Text messaging to help women with overweight or obesity lose weight after childbirth: the intervention adaptation and SMS feasibility RCT

C. McGirr, C. Rooney, Dunla Gallagher, S. Dombrowski, A. Anderson, C. Cardwell, C. Free, P. Hoddinott, V. Holmes, E. McIntosh, Camilla Somers, J. Woodside, I. Young, F. Kee, M. McKinley
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McKinley","doi":"10.3310/phr08040","DOIUrl":null,"url":null,"abstract":"Background: \nThere is a need to develop weight management interventions that fit seamlessly into the busy lives of women during the postpartum period. \n \nObjective: \nThe objective was to develop and pilot-test an evidence- and theory-based intervention, delivered by short message service, which supported weight loss and weight loss maintenance in the postpartum period. \n \nDesign: \nStage 1 involved the development of a library of short message service messages to support weight loss and weight loss maintenance, with personal and public involvement, focusing on diet and physical activity with embedded behaviour change techniques, and the programming of a short message service platform to allow fully automated intervention delivery. Stage 2 comprised a 12-month, single-centre, two-arm, pilot, randomised controlled trial with an active control. \n \nSetting: \nThis study was set in Northern Ireland; women were recruited via community-based approaches. \n \nParticipants: \nA total of 100 women with overweight or obesity who had given birth in the previous 24 months were recruited. \n \nInterventions: \nThe intervention group received an automated short message service intervention about weight loss and weight loss maintenance for 12 months. The active control group received automated short message service messages about child health and development for 12 months. \n \nMain outcome measures: \nThe main outcomes measured were the feasibility of recruitment and retention, acceptability of the intervention and trial procedures, and evidence of positive indicative effects on weight. Weight, waist circumference and blood pressure were measured by the researchers; participants completed a questionnaire booklet and wore a sealed pedometer for 7 days at baseline, 3, 6, 9 and 12 months. Outcome assessments were collected during home visits and women received a voucher on completion of each of the assessments. Qualitative interviews were conducted with women at 3 and 12 months, to gather feedback on the intervention and active control and the study procedures. Quantitative and qualitative data were used to inform the process evaluation and to assess fidelity, acceptability, dose, reach, recruitment, retention, contamination and context. \n \nResults: \nThe recruitment target of 100 participants was achieved (intervention, n = 51; control, n = 49); the mean age was 32.5 years (standard deviation 4.3 years); 28 (28%) participants had a household income of < £29,999 per annum. Fifteen women became pregnant during the follow-up (intervention, n = 9; control, n = 6) and withdrew from the study for this reason. At the end of the 12-month study, the majority of women remained in the study [85.7% (36/42) in the intervention group and 90.7% (39/43) in the active control group]. The research procedures were well accepted by women. Both groups indicated a high level of satisfaction with the short message service intervention that they were receiving. There was evidence to suggest that the intervention may have a positive effect on weight loss and prevention of weight gain during the postpartum period. \n \nLimitations: \nThe interviews at 3 and 12 months were conducted by the same researchers who collected other outcome data. \n \nConclusions: \nAn evidence- and theory-based intervention delivered by short message service was successfully developed in conjunction with postpartum women with overweight and obesity. The intervention was acceptable to women and was feasible to implement in the 12-month pilot randomised controlled trial. The progression criteria for a full randomised controlled trial to examine effectiveness and cost-effectiveness were met. \n \nFuture work: \nSome minor refinements need to be made to the intervention and trial procedures based on the findings of the pilot trial in preparation for conducting a full randomised controlled trial. \n \nTrial registration: \nCurrent Controlled Trial ISRCTN90393571. \n \nFunding: \nThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 4. See the NIHR Journals Library website for further project information. The intervention costs were provided by the Public Health Agency, Northern Ireland.","PeriodicalId":32306,"journal":{"name":"Public Health Research","volume":"8 1","pages":"1-152"},"PeriodicalIF":0.0000,"publicationDate":"2020-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"5","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Public Health Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3310/phr08040","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 5

