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

• Sponsor: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05903157
• Collaborator: Fundação para a Ciência e a Tecnologia (Other)
• Enrollment: 35
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Subjective Well-being; Weight Loss; Self Esteem; Physical Activity; Eating Behavior; Behavior and Behavior Mechanisms	Behavioral: Control Group: Delivery of a health literacy flyer; Behavioral: Experimental Group: Weekly group sessions for weight management	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: ME-WEL (MEnopause and WEight Loss): Protocol of a Randomised Controlled eHealth Intervention for Weight Management and Well-being in Post-Menopausal Women
• Actual Study Start Date: Mar 28, 2023
• Actual Primary Completion Date: May 19, 2023
• Anticipated Study Completion Date: Nov 29, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Positive and negative affect [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 [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)

Secondary Outcome Measures

1. 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]

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

2. 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]

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

3. 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]

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

4. Weight management strategies [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)

5. 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]

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

6. 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]

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

7. Behaviour change (HBM) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ispa - Instituto Universitário	Lisbon	Lisboa	Portugal	1600

Sponsors and Collaborators

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

Investigators

• Study Chair: Filipa Pimenta, Ph.D., WJCR, Ispa - Instituto Universitário

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
• ClinicalTrials.gov Identifier: NCT05903157
• Other Study ID Numbers: SFRH/BD/144525/2019
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Jun 15, 2023