Women Lift Safely! An Intervention Study to Reduce the Risks of Heavy Lifting
Condition: Behavior, Health; Behavior, Maternal; Work Related Stress
MeSH terms: Pelvic Organ Prolapse; Occupational Stress
Study type: Interventional

Summary: 
      The Women Lift Safely! Intervention study aims to increase safe carrying behavior to reduce
      health risks of heavy lifting in a rural area of Nepal (i.e. reducing weight and using safe
      lifting techniques).

      The study's specific aims are to:

      1) Test whether a psychological intervention that promotes self-efficacy can promote women's
      use of safe carrying behavior effectively compared to an information only control condition.

      (2) Test whether including a social partner in the intervention is more effective than an
      individual psychological intervention.
    

Detailed description: 
      Background

      The frequent carrying of heavy loads bears health risks for women in low- and middle-income
      countries, such as Nepal (Geere et al. 2018,2020; Koyucu et al., 2021; Walker & Gunasekera,
      2011).

      To prevent the physical health impacts of carrying heavy loads, e.g. pelvic organ prolapse,
      research has shown that preventive behaviors in terms of applying safe carrying behaviors can
      enable women to minimize adverse health outcomes:

        1. Reducing the carried load, especially during pregnancy and postpartum (Darshan, 2009;
           Koyucu et al., 2021; MacDonald et al., 2013; Oxford University Hospitals, 2016; Sharma,
           2012; SUVA, the Swiss National Accident Insurance Fund, 2019)

        2. Using safe lifting techniques (exhale, tighten pelvic floor and use a safe body posture
           when lifting load) (Caagbay et al., 2020; Hagins et al., 2004)

      In a preliminary study, the investigators identified low self-efficacy (belief in the own
      capability to engage in healthy behavior) and insufficient social support (emotional,
      practical or informational assistance by social partner) as reasons for risky carrying
      behavior (Tomberge et al., 2021).

      Study design

      A 3-arm parallel non-randomized controlled trial will be conducted in three rural villages in
      the Kavre and Sindhupalanchowk districts of Nepal. The villages will be randomly assigned to
      one of the three groups: (1) individual promotion of self-efficacy, (2) promotion of
      self-efficacy + social support (3) active control group to test the effect of promoting
      self-efficacy and the additional effect of social support on safe carrying behavior against
      an information only control group. The latter, in the sense of a waiting list control group,
      will receive the most effective intervention after completing the study. The assignment of
      groups to the villages will be random (drawing lots by a person not included in the research
      team). All participants from one village will receive the same intervention. This
      village-based allocation of interventions prevents the transfer of information within the
      village (spillover effect, Benjamin-Chung et al., 2018).

      Recruitment and informed consent procedure:

      The villages included were already part of the prestudy in 2019. 100 women from each of the
      three villages and a self-selected social partner from the same or neighboring household
      (e.g. husband, mother-in-law) having experience in carrying loads will be included (N = 600).
      Households / Participants within the villages will be selected using the random route method
      (Hoffmeyer-Zlotnik, 2003). Due to their acute vulnerability, women who are pregnant or who
      have delivered in the last month will be approached specifically.

      Arriving at the households, trained local research assistants will present themselves and
      briefly inform about the study purpose and procedures in Nepali language. The respondents
      willing to participate will be provided with more detailed explanation of the study both
      verbally and with participant information sheets. Respondents will also be provided with
      information and consent forms written in easy language and will be informed that the
      participation will be voluntary.

      Since all the participants will be interviewed in personal communication with enumerators
      with a professional background in health science the informed consent will be fully read out
      to the participants and can be explained more deeply in case of any dubiety. After explaining
      the content of the study the participant will ask the woman if she and also a self-selected
      social partner are willing to participate in the study. If the women and the social partner
      agree and all their doubts and questions are answered, they will be requested to sign the
      informed consent sheet either by signature or thumbprint.

      Study procedure:

      Training: Before the beginning of the study, the local team (practitioners graduated in
      nursing sciences or physiotherapy and research assistants graduated in health/social
      Sciences) will be trained in interviewing techniques and data collection tools. Additionally,
      a pelvic physiotherapist will train them in instructing and assessing safe lifting
      techniques.

      The training will last one week, 2 pretests in villages not part of the analyses included.

      Baseline Survey and Intervention:

      The research assistants will conduct baseline interviews in one village. They will collect
      quantitative data in computer-assisted, structured face-to-face interviews with women and
      their social partners and conduct structured behavioral observations of the women while
      carrying a water-filled container. A local field coordinator will monitor the quality of data
      during the data collection during fieldwork to reduce interviewer bias.

      After the baseline interview, the households will be visited again by the health
      practitioners in order to receive one of the three interventions to promote safe carrying
      behaviors (information only control, individual promotion of self-efficacy, promotion of
      self-efficacy + social support) for which the study participants will be blinded. The study
      team cannot be blinded to condition, but the specific intervention assignment is concealed
      until the arrival at the intervention site. The intervention will be delivered via household
      visits.

      Follow-Up:

      The follow-up survey to test intervention effects will be conducted 8 weeks after baseline.
      In a debriefing after the follow up survey, the allocated intervention group will be revealed
      to the participants.

      Hypotheses:

      The main research questions and hypotheses of this study are:

        1. Does the promotion of self-efficacy lead to more safe carrying behavior in women?

           H1a: Women in the two intervention groups with self-efficacy promotion indicate
           increased reduction of carried weight compared to the control group.

           H1b: Women in the two intervention groups with self-efficacy promotion indicate
           increased use of safe lifting techniques compared to the control group.

        2. Can adding social support by a social partner increase safe carrying behavior
           additionally?

           H2a: Women in the group with self-efficacy + social support indicate increased reduction
           of carried weight compared to the group with individual self-efficacy promotion.

