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

NCT05903157 | Completed

• 1 other identifier: SFRH/BD/144525/2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Weight loss

  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

  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

  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

  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)

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

Study Arms (2)

Control Group: Delivery of a health literacy flyer

ACTIVE COMPARATOR

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

Behavioral: Control Group: Delivery of a health literacy flyer

Weekly group sessions for weight management

EXPERIMENTAL

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

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).

Control Group: Delivery of a health literacy flyer

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).

Weekly group sessions for weight management

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Ispa - Instituto Universitário

Lisbon, Lisbon District, 1600, Portugal

Location

Related Publications (4)

• 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.

  PMID: 23512568 BACKGROUND

• 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.

  PMID: 36687937 BACKGROUND

• 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.

  PMID: 24308823 BACKGROUND

• 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.

  PMID: 34015038 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Motor Activity; Feeding Behavior; Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal

Study Officials

• Filipa Pimenta, Ph.D.

  WJCR, Ispa - Instituto Universitário

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: March 28, 2023
• Primary Completion: May 19, 2023
• Study Completion: November 29, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)