CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Information about benefits of the behavior +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05154006
NCT05154006N/ACompleted

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

University of Bern·interventional·Posted Dec 10, 2021·Updated Sep 13, 2023

In Brief

A clinical study evaluating Information about benefits of the behavior, Instruction on how to perform a behavior, and 2 other interventions for Behavior, Health and 2 related conditions. Completed, enrolled 600 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNepal

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 10, 2021
Enrollment StartJan 14, 2022
Primary CompletionApr 2, 2022
Study CompletionOct 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.6 years ago

Interventions

Information about benefits of the behaviorbehavioral

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

Instruction on how to perform a behaviorbehavioral

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-efficacybehavioral

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

Social Supportbehavioral

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