A Randomized Controlled Trial of Prenatal Pediatric Visits for Urban, Low-income Families

Background. Prenatal pediatric visits have been recommended by the American Academy of Pediatrics to allow the pediatrician to counsel parents on infant care issues, establish a supportive relationship, and provide pediatric practice information to parents. We hypothesized that prenatal pediatric visits would have an impact on breastfeeding decisions, health care behaviors, health care utilization, and the doctor-patient relationship. Methods. We conducted a randomized controlled trial of prenatal pediatric visits for urban, low-income families to measure the impact on breastfeeding decisions, infant car safety seat use, circumcision, health maintenance, and emergency room visits and the pediatrician's perception that he/she would know the mother better. Pregnant women were recruited prenatally from the obstetrics clinic. Outcomes were measured by maternal interview prenatally and when the infant was 2 months old, in addition to review of the nursery record. Physicians were interviewed after the 2-month visit. Health care utilization was measured by chart review at 7 months. Results. A total of 156 pregnant women were enrolled and randomized, 81 to the intervention group and 75 to the control group. Of mothers who breastfed, 45% in the intervention group changed their mind in favor of breastfeeding after enrollment compared with 14% in the control group. Mothers in the intervention group compared with the control group were more likely to make fewer emergency room visits, 0.58 compared with 1.0. Pediatricians were more likely to think that they knew mothers in the intervention group well, 54% versus 29% in the control group, yet 67% of mothers in both groups agreed their pediatrician knew them well. There were no differences between groups in initiation or duration of breastfeeding at 30 or 60 days, infant car safety seat use, circumcision, or health maintenance visits. Conclusions. Prenatal pediatric visits have potential impact on a variety of health care outcomes. Among urban, low-income mothers, we found beneficial effects on breastfeeding decisions, a decrease in emergency department visits, and an initial impact on the doctor-patient relationship. We suggest urban practices actively promote prenatal pediatric visits.

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Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

BMC Public Health ◽

10.1186/s12889-021-10627-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mariko Nishikawa ◽

Masaaki Yamanaka ◽

Akira Shibanuma ◽

Junko Kiriya ◽

Masamine Jimba

Keyword(s):

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Safety Information ◽

Intervention Group ◽

Health And Safety ◽

Trial Registration ◽

Control Group ◽

Internet Portal ◽

Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

10.21203/rs.3.rs-24814/v1 ◽

2020 ◽

Author(s):

Ameer Muhammad ◽

Yasir Shafiq ◽

M Imran Nisar ◽

Benazir Baloch ◽

Amna Tanweer Yazdani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Relative Length ◽

Trial Registration ◽

Control Group ◽

Lactating Women ◽

Randomized Controlled ◽

Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

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Does a brief work-stress intervention prevent sick-leave during the following 24 months? A randomized controlled trial in Swedish primary care

Work ◽

10.3233/wor-205029 ◽

2021 ◽

pp. 1-10

Author(s):

Jenny Hultqvist ◽

Pernilla Bjerkeli ◽

Gunnel Hensing ◽

Kristina Holmgren

Keyword(s):

Health Care ◽

Primary Health Care ◽

Sick Leave ◽

Early Identification ◽

Controlled Trial ◽

Intervention Group ◽

Training Session ◽

Control Group ◽

Treatment As Usual ◽

Primary Health

BACKGROUND: Work-related stress (WRS) presents a risk for sick leave. However, effective methods to identify people at risk for sick leave due to WRS at an early stage are lacking in primary health care. OBJECTIVE: To evaluate whether a systematic early identification of WRS can prevent sick leave over 24 months after the intervention. METHODS: Study participants (n = 132 intervention; n = 139 control) were employed, non-sick-listed persons seeking care at primary health care centres. The intervention included early identification of WRS by a validated instrument, general practitioner (GP) awareness supported by a brief training session, patients’ self-reflection by instrument completion, GP giving the patient feedback at consultation and GP identifying preventive measures. The control group received treatment as usual. Outcome data were retrieved from the Swedish Social Insurance Agency. RESULTS: The intervention group had less registered median sick leave days (n = 56) than the control group (n = 65) but the difference was not statistically significant. CONCLUSIONS: The brief intervention was not proven effective in preventing sick leave in the following 24 months compared to treatment as usual. Further research on how to identify, advice and treat those at high risk for sick leave in primary health care is needed.

