Clinical trial NCT05154006: Women Lift Safely! An Intervention Study to Reduce the Risks of Heavy Lifting
Official title: Promoting Self-efficacy and Social Support to Enable Women to Reduce the Risks of Pelvic Organ Prolapse Related to Heavy Lifting in a Non-randomized Controlled Trial With a 3-arm Parallel Intervention Group Design in Rural Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Behavior, Maternal
Work Related Stress
Keywords: Pelvic organ prolapse
Self-efficacy
Social support
Health behavior change
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Suzanne und Hans Biäsch Foundation
First posted: 2021-12-10
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm parallel non-randomized controlled trial
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: Inclusion criteria:

* Written informed consent
* Gender: female
* Being adult and in reproductive age (18-49 years)
* Having experience in carrying loads
* Having a social partner with experience in carrying loads
* Residing in the targeted community

Exclusion criteria:

* If the women themselves or a household member presents covid symptoms they need to be excluded to avoid any risk of contamination of the research team.
* Women without a possible social partner will be excluded from the survey since this intervention is designed to include support of a social partner. They will receive the information only control intervention for ethical reasons when approached as a household in random selection.

Primary outcomes:
measure: Self-reported carried weight at follow up
timeFrame: 8 weeks after intervention
measure: Index of self-reported safe lifting techniques during performance at follow up
timeFrame: 8 weeks after intervention
Secondary outcomes:
measure: Observed safe lifting techniques during performance
timeFrame: 8 weeks after intervention
measure: Self-reported perception and use of pelvic floor muscles during lifting through open questions
timeFrame: 8 weeks after intervention
measure: Self-reported self-efficacy to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported self-efficacy to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported received social support to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported received social support to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported carrying frequency per week
timeFrame: 8 weeks after intervention
measure: Self-reported self-efficacy to reduce carried weight during prospective pregnancies / postpartum
timeFrame: 8 weeks after intervention
measure: Self-reported weight intended to carry during prospective pregnancies / postpartum
timeFrame: 8 weeks after intervention
measure: Self-reported risk perception to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported risk perception to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported outcome expectancies to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported outcome expectancies to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported intention to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported intention to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported action planning to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported action planning to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported coping planning to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported coping planning to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Self-reported perceived barriers to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Self-reported perceived barriers to use safe lifting techniques
timeFrame: 8 weeks after intervention
measure: Additional self-reported psychosocial determinants to reduce carried weight
timeFrame: 8 weeks after intervention
measure: Additional self-reported psychosocial determinants of using safe lifting techniques.
timeFrame: 8 weeks after intervention
measure: Self-reported knowledge on safe carrying behaviors
timeFrame: 8 weeks after intervention
measure: Self-reported knowledge on tightening pelvic floor
timeFrame: 8 weeks after intervention
measure: Self-reported pain
timeFrame: 8 weeks after intervention
measure: Self-reported strain during lifting
timeFrame: 8 weeks after intervention
measure: Self-reported symptoms of pelvic organ prolapse
timeFrame: 8 weeks after intervention
measure: Self-reported symptoms of incontinence
timeFrame: 8 weeks after intervention
measure: Self-reported quality of life
timeFrame: 8 weeks after intervention
measure: Self-reported illness-related personal control
timeFrame: 8 weeks after intervention
measure: Self-reported daily functioning
timeFrame: 8 weeks after intervention
measure: Self-reported quality of relationships
timeFrame: 8 weeks after intervention
Other outcomes:
Locations:
city: Kavre
country: Nepal
facility: Outreach Centers of Dhulikhel Hospital, Kathmandu University School of Medical Sciences
state: Kavre District
city: Sindhupalchok
country: Nepal
facility: Outreach Centers of Dhulikhel Hospital, Kathmandu University School of Medical Sciences
Study officials:
affiliation: University of Bern, Health Psychology & Behavioral Medicine
name: Jennifer Inauen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dhulikhel Hospital, Kathmandu University School of Medical Sciences
name: Akina Shrestha, PhD
role: PRINCIPAL_INVESTIGATOR
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