Abstract

Background: There is a need to develop weight management interventions that fit seamlessly into the busy lives of women during the postpartum period. Objective: The objective was to develop and pilot-test an evidence- and theory-based intervention, delivered by short message service, which supported weight loss and weight loss maintenance in the postpartum period. Design: Stage 1 involved the development of a library of short message service messages to support weight loss and weight loss maintenance, with personal and public involvement, focusing on diet and physical activity with embedded behaviour change techniques, and the programming of a short message service platform to allow fully automated intervention delivery. Stage 2 comprised a 12-month, single-centre, two-arm, pilot, randomised controlled trial with an active control. Setting: This study was set in Northern Ireland; women were recruited via community-based approaches. Participants: A total of 100 women with overweight or obesity who had given birth in the previous 24 months were recruited. Interventions: The intervention group received an automated short message service intervention about weight loss and weight loss maintenance for 12 months. The active control group received automated short message service messages about child health and development for 12 months. Main outcome measures: The main outcomes measured were the feasibility of recruitment and retention, acceptability of the intervention and trial procedures, and evidence of positive indicative effects on weight. Weight, waist circumference and blood pressure were measured by the researchers; participants completed a questionnaire booklet and wore a sealed pedometer for 7 days at baseline, 3, 6, 9 and 12 months. Outcome assessments were collected during home visits and women received a voucher on completion of each of the assessments. Qualitative interviews were conducted with women at 3 and 12 months, to gather feedback on the intervention and active control and the study procedures. Quantitative and qualitative data were used to inform the process evaluation and to assess fidelity, acceptability, dose, reach, recruitment, retention, contamination and context. Results: The recruitment target of 100 participants was achieved (intervention, n = 51; control, n = 49); the mean age was 32.5 years (standard deviation 4.3 years); 28 (28%) participants had a household income of < £29,999 per annum. Fifteen women became pregnant during the follow-up (intervention, n = 9; control, n = 6) and withdrew from the study for this reason. At the end of the 12-month study, the majority of women remained in the study [85.7% (36/42) in the intervention group and 90.7% (39/43) in the active control group]. The research procedures were well accepted by women. Both groups indicated a high level of satisfaction with the short message service intervention that they were receiving. There was evidence to suggest that the intervention may have a positive effect on weight loss and prevention of weight gain during the postpartum period. Limitations: The interviews at 3 and 12 months were conducted by the same researchers who collected other outcome data. Conclusions: An evidence- and theory-based intervention delivered by short message service was successfully developed in conjunction with postpartum women with overweight and obesity. The intervention was acceptable to women and was feasible to implement in the 12-month pilot randomised controlled trial. The progression criteria for a full randomised controlled trial to examine effectiveness and cost-effectiveness were met. Future work: Some minor refinements need to be made to the intervention and trial procedures based on the findings of the pilot trial in preparation for conducting a full randomised controlled trial. Trial registration: Current Controlled Trial ISRCTN90393571. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 4. See the NIHR Journals Library website for further project information. The intervention costs were provided by the Public Health Agency, Northern Ireland.
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短信帮助超重或肥胖妇女产后减肥:干预适应与短信可行性RCT
背景:有必要开发体重管理干预措施,以无缝适应产后妇女忙碌的生活。目的:目的是开发和试点一种基于证据和理论的干预措施,通过短信服务提供,支持产后减肥和减肥维持。设计:第一阶段包括开发一个支持减肥和维持减肥的短信服务消息库,个人和公众都参与其中,重点关注饮食和身体活动,并采用嵌入式行为改变技术,以及编写一个短信服务平台,允许完全自动化的干预交付。第二阶段包括一项为期12个月的单中心、双臂、先导、随机对照试验。环境:本研究设置在北爱尔兰;妇女是通过以社区为基础的方法招募的。参与者:总共招募了100名超重或肥胖的女性,她们在过去的24个月内生过孩子。干预措施:干预组接受为期12个月的关于减肥和维持减肥的自动短信服务干预。主动控制组在12个月内收到有关儿童健康和发展的自动短信服务信息。主要结果测量:测量的主要结果是招募和保留的可行性,干预和试验程序的可接受性,以及对体重的积极指示性影响的证据。研究人员测量了他们的体重、腰围和血压;参与者完成一份问卷小册子,并在基线、3、6、9和12个月时佩戴密封计步器7天。结果评估是在家访期间收集的,妇女在完成每次评估后收到一张代金券。在3个月和12个月时对妇女进行定性访谈,以收集有关干预和主动控制以及研究程序的反馈。定量和定性数据用于过程评估,并评估保真度、可接受性、剂量、覆盖范围、招募、保留、污染和环境。结果:达到100名受试者的招募目标(干预,n = 51;对照组,n = 49);平均年龄32.5岁(标准差4.3岁);28名(28%)参与者的家庭年收入低于29,999英镑。15名妇女在随访期间怀孕(干预,n = 9;对照,n = 6),并因此退出研究。在12个月的研究结束时,大多数女性仍在研究中[干预组为85.7%(36/42),积极对照组为90.7%(39/43)]。研究程序得到了妇女的广泛接受。两组人都对他们收到的短信服务干预表示高度满意。有证据表明,干预可能对产后体重减轻和预防体重增加有积极作用。局限性:3个月和12个月的访谈是由收集其他结果数据的同一研究人员进行的。结论:一种基于证据和理论的短信服务干预方法成功地应用于产后超重和肥胖妇女。在为期12个月的随机对照试验中,该干预措施对女性是可接受的,并且是可行的。完全随机对照试验的进展标准以检查有效性和成本效益。未来的工作:需要在试点试验的基础上对干预和试验程序进行一些小的改进,为进行完全随机对照试验做准备。试验注册:当前对照试验ISRCTN90393571。资助:该项目由国家卫生研究所(NIHR)公共卫生研究方案资助,将全文发表在《公共卫生研究》上;第8卷第4期请参阅NIHR期刊图书馆网站了解更多项目信息。干预费用由北爱尔兰公共卫生局提供。
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审稿时长
46 weeks
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