Randomized Community Intervention Trial Research Articles

Effectiveness of an App for tobacco cessation in pregnant smokers (TOBBGEST): study protocol

BackgroundTobacco consumption during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant smokers and their foetus. Even though pregnant smokers are conscious about the negative effects of tobacco consumption, they also had barriers for smoking cessation and most of them continue smoking, being a major public health problem. The aim of this study is to determine the effectiveness of an application (App) for mobile devices, designed with a gamification strategy, in order to help pregnant smokers to quit smoking during pregnancy and in the long term.MethodsThis study is a multicentre randomized community intervention trial. It will recruit pregnant smokers (200 participants/group), aged more than 18 years, with sporadically or daily smoking habit in the last 30 days and who follow-up their pregnancy in the Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Departments. All the participants will have the usual clinical practice intervention for smoking cessation, whereas the intervention group will also have access to the App. The outcome measure will be prolonged abstinence at 12 months after the intervention, as confirmed by expired-carbon monoxide and urinary cotinine tests. Results will be analysed based on intention to treat. Prolonged abstinence rates will be compared, and the determining factors will be evaluated using multivariate statistical analysis.DiscussionThe results of this study will offer evidence about the effectiveness of an intervention using a mobile App in smoking cessation for pregnant smokers, to decrease comorbidity associated with long-term smoking. If this technology is proven effective, it could be readily incorporated into primary care intervention for all pregnant smokers.Trial registrationClinicaltrials.gov ID NCT05222958. Trial registered 3 February 2022.

Proactive community case management decreased malaria prevalence in rural Madagascar: results from a cluster randomized trial

BackgroundMalaria remains a leading cause of morbidity and mortality worldwide, with progress in malaria control stalling in recent years. Proactive community case management (pro-CCM) has been shown to increase access to diagnosis and treatment and reduce malaria burden. However, lack of experimental evidence may hinder the wider adoption of this intervention. We conducted a cluster randomized community intervention trial to assess the efficacy of pro-CCM at decreasing malaria prevalence in rural endemic areas of Madagascar.MethodsTwenty-two fokontany (smallest administrative unit) of the Mananjary district in southeast Madagascar were selected and randomized 1:1 to pro-CCM (intervention) or conventional integrated community case management (iCCM). Residents of all ages in the intervention arm were visited by a community health worker every 2 weeks from March to October 2017 and screened for fever; those with fever were tested by a rapid diagnostic test (RDT) and treated if positive. Malaria prevalence was assessed using RDTs on all consenting study area residents prior to and following the intervention. Hemoglobin was measured among women of reproductive age. Intervention impact was assessed via difference-in-differences analyses using logistic regressions in generalized estimating equations.ResultsA total of 27,087 and 20,475 individuals participated at baseline and endline, respectively. Malaria prevalence decreased from 8.0 to 5.4% in the intervention arm for individuals of all ages and from 6.8 to 5.7% in the control arm. Pro-CCM was associated with a significant reduction in the odds of malaria positivity in children less than 15 years (OR = 0.59; 95% CI [0.38–0.91]), but not in older age groups. There was no impact on anemia among women of reproductive age.ConclusionThis trial suggests that pro-CCM approaches could help reduce malaria burden in rural endemic areas of low- and middle-income countries, but their impact may be limited to younger age groups with the highest malaria burden.Trial registrationNCT05223933. Registered on February 4, 2022

Effectiveness of micronutrient dietary intake and micronutrients fortifed milk to improve serum zinc concentrations of primary school children

Micronutrient dietary intake of primary school children was evaluated at baseline survey. Then the randomized community intervention trial with pre- and post-intervention evaluation aims to evaluate effectiveness of micronutrient dietary intake and micronutrients fortified milk to improve serum zinc concentrations of primary school children. The two common types of milk on the market are fresh milk and reconstituted milk which were used as food vehicles to fortify 21 different vitamins and minerals and given to 2 groups of school children at a dose of 2 boxes of 180 ml/day, 7 day/ week for 6 months. Each group drank one kind of milk. Control group did not drink milk during the intervention. After the end of the intervention, serum zinc concentration in the two intervention groups improved significantly compared to the baseline (p <0.01). The serum zinc concentrations were increased by 0.65±3.13 μmol/L and 0.75±3.49 μmol/L in the group of drinking micronutrient fortified fresh milk and the group of drinking micronutrients fortified reconstituted milk, respectively Zinc concentration after 6 months and difference of zinc concentration between baseline and 6 months after intervention in intervened groups were improved significantly compared to those of the control group (p<0.05).

