OBEAT - Beating Obesity
Condition: Pregnancy Related; Obesity, Childhood; Stress
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      A process evaluation will also be conducted. The Committee of Health Education will collect
      data on how much and what parts of the resilience program has been used by the participating
      pregnant women. In addition, the participants will be asked to complete a short questionnaire
      on how frequent and how satisfied they have been with using the program. The researchers also
      want to use qualitative focus group interviews to investigate the participants' attitudes and
      acceptability of the proposed intervention.

      The results of the effect- and process evaluations will be synthesized and will, depending on
      the results of the feasibility study, be implemented in a following planning of a large RCT.

      Qualitative analytical methods The interview guide will be developed based on a literature
      search of existing literature in the field. To minimize the bias of my own influence I will
      consider my own experience and pre-understanding as a midwife.

      The interviews will be recorded digitally and subsequently transcribed literally. The data
      will be analyzed using content analysis as described by Graneheim & Lundman. The purpose of
      the content analysis is to organize and understand the meaning of the data collected in the
      focus group interviews and to draw conclusions from it.

      Statistical analysis The clinical outcomes will be examined using paired t-tests as well as
      linear or logistic regression analyses. Analyses will be done crude and adjusted for
      potential confounders obtained from the completed questionnaires. Results of the analyses of
      the clinical outcomes are expected to be underpowered due to the feasibility design of this
      study but will however provide estimates indicating any direction or effect size of the
      resilience program on this target group.
    

Intervention name(s): Resilience program
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resilience; Cortisol; Feasibility; Healthy lifestyle; Sleep