           H2b: Women in the group with self-efficacy + social support indicate increased use of
           safe lifting techniques compared to the group with individual self-efficacy promotion.

        3. Can the intervention effects on safe carrying behavior be explained by increased
           self-efficacy?

           H3a: The intervention effect on carried weight of the two intervention groups with
           self-efficacy promotion compared to controls is explained by increased self-efficacy.

           H3b: The intervention effect on the use of safe lifting techniques in the two
           intervention groups with self-efficacy promotion compared to controls is explained by
           increased self-efficacy.

           H3c: The increased reduction of carried weight of the group self-efficacy + social
           support compared to the group with individual self-efficacy promotion is explained by
           increased self-efficacy.

           H3d: The increased use of safe lifting techniques in the group self-efficacy + social
           support compared to the group with individual self-efficacy promotion is explained by
           increased self-efficacy.

        4. Can the intervention effects be explained by increased received social support? H4a: The
           increased reduction of carried weight of the group self-efficacy + social support
           compared to the group with individual self-efficacy promotion is explained by increased
           social support.

           H4b: The increased use of safe lifting techniques in the group self-efficacy + social
           support compared to the group with individual self-efficacy promotion is explained by
           increased social support.

           H4c: The increased self-efficacy in the group self-efficacy + social support compared to
           the group with individual self-efficacy promotion is explained by increased received
           social support.

           Additionally, the investigators will investigate the following exploratory research
           questions:

        5. Can the interventions increase women's self-efficacy and intention to reduce carried
           weight in future pregnancies and postpartum?

        6. Is the reduction of carried weight related to an increased carrying frequency?

        7. Does the intervention have an impact on other psychosocial determinants of carrying
           behavior?

        8. Can the interventions improve women's quality of life, and reduce strain during lifting,
           pain, symptoms of incontinence and pelvic organ prolapse, and perceived personal control
           over symptoms?

        9. Do the interventions have an impact on relationship quality with the social partner and/
           or the social partners' behavior and attitudes towards safe carrying behavior?

      Statistics:

      An a priori power analysis with a desired power of > 95%, a significance level of α = 0.05
      and the assumption of medium effects (based on a study by Ernsting et al.,(2015)) resulted in
      a required sample size of N = 251 to detect a significant difference between the three groups
      when using repeated-measures ANCOVA (Faul et al., 2009). This analysis is based on including
      six covariates (Outcome at baseline, age, socioeconomic status, ethnicity, education and
      pregnancy status). Due to an expected dropout rate of up to 20% from baseline to follow-up
      (Wood et al., 2004) we will recruit 100 women in each of the three villages.

      Planned analyses:

      Summary of descriptive statistics

      All primary and secondary outcomes will be presented. For the evaluation of the intervention
      effects, repeated measures covariance analyses (ANCOVA) with the two measurement points (pre/
      post) will be calculated using the intervention groups as independent variables and reduced
      weight and use of safe lifting techniques as well as self-efficacy and social support as
      dependent variables. Further secondary outcomes, e.g. effects of the intervention on
      psychological wellbeing and physical health symptoms, will be calculated additionally.

      Mediation analyses will be carried out for self-efficacy and social support as mediators.

      Research Team:

      Jennifer Inauen & Vica Tomberge (University of Bern, Institute of Psychology, Health
      Psychology and Behavioural Medicine), Akina Shrestha (Kathmandu University Hospital;
      Kathmandu University School of Medical Sciences), Regula Meierhofer (Eawag, Swiss Federal
      Institute of Aquatic Science and Technology; Department of Sanitation, Water and Solid Waste
      for Development), Helena Luginbühl (Bern University of Applied Sciences, Department of Health
      Professions, Division of Physiotherapy)
    

Intervention name(s): Information about benefits of the behavior; Instruction on how to perform a behavior; Self-efficacy; Social Support
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The women will be informed that the safe carrying behaviors can reduce pelvic strain. She is informed about the benefits reducing pelvic strain may imply [5.1; 5.3.,5.6 Information about health; environmental; social; and emotional consequences, (Michie et al., 2013)]; For the target behavior "reduce carried weight" information on recommended weight limits will be given. The women will be encouraged, that even if these limits may not be feasible for them, any reduction of weight can still reduce the strain on the pelvic floor.
For the target behavior "safe lifting techniques", instructions to learn the correct behavior (how to perform safe lifting techniques?) based on leaflets developed and validated by Caagbay et al., (2017, 2020) [4.1 Instruction on how to perform a behavior (Michie et al., 2013)]; Self-efficacy will be promoted by the four sources of self-efficacy (Bandura, 1977): 1) Mastery Experiences (experience that one is able to successfully apply the behavior), vicarious experience (observing successful others performing the safe carrying behavior), verbal persuasion (receiving positive feedback when performing the behavior and encouraging messages to do so) and emotional state (e.g. being in a positive emotional state when performing the behavior). [6.1 Demonstration of the behavior; 8.1 Behavioral practice/rehearsal; 15.1 Verbal persuasion about capability; 15.2 Mental rehearsal of successful performance; 15.3 Focus on past success;15.4 Self-talk; 5.4 Monitoring of emotional consequences (Michie et al., 2013)]; A self-selected social partner from the same or neighboring household (e.g. husband, mother-in-law) will be involved in the learning process (observational learning, feedback). The partner will participate in the intervention activities and will be instructed to provide emotional social support and practical informational support. [3.2 practical support, 3.3 emotional support; 6.3 Information about others' approval (Michie et al., 2013).]
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 3-arm parallel non-randomized controlled trial
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pelvic organ prolapse; Self-efficacy; Social support; Health behavior change