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.

Strict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow. To evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients. Randomized community intervention trial. The control group comprised 967 patients who received standard antihypertensive drug intervention therapy from two communities, whereas the intervention group comprised 1945 patients who received antihypertensive drug and lifestyle intervention therapies from four communities in rural China. Data on lifestyle behaviors and BP measurements at baseline and 1-year follow-up were collected. A difference-in-difference logistic regression model was used to assess the effect of the intervention. BP control after the 1-year intervention was better than that at baseline in both groups. The within-group change in BP control of 59.3% in the intervention group was much higher than the 25.2% change in the control group (P < 0.001). Along with the duration of the follow-up period, systolic and diastolic BP decreased rapidly in the early stages and then gradually after 6months in the intervention group (P < 0.001). In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1month to 87.6% at 1year) (P < 0.001), more in women (45.6%) than in men (31.2%; P < 0.001). The net effect of the lifestyle intervention improved the rate of BP control by 56.1% (70.8% for men and 44.7% for women). For all physiological and biochemical factors, such as body mass index, waist circumference, lipid metabolism, and glucose control, improvements were more significant in the behavioral intervention group than those in the control group (all P < 0.001). The addition of lifestyle intervention by physicians or nurses helps control BP effectively and lowers BP better than usual care with antihypertensive drug therapy alone.

173: EFFECTIVENESS OF COMMUNITY AND SCHOOL- BASED INTERVENTIONS ON CONTROL AND PREVENTION OF TOBACCO USE IN ADOLESCENTS: A RANDOMIZED COMMUNITY INTERVENTION TRIAL

Background and aims:Most consumers of tobacco begin to consume it before age 18. The aim of this study was to determine the effect of community and school-based interventions to reduce...

Effectiveness of insecticide spraying and culling of dogs on the incidence of Leishmania infantum infection in humans: a cluster randomized trial in Teresina, Brazil.

BackgroundTo evaluate the effect of insecticide spraying for vector control and elimination of infected dogs on the incidence of human infection with L. infantum, a randomized community intervention trial was carried out in the city of Teresina, Brazil.Methods/Principal FindingsWithin each of ten localities in the city, four blocks were selected and randomized to 4 interventions: 1) spraying houses and animal pens with insecticide; 2) eliminating infected dogs; 3) combination of spraying and eliminating dogs, and 4) nothing. The main outcome is the incidence of infection assessed by the conversion of the Montenegro skin test (MST) after 18 months of follow-up in residents aged ≥1 year with no previous history of visceral leishmaniasis (VL). Reactions were measured at 48–72 h, induration of ≥5 mm considered positive. Interventions were executed after the baseline interview and repeated 6 and 12 months later. The effects of each type of intervention scheme on the incidence of infection were assessed by calculating relative risks and 95% confidence intervals using Poisson population-averaged regression models with robust variance. Among the 1105 participants, 408 (37%) were MST positive at baseline. Of the 697 negatives, only 423 (61%) were reexamined at the end of the follow-up; 151 (36%) of them converted to a positive MST. Only dog culling had some statistically significant effect on reducing the incidence of infection, with estimates of effectiveness varying between 27% and 52%, depending on the type of analysis performed.Conclusions/SignificanceIn light of the continuous spread of VL in Brazil despite the large scale deployment of insecticide spraying and dog culling, the relatively low to moderate effectiveness of dog culling and the non-significant effect of insecticide spraying on the incidence of human infection, we conclude that there is an urgent need for revision of the Brazilian VL control program.