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Abstract P200: Effects Of A 2-year Randomized Controlled Trial Physical Activity Intervention On Accelerometer-measured Sleep Characteristics Among Older Adults In Senior Center Communities

Circulation ◽

10.1161/circ.143.suppl_1.p200 ◽

2021 ◽

Vol 143 (Suppl_1) ◽

Author(s):

Kelsie M Full ◽

Katie Crist ◽

Marta Jankowska ◽

Pamela L Lutsey ◽

Loki Natarajan

Keyword(s):

Physical Activity ◽

Older Adults ◽

Sleep Duration ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Sleep Efficiency ◽

Control Group ◽

Senior Center ◽

Intervention Effect

Background: Targeting daily increases in physical activity (PA) is a common lifestyle strategy for cardiovascular disease (CVD) risk reduction. While less targeted in lifestyle interventions, poor sleep is also consistently linked to CVD. Emerging evidence connects changes in daily PA to beneficial changes in sleep; however, little is known about the impact of community-based PA interventions on habitual sleep among older adults. We leveraged accelerometer data from the Peer Empowerment Program for Physical Activity in Low Income & Minority Seniors (PEP4PA) randomized controlled trial to examine the effect of a PA intervention on accelerometer-measured sleep characteristics among older adults in low income and diverse senior center communities. Methods: PEP4PA participants (N=476; mean age=71.0 ± 9 years, 75% female, 60% low income, 36% non-white) were recruited from senior centers and randomized to a healthy control condition(n=209) or a peer-lead walking intervention (N=267). The peer-led PA intervention included self-monitoring techniques, health coach counseling, group walks, and community advocacy to improve walking conditions. Participants wore Actigraph GT3X+ accelerometers on the wrist at baseline, 6, 12, and 24 months. Data were processed for sleep characteristics including weekly average sleep duration and sleep efficiency. Mixed effects regression models provided estimates of the intervention effect on sleep characteristics at each time point. Models were adjusted for age, sex, and race. Three way interaction terms (time*treatment*sleep duration status) were used to assess differential intervention effects by short (<7) and long (>8 hours) sleep duration status at baseline. Results: At baseline, the average sleep duration of participants was 7 hours (SD: 1.07 hours) and the average sleep efficiency was 87.0% (SD: 6.2%). Compared to participants in the control group, participants in the intervention group had shorter sleep durations (7.1 hours vs 7.0 hours; p value: 0.08) and poorer sleep efficiency 86.0% vs 88.2%; p<0.001) at baseline. At 12 or 24-months, there was no intervention effect on participants’ average sleep duration or efficiency. Although not significant, at 6 months, long sleepers in the intervention group experienced an average 6-minute reduction in sleep duration (-B: 6.25, p=0.45) compared to those in the control group. Conclusions: Over the 2-year period, the PA intervention did not appear to have an impact on participants’ average sleep duration or quality. More investigation is needed into the temporal and daily relations of PA and sleep among older adults in interventions to understand if increases in daily PA are associated with better sleep characteristics at night.

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Do Postpartum Nursery Visits by the Primary Care Provider Make a Difference?

PEDIATRICS ◽

10.1542/peds.88.3.444 ◽

1991 ◽

Vol 88 (3) ◽

pp. 444-449

Author(s):

Janet R. Serwint ◽

Modena H. Wilson ◽

Anne K. Duggan ◽

E. David Mellits ◽

Rosemary A. Baumgardner ◽

...

Keyword(s):

Primary Care ◽

Health Care ◽

Health Care Utilization ◽

Care Provider ◽

Primary Care Provider ◽

Intervention Group ◽

Maternal Anxiety ◽

Care Utilization ◽

Control Group ◽

Maternal Knowledge

A prospective, randomized, clinical trial was conducted to investigate whether a postpartum visit between a mother and her neonate's future primary care provider combined with telephone access would improve health care utilization, enhance identification of the provider as a source of advice, increase maternal knowledge of infant care, and decrease maternal anxiety and depression. Of 251 mother-neonate pairs, 122 were randomized to the control group and 129 to the intervention group. Outcome variables included health care utilization and results of maternal interviews. More mothers in the intervention group made a scheduled clinic visit in the first 30 days (P = .003), were more likely to seek some form of care at the clinic (P = .006), and tried to reach their physician by phone more often than the control group (P <.001). There were no differences between the groups' emergency room utilization, the percent who received immunizations by 90 days of age, maternal knowledge of infant care, maternal anxiety, or postpartum depression. The intervention succeeded in improving some measures of health care utilization and results suggest that the relationship between the mother and clinician was strengthened.

