy flyer<br>* 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).<br>|
| Experimental: Weekly group sessions for weight management<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 
| Satisfaction with life scale | Evaluated by Satisfaction with life scale (Diener et al., 1985) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Assessed by Body Mass Index (BMI) - weight and height will be combined to report BMI in kg/m^2 | Change from Baseline weight loss one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups | 
| Eating behaviour | Measured by the Three Factor Eating Questionnaire (TFEQ-R21; Cappelleri et al., 2009) | Change from Baseline eating behaviour one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups | 
| Physical Activity | Assessed by the International physical activity questionnaire (IPAQ; Craig et al., 2003) | Change from Baseline physical activity one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups | 
| Weight management strategies | Measured by the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW; Leitão et al., 2023) | 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 | 
| Self-esteem | Assessed by the Rosenberg Self-Esteem Scale (RSS; Rosenberg, 1965) | Change from Baseline self-esteem one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups | 
| Behaviour change (HAPA) | Assessed by HAPA Questionnaire (tailored to weight management), based on Godinho and collaborators' study (Godinho et al., 2014) | Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups | 
| Behaviour change (HBM) | Evaluated by HBM questionnaire (tailored to weight management), based on Saghafi-Asl and collaborators' study (2020). | Change from Baseline behaviour change one month after the intervention´s beginning, one week post-intervention, and at 3- and 6- months follow-ups |