Greater length-for-age increases the odds of attaining motor milestones in Vietnamese children aged 5-18 months.

Early childhood malnutrition has been associated with delayed development. Limited data exist however about the timing of developmental delay early in life. We assessed motor milestone (MM) achievement using the World Health Organization's windows of achievement for gross motor milestones. We performed secondary analysis of baseline data of 158 Vietnamese children aged 5-18 months from a randomized community intervention trial. Median age of motor milestone achievement was compared to WHO reported medians. Multivariate logistic regression was used to identify socioeconomic, anthropometric and dietary factors associated with motor milestone achievement during the windows of achievement. Thirty four per cent of the children were stunted. Median age of MM achievement of Vietnamese children lagged by 2.4-3.7 months, compared to the WHO median for all MMs. Greater length-for-age increased the odds for walking with assistance, standing alone and walking alone by more than 3 times. Greater weight-for-age increased the odds by 3.6 for hand-and-knees crawling. Likewise, frequency of daily complementary feeding raised the odds by 3.6 for standing with assistance. In this first application of WHO windows of achievement in Viet Nam, pre-schoolers achieved motor milestones later than WHO reported median age. High prevalence of stunting and association of length-for-age with motor milestone achievement underscore the importance of addressing chronic malnutrition to optimize children's growth and development.

‘Decision support system (DSS) for prevention of cardiovascular disease (CVD) among hypertensive (HTN) patients in Andhra Pradesh, India’ – a cluster randomised community intervention trial

BackgroundVery few studies having decision support systems as an intervention report on patient outcomes for cardiovascular disease in the Western world. The potential role of decision support system for the management of blood pressure among Indian hypertensives remains unclear. We propose a cluster randomised trial that aims to test the effectiveness and cost effectiveness of DSS among Indian hypertensive patients.MethodsThe trial design is a cluster randomised community intervention trial, in which the participants would be adult male and female hypertensive patients, in the age group of 35 to 64 years, reporting to the Primary Health Care centres of Mahabubnagar district, Andhra Pradesh, India. The objective of the study is to test the effectiveness and compare the cost effectiveness and cost utility among hypertensive subjects randomized to receive either decision support system or a chart based algorithmic support system in urban and rural areas of a district in the state of Andhra Pradesh, India (baseline versus 12 months follow up). The primary outcome would be a comparison of the systolic blood pressure at 0 and 12 months among hypertensive patients randomized to receive the decision support system or the chart based algorithmic support system. Computer generated randomisation and an investigator and analyser blinded method would be followed. 1600 participants; 800 to each arm; each arm having eight clusters of hundred participants each have been recruited between 01 August 2011 - 01 March 2012. A twelve month follow up will be completed by March 2013 and results are expected by April 2013.DiscussionThis cluster randomized community intervention trial on DSS will enable policy makers to find out the effectiveness, cost effectiveness and cost utility of decision support system for management of blood pressure among hypertensive patients in India. Most of the previous studies on decision support system have focused on physician performance, adherence and on preventive care reminders. The uniqueness of the proposed study lies in finding out the effectiveness of a decision support system on patient related outcomes.Trial registrationCTRI/2012/03/002476, Clinical Trial Registry - India.

Abstract B4: Health-related and sociocultural correlates of physical activity among an African American cohort