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Diet quality from pre-school to school age in Brazilian children: a 4-year follow-up in a randomised control study

British Journal Of Nutrition ◽

10.1017/s0007114513002857 ◽

2013 ◽

Vol 111 (3) ◽

pp. 499-505 ◽

Cited By ~ 17

Author(s):

Fernanda Rauber ◽

Daniel J. Hoffman ◽

Márcia Regina Vitolo

Keyword(s):

Diet Quality ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Saturated Fat ◽

Healthy Eating Index ◽

Control Group ◽

School Age

A previous study demonstrated that dietary counselling for mothers during the first year of life improved overall diet quality of children at pre-school age in a low-income population. Thus, the objective of the present study was to assess the long-term effect of this intervention on diet quality of children at school age and examine the tracking of dietary intake throughout childhood. The present study was a follow-up of a randomised controlled trial with children who were assessed at 3–4 years (n 345) and 7–8 years (n 307) of age. We collected two 24 h dietary recalls and assessed diet quality using the Healthy Eating Index (HEI). Analyses were performed by group using a paired t test and a Student's t test for independent samples. Diet quality did not differ between the intervention and control groups at 7–8 years of age (HEI score 65·2 (sd 9·5) v. 64·9 (sd 8·5)). Regarding changes in diet quality from pre-school to school age, we observed the tracking of diet quality in the control group and the loss of the intervention effect in the intervention group. In both groups, the score for fruit and milk intake decreased, while that for saturated fat and dietary variety intake increased. The score for the intakes of grains, meat and legumes, and total fat remained constant for all children. The present data provide evidence that diet quality tracks during childhood since the total HEI score did not differ over time in the control group. The decrease in score for some HEI components did not affect the overall diet quality due to the increase in score for other HEI components.

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Evaluation of Parent and Child Enhancement (PACE) Program

Research on Social Work Practice ◽

10.1177/1049731515578882 ◽

2016 ◽

Vol 27 (1) ◽

pp. 19-35 ◽

Cited By ~ 3

Author(s):

Cynthia Leung ◽

Sandra Tsang ◽

Cyrus Lo

Keyword(s):

Behavior Problems ◽

Child Behavior ◽

Low Income ◽

Parental Stress ◽

Controlled Trial ◽

Intervention Group ◽

Child Behavior Problems ◽

Control Group ◽

Child Preschool ◽

Child Learning

Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or single-parent families, and (3) parent–child dyads being Hong Kong residents. Intervention group dyads were offered the PACE program (40 two-hour sessions on child learning and parenting). Primary outcomes included child preschool concepts, child behavior problems, and parental stress. Participants were randomly assigned to intervention (76 dyads) and control group (73 dyads) using a random number table, without blinding. Results: Intention-to-treat analysis with 149 dyads indicated improvement in child preschool concepts, decrease in child behavior problems and parental stress in the intervention group, compared with the control group ( d = 0.12–0.73). Conclusions: The results provided evidence for the efficacy of the PACE program.

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A randomised safety promotion intervention trial among low-income families with toddlers

Injury Prevention ◽

10.1136/injuryprev-2016-042178 ◽

2017 ◽

Vol 24 (1) ◽

pp. 41-47 ◽

Cited By ~ 5

Author(s):

Yan Wang ◽

Andrea C Gielen ◽

Laurence S Magder ◽

Erin R Hager ◽

Maureen M Black

Keyword(s):

Low Income ◽

Intervention Group ◽

Attention Control ◽

Control Group ◽

Home Safety ◽

Safety Promotion ◽

Low Income Families ◽

Attention Control Group ◽

Over Time

BackgroundToddler-aged children are vulnerable to unintentional injuries, especially those in low-income families.ObjectiveTo examine the effectiveness of an intervention grounded in social cognitive theory (SCT) on the reduction of home safety problems among low-income families with toddlers.Methods277 low-income mother–toddler dyads were randomised into a safety promotion intervention (n=91) or an attention-control group (n=186). Mothers in the safety promotion intervention group received an eight-session, group-delivered safety intervention targeting fire prevention, fall prevention, poison control and car seat use, through health education, goal-setting and social support. Data collectors observed participants' homes and completed a nine-item checklist of home safety problems at study enrolment (baseline), 6 and 12 months after baseline. A total score was summed, with high scores indicating more problems. Linear mixed models compared the changes over time in home safety problems between intervention and control groups.ResultsThe intent-to-treat analysis indicated that the safety promotion intervention group significantly reduced safety problems to a greater degree than the attention-control group at the 12-month follow-up (between-group difference in change over time β=−0.54, 95% CI −0.05 to −1.03, p=0.035), with no significant differences at the 6-month follow-up.ConclusionsA safety promotion intervention built on principles of SCT has the potential to promote toddlers' home safety environment. Future studies should examine additional strategies to determine whether better penetration/compliance can produce more clinically important improvement in home safety practices.Trial registration numberNCT02615158; post-results.

