Women Lift Safely! An Intervention Study to Reduce the Risks of Heavy Lifting

NCT05154006 | Completed DMC

• 1 other identifier: 41487
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavior, Health; Behavior, Maternal; Work Related Stress

Keywords

Pelvic organ prolapse; Self-efficacy; Social support; Health behavior change

Outcome Measures

Primary Outcomes (2)

• Self-reported carried weight at follow up

  Carried weight will be assessed through the sum of two self-reported items referring to the weight carried in the last week. Open answers in kg. "In the last 7 days, what was the usual weight of water you carried per trip?" "In the last 7 days, what was the usual weight of other loads (e.g. grass, fodder, firewood you carried per trip?"

  8 weeks after intervention

• Index of self-reported safe lifting techniques during performance at follow up

  An index of safe lifting will be calculated by the product of a safe lifting score x self-reported frequency of using safe-lifting techniques, ranging from 0 (= never uses safe lifting techniques) to 7 (= always uses safe lifting techniques) Score: The participants will be asked to lift a water-filled container at the size they usually carry. Lifting techniques will then be assessed through two self-reported items, e.g.: "What did you do with your pelvic floor during lifting?" 1 = "Tightening"; 0 "Relax"; 0 "did not feel the pelvic floor"; 0 = "I don't know"; 0 = "other". The safe lifting score is calculated by summing the points of the two items, thus ranging from 0 (= unsafe lifting) to 2 (= safe lifting). Frequency: Average of two items "In the last 7 days, how often did you tighten your pelvic floor when lifting loads?"; "In the last 7 days, how often did you exhale when lifting loads?" Answer options 1 = ((Almost) never (0%)) to 5 (= (Almost) always (100%)).

  8 weeks after intervention

Secondary Outcomes (33)

• Observed safe lifting techniques during performance

  8 weeks after intervention

• Self-reported perception and use of pelvic floor muscles during lifting through open questions

  8 weeks after intervention

• Self-reported self-efficacy to reduce carried weight

  8 weeks after intervention

• Self-reported self-efficacy to use safe lifting techniques

  8 weeks after intervention

• Self-reported received social support to reduce carried weight

  8 weeks after intervention

Study Arms (3)

Active Control (Information only)

ACTIVE COMPARATOR

Women in the active control group receive instruction on safe carrying behaviors (reduce carried weight \& use safe lifting techniques) and information about benefits when performing the behavior and reducing strain on the pelvic floor.

Behavioral: Information about benefits of the behavior; Behavioral: Instruction on how to perform a behavior

Individual promotion of self-efficacy

EXPERIMENTAL

The group "Individual promotion of self-efficacy" receives the same instructions and information on safe carrying behavior as the control group. Additionally, this group will receive behavior change techniques (Michie et al., 2013) to increase self-efficacy (psychological activities to increase self-confidence / belief in own capability to reduce risks of carrying loads with own behavior).

Behavioral: Information about benefits of the behavior; Behavioral: Instruction on how to perform a behavior; Behavioral: Self-efficacy

Promotion of self-efficacy + social support

EXPERIMENTAL

The group "Promotion of self-efficacy + social support" receives the same instructions for safe carrying behavior as the control group. The intervention will also include the same behavior change techniques to promote self-efficacy. Additionally, a social partner from the same or neighboring household will be involved in the intervention activities. The partner will participate in the intervention activities and will be instructed to provide emotional, practical and informational social support.

Behavioral: Information about benefits of the behavior; Behavioral: Instruction on how to perform a behavior; Behavioral: Self-efficacy; Behavioral: Social Support

Interventions

Information about benefits of the behavior BEHAVIORAL

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 \[5.1; 5.3.,5.6 Information about health; environmental; social; and emotional consequences, (Michie et al., 2013)\]

Active Control (Information only); Individual promotion of self-efficacy; Promotion of self-efficacy + social support

Instruction on how to perform a behavior BEHAVIORAL

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) \[4.1 Instruction on how to perform a behavior (Michie et al., 2013)\]

Active Control (Information only); Individual promotion of self-efficacy; Promotion of self-efficacy + social support

Self-efficacy BEHAVIORAL

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). \[6.1 Demonstration of the behavior; 8.1 Behavioral practice/rehearsal; 15.1 Verbal persuasion about capability; 15.2 Mental rehearsal of successful performance; 15.3 Focus on past success;15.4 Self-talk; 5.4 Monitoring of emotional consequences (Michie et al., 2013)\]

Individual promotion of self-efficacy; Promotion of self-efficacy + social support

Social Support BEHAVIORAL

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. \[3.2 practical support, 3.3 emotional support; 6.3 Information about others' approval (Michie et al., 2013).\]

Promotion of self-efficacy + social support

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Sex: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• Suzanne und Hans Biäsch Foundation: collaborator

Study Sites (2)

Outreach Centers of Dhulikhel Hospital, Kathmandu University School of Medical Sciences

Kavre, Kavre District, Nepal

Location

Outreach Centers of Dhulikhel Hospital, Kathmandu University School of Medical Sciences

Sindhupalchok, Nepal

Location

Related Publications (26)

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MeSH Terms

Conditions

Health Behavior; Behavior; Occupational Stress; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Inauen, PhD

  University of Bern, Health Psychology & Behavioral Medicine

  PRINCIPAL INVESTIGATOR

• Akina Shrestha, PhD

  Dhulikhel Hospital, Kathmandu University School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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. Participants are blinded to condition. Enumerators cannot be blinded to condition, but the specific intervention assignment is concealed until the arrival at the intervention site. In a debriefing after the follow up interviews, the allocated intervention group will be revealed to the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-arm parallel non-randomized controlled trial

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 10, 2021
• Study Start: January 14, 2022
• Primary Completion: April 2, 2022
• Study Completion: October 22, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Study information and materials will be uploaded after the pretests. The Analysis Code and Participant data will be uploaded after the acceptance of a publication describing the main outcomes of the interventions.

Locations

NE (2)