Abstract Background: Participation in physical activity has been shown to have many health benefits including contributions to the reduction in rates of all-cause morbidity/mortality and helps in the prevention of many chronic diseases, including cancer. Despite these known health benefits, national data indicates that adherence to recommendations are low, with the rates being the lowest among African Americans. Socio-demographic characteristics, having a history of co-morbid conditions, and physician recommendation to exercise have all been shown to influence participation. However, few studies have measured the impact of socio-cultural factors. This presentation identifies demographic, health influenced, and socio-cultural factors that have been found to play a role in physical activity participation in a cohort of African Americans. Method: African American men and women (ages 45–75), residing in a Midwest metropolitan area, participated in a two-armed randomized community intervention trial (N = 661). Each participant completed a baseline survey that contained questions regarding physical activity participation, demographic, and health related characteristics. The survey also included questions about socio-cultural (SC) factors found to be relevant in previous research with this population. Baseline data were analyzed to determine the rate of participation in physical activity as well as the rate of adherence to guidelines (i.e., 30+ minutes of moderate physical activity five or more days per week, or vigorous physical activity for 20+ minutes three or more days per week). Additional analyses examined demographic, health-related (personal history of chronic diseases and physician recommendation), and SC characteristics (mistrust, collectivism, humanism, social desirability, and nationalism) to determine their relative influence on physical activity participation and adherence to guidelines. Results: The rates of physical activity participation (83.6%) and adherence (52%) were slightly higher for this cohort than previously reported. Bivariate analyses indicated that being married, having more than a high school education, having an income of more than $40,000, being employed, receiving a physician recommendation to exercise, and having chronic disease were significantly associated with physical activity participation and adherence (p&amp;lt;0.05). Additionally, being mistrustful of the medical establishment and identifying with a collectivist viewpoint were also important. Logistic regression analyses indicated that receiving a physician recommendation to exercise, having high mistrust of the medical establishment and identifying with a collectivist viewpoint significantly influenced physical activity participation and adherence after adjustment (p&amp;lt;0.05). These findings may provide new strategies for increasing physical activity among African Americans, which can ultimately result in improvements in cancer prevention and control for this population. Citation Information: Cancer Prev Res 2010;3(1 Suppl):B4.

Family History of Diabetes, Parental Body Mass Index Predict Obesity in Latino Children

The purpose of this study is to examine the association between family history of diabetes (FHD), body mass index (BMI), and acculturation with children's BMI status. Baseline data from a randomized community intervention trial promoting healthy eating and physical activity were collected in children living in San Diego, California. A self-administered survey was completed by primary caregivers at each school assessing maternal diabetes, BMI, acculturation, and socioeconomic status (SES). Anthropometric data (height, weight, and BMI) from mothers and children were also collected. A total of 812 caregivers completed the baseline survey. Adjusting for maternal age, marital status, and socioeconomic level, women who had been diagnosed with diabetes or gestational diabetes or who received diabetes treatment were significantly more likely to have overweight children. Maternal BMI was also associated with children's weight. Maternal acculturation level was marginally associated with children's BMI. FHD, gestational diabetes, and BMI were associated with children's overweight status. More comprehensive interventions are needed to prevent obesity in Latino children and adults.

Poster 47: Enhancing Wheelchair Accessibility: Consumer Involvement and Restaurants’ Willingness to Change

Objectives: To improve restaurant accessibility and to test impact of the person providing feedback to restaurant managers. Design: Randomized community intervention trial. Setting: Community. Participants: 30 restaurants selected by people with spinal cord injury (SCI). Interventions: 3 members of Northern New Jersey Spinal Cord Injury System (NNJSCIS) research staff were randomized to visit the 30 restaurants and provide feedback: (1) the nondisabled NNJSCIS director (n=10 restaurants), (2) a wheelchair user with SCI (n=10), and (3) a nondisabled research assistant (n=10).

Controle da leishmaniose visceral em meio urbano: estudo de intervenção randomizado fatorial

The objective of this study was to evaluate the effect of vector control and elimination of infected dogs on the incidence of infection with Leishmania chagasi. A randomized community intervention trial was carried out in Teresina between 1995 and 1996. The area was divided in 34 blocks randomically allocated to 4 types of intervention: 1) spraying houses and animal pens with insecticide; 2) spraying houses and eliminating infected dogs; 3) combination of spraying houses and animal pens, and eliminating infected dogs, and 4) only spraying houses. In comparison to blocks receiving only household spraying, culling dogs decreased in 80% the incidence of infection. Spraying animal pens, associated or not with culling dogs, showed no significant effect. The protection offered by culling dogs suggests that this strategy might reduce the source of infection for the vector.