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Outcomes of a Weight Loss Intervention to Prevent Diabetes Among Low-Income Residents of East Harlem, New York

Health Education & Behavior ◽

10.1177/1090198119868232 ◽

2019 ◽

Vol 46 (6) ◽

pp. 1073-1082 ◽

Cited By ~ 1

Author(s):

Victoria L. Mayer ◽

Nita Vangeepuram ◽

Kezhen Fei ◽

Emily A. Hanlen-Rosado ◽

Guedy Arniella ◽

...

Keyword(s):

New York ◽

Weight Loss ◽

Low Income ◽

Diabetes Prevention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Oral Glucose ◽

East Harlem ◽

The Impact

There is a need for diabetes prevention efforts targeting vulnerable populations. Our community–academic partnership, the East Harlem Partnership for Diabetes Prevention, conducted a randomized controlled trial to study the impact of peer led diabetes prevention workshops on weight and diabetes risk among an economically and racially diverse population in East Harlem, New York. We recruited overweight/obese adults from more than 50 community sites and conducted oral glucose tolerance testing and completed other clinical assessments and a health and lifestyle survey. We randomized prediabetic participants to intervention or delayed intervention groups. Intervention participants attended eight 90-minute peer-led workshop sessions at community sites. Participants in both groups returned for follow-up assessments 6 months after randomization. The main outcomes were the proportion of participants who achieved 5% weight loss, percentage weight loss, and change in the probability of developing diabetes over the next 7.5 years according to the San Antonio Diabetes Prediction Model. We enrolled 402 participants who were mainly female (85%), Latino (73%) or Black (23%), foreign born (64%), and non-English speaking (58%). At 6 months, the intervention group lost a greater percentage of their baseline weight, had significantly lower rise in HbA1c (glycated hemoglobin), decreased risk of diabetes, larger decreases in fat and fiber intake, improved confidence in nutrition label reading, and decrease in sedentary behavior as compared with the control group. Thus, in partnership with community stakeholders, we created an effective low-resource program that was less intensive than previously studied programs by incorporating strategies to engage and affect our priority population.

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A computerised tailored intervention for increasing intakes of fruit, vegetables, brown bread and wholegrain cereals in adolescent girls

Public Health Nutrition ◽

10.1017/s1368980009992953 ◽

2010 ◽

Vol 13 (8) ◽

pp. 1271-1278 ◽

Cited By ~ 7

Author(s):

Gail Rees ◽

Savita Bakhshi ◽

Alecia Surujlal-Harry ◽

Mikis Stasinopoulos ◽

Anna Baker

Keyword(s):

Dietary Intake ◽

Adolescent Girls ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Tailored Intervention ◽

Motivation To Change ◽

Brown Bread

AbstractObjectiveTo evaluate the effectiveness of a computer-generated tailored intervention leaflet compared with a generic leaflet aimed at increasing brown bread, wholegrain cereal, fruit and vegetable intakes in adolescent girls.DesignClustered randomised controlled trial. Dietary intake was assessed via three 24 h dietary recalls.SettingEight secondary schools in areas of low income and/or high ethnic diversity, five in London and three in the West Midlands, UK.SubjectsGirls aged 12–16 years participated (n 823) and were randomised by school class to receive either the tailored intervention (n 406) or a generic leaflet (n 417).ResultsAt follow-up 637 (77 %) participants completed both baseline and follow-up dietary recalls. The tailored intervention leaflet had a statistically significant effect on brown bread intake (increasing from 0·39 to 0·51 servings/d) with a smaller but significant increase in the control group also (increasing from 0·28 to 0·35 servings/d). The intervention group achieved 0·05 more servings of brown bread daily than the control group (P < 0·05), which is equivalent to 0·35 servings/week. For the other foods there were no significant effects of the tailored intervention.ConclusionsThe intervention group consumed approximately 0·35 more servings of brown bread weekly than the control group from baseline. Although this change between groups was statistically significant the magnitude was small. Evaluation of the intervention was disappointing but the tailored leaflet was received more positively in some respects than the control leaflet. More needs to be done to increase motivation to change dietary intake in adolescent girls.

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