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Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

ABSTRACT: Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.ClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).

SUBMITTER: Santos IS

PROVIDER: S-EPMC5010682 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

Santos Ina S IS Bassani Diego G DG Matijasevich Alicia A Halal Camila S CS Del-Ponte Bianca B da Cruz Suélen Henriques SH Anselmi Luciana L Albernaz Elaine E Fernandes Michelle M Tovo-Rodrigues Luciana L Silveira Mariangela F MF Hallal Pedro C PC

BMC psychiatry 20160902 1

<h4>Background</h4>Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.<h4>Methods</h4>The study is a 1:1 parallel group single-blinded ...[more]

PMID: 27590170

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Project description:Infant-parent bedsharing increases the risk of SIDS and other sleep-related deaths. Despite AAP recommendations to avoid bedsharing, public health efforts have been unsuccessful in changing behaviors. African-American infants are more than twice as likely to die from SIDS and other sleep-related deaths, and are also twice as likely to bedshare with their parents. Further, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation, but low self-efficacy with regards to SIDS risk reduction. It is unclear whether messages emphasizing suffocation prevention will decrease bedsharing. To evaluate the impact of specific health messages on African-American parental decisions regarding infant sleep location. We conducted a randomized, controlled trial of African-American mothers of infants. The control group received standard messaging emphasizing AAP-recommended safe sleep practices, including avoidance of bedsharing, for the purposes of SIDS risk reduction. The intervention group received enhanced messaging emphasizing safe sleep practices, including avoidance of bedsharing, for both SIDS risk reduction and suffocation prevention. Participants completed interviews at 2-3 weeks, 2-3 months, and 5-6 months after the infant's birth. 1194 mothers were enrolled in the study, and 637 completed all interviews. Bedsharing, both usually (aOR 1.005 [95 % CI 1.003, 1.006]) and last night (aOR 1.004 [95 % CI 1.002, 1.007]) increased slightly but statistically significantly with infant age (p < 0.001). Receipt of the enhanced message did not impact on sleep location. Maternal belief that bedsharing increased the risk of SIDS or suffocation declined over 6 months (p < 0.001) and did not differ by group assignment. African-American mothers who received an enhanced message about SIDS risk reduction and suffocation prevention were no less likely to bedshare with their infants.Clinical Trials.gov identifier NCT01361880.

Project description:BackgroundWith increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines.MethodsOne hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher's Exact test to assess group differences in guideline adherence at 2 months.ResultsOne hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25-52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28-46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI - 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface.ConclusionsUtilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices.Trial registrationName: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None.

Project description:BackgroundTo achieve informed choice within the framework of reproductive autonomy, family planning programs have begun to adopt user-centered approaches to service provision, which highlight the individual client as the focal point of interaction and key decision maker. However, little is known about how user-centered approaches to family planning, particularly family planning counseling, shape contraceptive preferences and choices.ObjectiveWe conducted a multiarmed randomized controlled trial to identify the causal impact of user-centered approaches to family planning counseling on women's contraceptive decision making in urban Malawi. This study aims to determine how a tailored, preference-driven approach to family planning counseling and the involvement of male partners during the counseling process may contribute to shaping women's contraceptive preferences and choices.MethodsMarried women aged 18-35 years were recruited and randomly assigned to 1 of the 3 intervention arms or a control arm characterized by the following two interventions: an intervention arm in which women were encouraged to invite their husbands to family planning counseling (husband invitation arm) and an intervention arm in which women received targeted, tailored counseling on up to five contraceptive methods (as opposed to up to 13 contraceptive methods) that reflected women's stated preferences for contraceptive methods. Women were randomized into a control arm, T0 (no husband invitation, standard counseling); T1 (husband invitation, standard counseling); T2 (no husband invitation, targeted counseling); and T3 (husband invitation, targeted counseling). Following counseling, all women received a package of family planning services, which included free transportation to a local family planning clinic and financial reimbursement for family planning services. Follow-up surveys were conducted with women 1 month after counseling.ResultsA total of 785 women completed the baseline survey, and 782 eligible respondents were randomized to 1 of the 3 intervention groups or the control group (T1, n=223; T2, n=225; T3, n=228; T0, n=108). Furthermore, 98.1% (767/782) of women were contacted for follow-up. Among the 767 women who were contacted, 95.3% (731/767) completed the follow-up survey. The analysis of the primary outcomes is ongoing and is expected to be completed by the end of 2021.ConclusionsThe results from this trial will fill knowledge gaps on the effectiveness of tailored family planning counseling and male involvement in family planning on women's stated and realized contraceptive preferences. More generally, the study will provide evidence on how user-centered counseling may affect women's willingness to use and continue contraception to realize their contraceptive preferences.Trial registrationAmerican Economics Association's Registry for Randomized Controlled Trials AEARCTR-0004194; https://www.socialscienceregistry.org/trials/4194/history/46808. Registry for International Development Impact Evaluations RIDIE-STUDY-ID-5ce4f42bbc2bf; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=823.International registered report identifier (irrid)DERR1-10.2196/24884.

Project description:INTRODUCTION:Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice. METHODS AND ANALYSIS:In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4?weekly sessions; total therapy time is approximately 1?hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6?months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. ETHICS AND DISSEMINATION:Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder. TRIAL REGISTRATION NUMBER:ISRCTN42499563.

Project description:BackgroundSleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia.MethodsThis is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis.DiscussionThis research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial.Trial registrationClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

Project description:The current state of knowledge related to diet in Hashimoto thyroiditis (HT) is far from satisfactory, as many HT subjects experience several disorders and report reduced quality of life. There are three aims of the study: (1) to develop a qualitative dietary protocol (QDP; 'Diet4Hashi') as a simple, graphic-text tool dedicated to TH subjects, (2) to evaluate the use of the QDP in dietetic counseling compared to conventional dietetic counseling (CDC) in HT women, and (3) to assess the impact of both the QDP and the CDC on the diet quality, quality of life, adiposity, and metabolic parameters of HT women. The QDP is based on subject self-monitoring supported with a graphic-text tool to help them in food selection and adequate food frequency consumption, while the CDC on oral explanation and printed sample menus were provided by a dietician. The QDP contains two lists: (A) foods recommended for consumption and (B) foods with limited consumption, along with indicated consumption frequency per day/week/month. Both approaches include the same dietary recommendations for HT extracted from the literature but differ in subject-dietician cooperation. To summarize the evidence regarding dietary recommendations in HT, the PubMed, Embase, and Cochrane Library databases (to March 2019) and the bibliographies of key articles were searched. The study is designed as a dietary intervention lasting six months in two parallel groups: experimental and control. In the experimental group, the QDP will be applied, while in the control group, the CDC will be applied. In total, the study will include a baseline of 100 women with diagnosed HT. The subjects will be randomly allocated into the experimental/control groups (50/50). Data related to diet quality and other lifestyle factors, nutrition knowledge, quality of life, thyroid function, body composition, blood pressure, serum fasting glucose, and lipid profile at baseline and after a six-month follow-up will be collected. This study was conducted to develop a dietary protocol (Diet4Hashi) that is easy to follow for HT subjects, and it will contribute to providing valuable data that are useful to dieticians and physicians. It is anticipated that this graphic-text qualitative dietary protocol, by improving food selection and diet quality, may reduce adiposity and improve metabolic parameters and the quality of life of HT women.

Project description:BACKGROUND:Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). METHODS/DESIGN:The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. DISCUSSION:This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

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Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

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Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

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