OBEAT - Beating Obesity: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Follow up-rates - feasibility
研究概览
简要总结
The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women.
Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation.
This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.
详细描述
Phase 1: Planning In Phase 1 (6 months), the project will be developed and planned, and approvals from the Danish Data Protection Agency and Ethical Committee of the Capital Region to conduct the study will be obtained.
Validated questionnaires to measure perceived stress, sleep patterns, physical activity- and dietary habits will be selected and pilot tested.
Phase 2: Recruitment and data collection In Phase 2 (12 months), participants will be recruited and randomized. Pregnant women living in Denmark are offered public, antenatal care delivered by hospital employed midwives. Healthy, non-obese, pregnant women assigned to antenatal care and birth at Hvidovre Hospital, are routinely invited to a first antenatal midwife session at gestational week 14-18. At these sessions, participants will be informed and recruited to the feasibility study. In 8 weeks approximately 240 pregnant women will be eligible, thus 120 women corresponding to 50% of all eligible pregnant women in one month will be recruited. In this feasibility study 50% of the women will be randomised to the intervention group and introduced to the resilience internet-based program/ smart phone app and 50% will be randomised to the control group and receive standard care. Computer-based randomization procedures will be used.
Phase 3: Feasibility study evaluation In Phase 3 (19 months), the knowledge obtained in Phase 2 will be evaluated.
An effect evaluation of the project will be conducted by analysing the collected clinical data, primarily related to changes and correlations in chronic stress in mother and infant (measured by hair cortisol), perceived stress, physical activity- and dietary habits, infant birth length and weight, and gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Expecting first child
- •Speaks Danish
- •Non-obese (BMI < 30)
- •Singleton pregnancy
- •Visited to basic level midwife care
排除标准
- •Non-danish speakers
- •Type 1 or 2 diabetes
- •Visited to specialist midwife care for psychosocial reasons
- •Expecting twins
- •BMI > 30
- •Multipara
研究组 & 干预措施
Resilience program
The resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups
干预措施: Resilience program (Behavioral)
Standard care
Danish antenatal standard care is 3 visits at the general practitioner, 5 midwife controls and 2 ultrasound scans
结局指标
主要结局
Follow up-rates - feasibility
时间窗: Two months after birth
Number of participants in final clinical examination
Recruitment-rates - feasibility
时间窗: Two months after birth
Number of participants out of eligible pregnant women approached
Recruitment-time - feasibility
时间窗: Two months after birth
Number of days used to recruit the decided number of 120 participants
Attrition-rates - feasibility
时间窗: Two months after birth
Number of participants leaving the study before the end
Satisfaction-rates - feasibility
时间窗: Two months after birth
Measured from patient-reported questionnaire
Compliance-rates - feasibility
时间窗: Two months after birth
Use of resilience program measured from web-statistics
Self-reported compliance-rates - feasibility
时间窗: Two months after birth
Use of resilience program from patient-reported questionnaire
次要结局
- Change in maternal depression, anxiety and tension/stress.(Gestational week 14-18, 28, 35 and two months after birth)
- Changes in fetal health anxiety(Gestational week 14-18, 28, 35)
- Changes in participant's physical activity - transportation(Gestational week 14-18, 28, 35 and two months after birth)
- Change in maternal perceived stress(Gestational week 14-18, 28, 35 and two months after birth)
- Length - child(Birth and two months after birth)
- Head circumference - child(Birth and two months after birth)
- Change in maternal chronic stress(Gestational week 14-18, 28, 35, birth and two months after birth)
- Changes in maternal resilience(Gestational week 14-18, 28, 35 and two months after birth)
- Changes in fear of childbirth(Gestational week 14-18, 28, 35)
- Sleep patterns - mother(Gestational week 14-18, 28, 35 and two months after birth)
- Changes in participant's physical activity - exercise(Gestational week 14-18, 28, 35 and two months after birth)
- Changes in diet - mother(Gestational week 14-18, 28, 35 and two months after birth)
- Weight - child(Birth and two months after birth)
- Change in mentalization ability(Gestational week 14-18, 28, 35 and two months after birth)
- Changes in maternal Sense of Coherence (SOC)(Gestational week 14-18, 28, 35 and two months after birth)
- Differences in parental stress(Two months after birth)
- Weight - mother(Gestational week 14-18, 28, 35 and two months after birth)
研究者
Berit Lilienthal Heitmann
Professor, Principal investigator
Bispebjerg Hospital