ME-WEL (MEnopause and WEight Loss): Protocol of a Randomised Controlled eHealth Intervention for Weight Management and Well-being in Post-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Satisfaction with life scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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);
排除标准
- •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
结局指标
主要结局
Satisfaction with life scale
时间窗: 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)
Weight management strategies
时间窗: 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)
Positive and negative affect
时间窗: 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)
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)