The Effects of Exercise and Dietary Interventions in Overweight and Obese Postpartum Women on Weight Management and Health.
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in BMI
研究概览
简要总结
The current study aims to investigate the effects of a chosen technology-based exercise or healthy eating intervention that combines individual and group-based support, on weight loss and other health-related parameters in postpartum women with overweight or obesity. All participants will be asked to engage in a 20-week programme consisting of a 4 week tracked free living period followed by a 16-week intervention. The investigators hypothesise that reductions in BMI (body mass index) and improvements in health-related parameters will be observed post-intervention.
详细描述
The current study will investigate the effects of a chosen exercise or dietary intervention on BMI and other health-related parameters in postpartum women with overweight and obesity. Dietary or physical activity interventions, alone or combined, are associated with greater weight loss when provided to women in the postpartum period, compared with no intervention. Providing a combined physical activity and dietary intervention is associated with an average weight loss of 2.49kg post-intervention and 2.4kg 12 months after pregnancy. However, the variation in average weight loss achieved is great which could be due to differences in the design of lifestyle programmes.
Interventions including individualised support and self-monitoring have proven more effective in promoting reductions in BMI in postpartum women. However, high levels of attrition and poor engagement have been highlighted as two areas that require attention in this area. Therefore, future research is required to identify strategies best suited to the design and implementation of effective lifestyle interventions in overweight and obese postpartum women.
Women between six weeks and one year postpartum will elect to be part of either a 16-week exercise or dietary intervention. Prior to this, participants will be tracked for a period of four weeks in free living conditions. Each intervention will be split into four blocks of three weeks where staged intervention specific information will be provided. Individualised face-to-face and technological group support will be provided throughout. For the final four weeks of the intervention no new information will be provided and all support will be withdrawn.
Analyses of body composition and girths, blood metabolites, resting heart rate, blood pressure, and questionnaires assessing physical activity, eating behaviours and quality of life will be carried out alongside assessments of BMI at baseline, pre-intervention and at both twelve and sixteen weeks of the intervention. Measures of BMI, resting heart rate, blood pressure and questionnaire scores will be taken at each three weekly stage of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years old at the date of their first visit. Have a body mass index (BMI) of greater than 25 kg∙m2 (this will be worked out by the researchers using the participant's height and body weight). Have had a singleton pregnancy. Have had one pregnancy to date. Be 6 weeks-1 year postpartum (and had physician's approval to return to exercise).
- •Own a smartphone (able to download and use WhatsApp). In the researcher's opinion, the participant is able and willing to follow all trial requirements.
排除标准
- •Have a clinical diagnosis of depression/postnatal depression. Currently enrolled on another weight loss programme. Currently consuming weight loss tablets/supplements. Have heart/liver/chronic renal disease. Have a clinical diagnosis of Type 2 Diabetes Mellitus. Consume excessive amounts of alcohol (regularly drinking more than 14 units of alcohol a week). Actively trying for another baby/planning a pregnancy in the next 6 months. Experienced a stillbirth. Have any health conditions that affect physical activity engagement. On any medication that affects the ability to exercise. On any medication that affects the ability to follow a healthy eating programme.
研究组 & 干预措施
Exercise Intervention
Exercise intervention with the aim of incrementally increasing physical activity to meet the national recommendation of 150 minutes a week of moderate-vigorous physical activity, reducing BMI and improving overall health.
干预措施: Exercise Intervention (Behavioral)
Dietary Intervention
Staged dietary intervention with the aim of improving eating behaviours, reducing BMI and improving overall health.
干预措施: Dietary Intervention (Behavioral)
结局指标
主要结局
Changes in BMI
时间窗: Week 0, 4, 7, 10, 13, 16, 20
Weight (kg) and height (m) will be combined to report BMI in kg/m\^2
次要结局
- Change in Resting Heart Rate(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Body Girths(Week 0, 4, 16, 20)
- Change in Quality of Life(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Blood Metabolites(Week 0, 4, 16, 20)
- Change in Blood Pressure(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Eating Behaviours(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Body Composition(Week 0, 4, 16, 20)
- Change in Sleep Quality(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Physical Activity Levels(Week 0, 4, 7, 10, 13, 16, 20)
- Change in Markers of Postnatal Depression(Week 0, 4, 7, 10, 13, 16, 20)
研究者
Stephanie Hanley
Miss
Nottingham Trent University