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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Weight Loss; Eating Behavior; Behavior and Behavior Mechanisms; Self Esteem; Subjective Well-being
• Intervention / Treatment: Behavioral: Control Group: Delivery of a health literacy flyer; Behavioral: Experimental Group: Weekly group sessions for weight management

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1600
      • Ispa - Instituto Universitário

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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: 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; 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).

What is the study measuring?

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
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

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
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

Collaborators and Investigators

• Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
• Collaborators: Fundação para a Ciência e a Tecnologia
• Investigators: Study Chair: Filipa Pimenta, Ph.D., WJCR, Ispa - Instituto Universitário

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): May 19, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: SFRH/BD/144525/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No