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

Primary Purpose

Subjective Well-being, Weight Loss, Self Esteem

Status
Active
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Control Group: Delivery of a health literacy flyer
Experimental Group: Weekly group sessions for weight management
Sponsored by
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Subjective Well-being

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ispa - Instituto Universitário

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group: Delivery of a health literacy flyer

Weekly group sessions for weight management

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight loss
Assessed by Body Mass Index (BMI) - weight and height will be combined to report BMI in kg/m^2
Eating behaviour
Measured by the Three Factor Eating Questionnaire (TFEQ-R21; Cappelleri et al., 2009)
Physical Activity
Assessed by the International physical activity questionnaire (IPAQ; Craig et al., 2003)
Weight management strategies
Measured by the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW; Leitão et al., 2023)
Self-esteem
Assessed by the Rosenberg Self-Esteem Scale (RSS; Rosenberg, 1965)
Behaviour change (HAPA)
Assessed by HAPA Questionnaire (tailored to weight management), based on Godinho and collaborators' study (Godinho et al., 2014)
Behaviour change (HBM)
Evaluated by HBM questionnaire (tailored to weight management), based on Saghafi-Asl and collaborators' study (2020).

Full Information

First Posted
May 25, 2023
Last Updated
June 5, 2023
Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators
Fundação para a Ciência e a Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT05903157
Brief Title
ME-WEL: eHealth Behaviour Change Intervention for Weight Management in Post-menopausal Women
Acronym
ME-WEL
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
November 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Collaborators
Fundação para a Ciência e a Tecnologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Well-being, Weight Loss, Self Esteem, Physical Activity, Eating Behavior, Behavior and Behavior Mechanisms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group: Delivery of a health literacy flyer
Arm Type
Active Comparator
Arm Description
All Control Group participants received, through e-mail, a flyer about health literacy.
Arm Title
Weekly group sessions for weight management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group: Delivery of a health literacy flyer
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Experimental Group: Weekly group sessions for weight management
Intervention Description
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 Outcome Measure Information:
Title
Positive and negative affect
Description
Evaluated by "Short-Form of the Portuguese version of the positive and negative affect schedule - PANAS - Port - VRP" (Galinha et al., 2014)
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
Title
Satisfaction with life scale
Description
Evaluated by "Satisfaction with life scale" (Diener et al., 1985)
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
Secondary Outcome Measure Information:
Title
Weight loss
Description
Assessed by Body Mass Index (BMI) - weight and height will be combined to report BMI in kg/m^2
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
Title
Eating behaviour
Description
Measured by the Three Factor Eating Questionnaire (TFEQ-R21; Cappelleri et al., 2009)
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
Title
Physical Activity
Description
Assessed by the International physical activity questionnaire (IPAQ; Craig et al., 2003)
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
Title
Weight management strategies
Description
Measured by the Oxford Food and Activity Behaviors Taxonomy (OxFAB-MAW; Leitão et al., 2023)
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
Title
Self-esteem
Description
Assessed by the Rosenberg Self-Esteem Scale (RSS; Rosenberg, 1965)
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
Title
Behaviour change (HAPA)
Description
Assessed by HAPA Questionnaire (tailored to weight management), based on Godinho and collaborators' study (Godinho et al., 2014)
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
Title
Behaviour change (HBM)
Description
Evaluated by HBM questionnaire (tailored to weight management), based on Saghafi-Asl and collaborators' study (2020).
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filipa Pimenta, Ph.D.
Organizational Affiliation
WJCR, Ispa - Instituto Universitário
Official's Role
Study Chair
Facility Information:
Facility Name
Ispa - Instituto Universitário
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1600
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23512568
Citation
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.
Results Reference
background
PubMed Identifier
36687937
Citation
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.
Results Reference
background
PubMed Identifier
24308823
Citation
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.
Results Reference
background
PubMed Identifier
34015038
Citation
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.
Results Reference
background

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

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