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MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial.

ABSTRACT: Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia.A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes, and these will be estimated with 95% confidence intervals. All analyses will be based on the 'intention to treat' principle.This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy. Findings could be generalisable to similar populations in different settings.ClinicalTrials.gov Identifier: NCT01823861.

SUBMITTER: Smith C

PROVIDER: S-EPMC4029778 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial.

Smith Chris C Vannak Uk U Sokhey Ly L Ngo Thoai D TD Gold Judy J Khut Khemrin K Edwards Phil P Rathavy Tung T Free Caroline C

Trials 20131212

<h4>Background</h4>Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia.<h4>Methods/design</h4>A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at fo ...[more]

PMID: 24330763

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Project description:Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia and compare how the result might have varied using different analytical methods.Follow-up in the MOTIF trial was 86% at 4 months and 66% at 12 months. For the primary analysis, we undertook a complete case analysis, similar to the approach used in similar trials of interventions delivered by mobile phone to increase contraception use. We conducted an exploratory analysis and found that factors associated with LTFU were young age, lower socio-economic status, not planning to use post-abortion contraception, availability of phone credit and not providing additional contact numbers. We then undertook two analyses to estimate the effect of the intervention on the primary outcome at 4 and 12 months for comparison with the complete case analysis. First, we undertook multiple imputation, and second we conducted an analysis treating all participants' LTFU as non-users of contraception.Using multiple imputation, we found that the risk ratio was slightly increased at 4 months and slightly decreased at 12 months compared with the complete case analysis. When counting all participants' LTFU as non-users of contraception, we observed that, compared with the complete case analysis, the risk ratio was slightly decreased at 4 months and slightly increased at 12 months. Despite the changes in the risk ratio, use of the different analytical methods did not result in an effect using the complete case analysis becoming statistically significant or vice versa.Future studies assessing contraception use might anticipate increased attrition amongst younger participants, those of lower socio-economic status or those who do not provide additional contact details. Attrition could be reduced by collecting as many contact details as possible, by providing incentives and possibly by enhanced counselling to groups at higher risk of LTFU on recruitment. Multiple imputation should be considered in addition to complete case analysis if LTFU not missing at random is expected or observed.ClinicalTrials.gov, NCT01823861 . Registered on 30 March 2013.

Project description:BackgroundA variety of different approaches to measuring contraceptive use have been used or proposed, either to assess current use or adherence over time, using subjective or objective measures. This paper reports an overview of approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable and describes how we assessed contraception use in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia.Main bodyWe summarise and discuss advantages and disadvantages of different subjective and objective approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable such as self-reports, clinic records, electronic monitoring devices, clinical examination and biomarkers. For the MOTIF trial, we did not consider it feasible to measure objective contraception use as many participants lived a long distance from the clinic and we were concerned whether it was appropriate to ask women to return to clinic for a physical examination simply to verify self-report information already provided. We aimed to assess the validity of the four-month data with 50 participants, calculating the sensitivity and specificity of self-reported data compared with objective measurement. For the 46 valid measurements obtained, the sensitivity and specificity was 100% for self-reported contraception use compared to objective measurement but this study had some limitations. To assess reliability of self-report data we compared calendar data collected on effective contraception use at months 1-4 post-abortion, collected separately at four and 12 months. Agreement ranged from 80 to 84% with a kappa statistic ranging from 0·59 to 0·67 indicating fair to good agreement.ConclusionThere is no perfect method of assessing contraception use and researchers designing future studies should give consideration of what to measure, for example current use or detailed patterns of use over time, and remain mindful of what will be feasible and acceptable to the study population. Although self-reported data on contraception use are considered less reliable, and prone to social desirability bias, it is often the standard approach for contraception research and provides data comparable to previous studies.Trial registrationClinicalTrials.gov Identifier: NCT01823861 . Registered: March 30, 2013.

Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

Project description:BACKGROUND:The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. OBJECTIVE:This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. METHODS:Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. RESULTS:A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. CONCLUSIONS:The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women's well-being. TRIAL REGISTRATION:American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16697.

Project description:The primary objective of this study was to test the effectiveness of integrating family planning service components into infant immunization services to increase modern contraceptive method use among postpartum women.The study was a separate sample, parallel, cluster-randomized controlled trial. Fourteen randomly selected primary health facilities were equally allocated to intervention (integrated family planning and immunization services at the same time and location) and control groups (standard immunization services only). At baseline (May-June 2010), we interviewed postpartum women attending immunization services for their infant aged 6 to 12 months using a structured questionnaire. A separate sample of postpartum women was interviewed 16 months later after implementation of the experimental health service intervention. We used linear mixed regression models to test the study hypothesis that postpartum women attending immunization services for their infants aged 6-12 months in the intervention facilities will be more likely to use a modern contraceptive method than postpartum women attending immunization services for their infants aged 6-12 months in control group facilities.We interviewed and analyzed data for 825 women from the intervention group and 829 women from the control group. Results showed the intervention had a statistically significant, positive effect on modern contraceptive method use among intervention group participants compared with control group participants (regression coefficient, 0.15; 90% confidence interval [CI], 0.04 to 0.26). Although we conducted a 1-sided significance test, this effect was also significant at the 2-sided test with alpha?=?.05. Among those women who did not initiate a contraceptive method, awaiting the return of menses was the most common reason cited for non-use of a method. Women in both study groups overwhelmingly supported the concept of integrating family planning service components into infant immunization services (97.9% in each group), and service data collected during the intervention period did not indicate that the intervention had any negative effect on infant immunization service uptake.Integrating family planning service components into infant immunization services can be an acceptable and effective strategy to increase contraceptive use among postpartum women. Additional research is needed to examine the extent to which this integration strategy can be replicated in other health care settings. Future research should also explore persistent misconceptions regarding the relationship between return of menses and return to fertility during the postpartum period.

Project description:Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines.A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families.This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families.This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192.

Project description:BACKGROUND:Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. METHODS/DESIGN:We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. DISCUSSION:To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care. TRIAL REGISTRATION:ISRCTN34966555. Date of first registration: 12 June 2014.

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MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial.

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MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial.

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