Evaluation of a drama-in-education programme to increase AIDS awareness in South African high schools: a randomized community intervention trial

Evaluation of a drama-in-education programme to increase AIDS awareness in South African high schools: a randomized community intervention trial

Evaluation of a Drama-in-Education Programme to Increase AIDS Awareness in South African High Schools: A Randomized Community Intervention Trial

A community intervention trial was undertaken in KwaZulu Natal, South Africa to evaluate the effectiveness of a high school drama-in-education programme. Seven pairs of secondary schools were randomized to receive either written information about HIV/AIDS or the drama programme. Questionnaire surveys of knowledge, attitude and behaviour were compared before and 6 months after the interventions. One thousand and eighty students participated in the first survey and 699 in the second. Improvements in knowledge (P=0.0002) and attitudes (P < 0.00001) about HIV/AIDS were demonstrated in pupils at schools receiving the drama programme when compared to pupils receiving written information alone. These changes were independent of age, gender, school or previous sexual experience. In schools receiving the drama programme, sexually active pupils reported an increase in condom use (P < 0.01). It is important to provide resources to sustain such programmes and to obtain stronger evidence of effect on behaviour by measuring changes in HIV incidence.

A randomized community intervention trial to increase awareness and knowledge of the role of periconceptional folate in women of child-bearing age.

OBJECTIVES: To determine the effect of a consumer-directed information campaign to increase knowledge of folate for the prevention of neural tube defects among women of child-bearing age, and to measure women's recall of sources of information and knowledge about folate. DESIGN: A community randomized trial. SETTING: Three matched pairs of geographically distinct Local Government Areas in the state of Victoria, Australia. INTERVENTION: Printed information recommending folate intake to decrease the risk of neural tube defects was disseminated to women of child-bearing age in three of the Local Government Areas selected randomly. MAIN OUTCOME MEASURE: The proportion of women aware of the association between folate and spina bifida. RESULTS: Of 1197 women interviewed prior to the intervention, 12.4% (adjusted for the cluster and population sampling unit) were aware of folate and neural tube defects. After the intervention, there was not only a significant background increase of 3.4% (P=0.02) in folate awareness since the pre-intervention survey (n=603), but also a significant additional increase of 4.0% (P=0.04) owing to the intervention itself (n=603). Only 70% of women who were aware of folate knew the correct timing. CONCLUSIONS: The provision of printed educational material can increase folate awareness among women of child-bearing age. A comprehensive, long-term and ongoing health promotion campaign including such material, together with initiatives by relevant health service providers and the food industry, could best address the current low levels of folate awareness among women of child-bearing age.

Workplace compliance with a no-smoking law: a randomized community intervention trial.

Compliance with state and local laws restricting smoking in public places and workplaces has not been systematically evaluated. We assessed workplace compliance with a comprehensive no-smoking law adopted in Brookline, Mass, and tested whether mailing information to businesses increased awareness of and compliance with the law. We conducted a random sample telephone survey of 299 businesses (87% response rate). Self-reported compliance was validated by direct observations. One year after its adoption, the law was popular with businesses. The prevalence of smoking restrictions, smoking policies, and no-smoking signs was 80%, 59%, and 40%, respectively. One third of businesses banned smoking. Full compliance with the law was low, however, because few businesses posted a copy of their smoking policy as required. The mailing increased employers' awareness of the law. Employers sent the mailing also reported better compliance, but this was not confirmed by direct observations. The law was popular and contributed to a high prevalence of workplace smoking restrictions. Different interpretations of the law by policymakers and businesses seemed to explain why formal compliance was low. The mailing increased awareness of, but not compliance with, the law.

The impact of vitamin A supplementation on morbidity: a randomized community intervention trial.

A randomized community trial investigated the impact of vitamin A supplementation on symptoms of respiratory and enteric infections among Indonesian children aged 1 to 5 years. A sample of 450 villages had been randomized into 229 villages that received vitamin A distribution and 221 that were observed as controls. The prevalence rates of cough, fever, and diarrhea were reduced in the treatment villages compared with the control villages by 8%, 5%, and 11%, respectively, but the reduction was not statistically significant. These results indicate that vitamin A supplements did not produce a substantial reduction in these symptoms, in spite of a reported reduction in all-cause mortality.