Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Abstract Background There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aim of this study is to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy (PT) and describe the patient-, study protocol- and setting-related factors related to women’s ineligibility and refusal to participate in the study Methods Qualitative and quantitative data on recruitment to a 2x2 factorial feasibility clinical trial were used. 18 women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focal group discussions and data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. Results Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (>20 weeks) at first prenatal appointment. The study recruited 70 women in 56 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. Non-participation of those eligible after periodontal examination was approximately 24% (22 out 92) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, unresponsive to phone calls, and disconnected telephones). The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthy and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation cost) could hinder participation in the study. Conclusion Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related socio-demographic barriers and setting-related factors. Our data illustrates the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings.

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Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

10.21203/rs.2.10813/v2 ◽

2020 ◽

Author(s):

Amanda Rodrigues Amorim Adegboye ◽

Paula G Cocate ◽

Camila Benaim ◽

Maria Claudia da Veiga Carvalho ◽

Michael M Schlüssel ◽

...

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Low Income ◽

Quantitative Data ◽

Health Centre ◽

Feasibility Trial ◽

Random Allocation ◽

Eligibility Criteria ◽

Related Factors ◽

Phone Calls

Abstract Background: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aim of this study is to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy (PT) and describe the patient-, study protocol- and setting-related factors related to women’s ineligibility and refusal to participate in the study. Methods: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2x2 factorial feasibility clinical trial were used. 18 women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions and data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. Results: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (>20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, unresponsive to phone calls, and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthy and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation cost) could hinder participation in the study. Conclusion: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related socio-demographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings.

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Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17218023 ◽

2020 ◽

Vol 17 (21) ◽

pp. 8023

Author(s):

Amanda Rodrigues Amorim Adegboye ◽

Danilo Dias Santana ◽

Paula Guedes Cocate ◽

Camila Benaim ◽

Pedro Paulo Teixeira dos Santos ◽

...

Keyword(s):

Vitamin D ◽

Pregnant Women ◽

Low Income ◽

Retention Rate ◽

Recruitment Rate ◽

Feasibility Trial ◽

Random Allocation ◽

Treatment Groups ◽

Late Treatment ◽

Participant Flow

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca + VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.

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Acceptability, Adherence and Retention of a Feasibility Randomised Trial on Periodontal Treatment and Vitamin D/ Calcium Milk Fortification among Pregnant Women: A Mixed-Methods Evaluation

10.20944/preprints202009.0220.v1 ◽

2020 ◽

Author(s):

Amanda Rodrigues Amorim Adegboye ◽

Danilo Dias Santana ◽

Paula Guedes Cocate ◽

Camila Benaim ◽

Pedro Paulo Teixeira dos Santos ◽

...

Keyword(s):

Vitamin D ◽

Mixed Methods ◽

Pregnant Women ◽

Low Income ◽

Retention Rate ◽

Randomised Trial ◽

Feasibility Trial ◽

Random Allocation ◽

Treatment Groups ◽

Mixed Methods Evaluation

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca+VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2x2 factorial feasibility trial used a mixed-methods evaluation. 69 pregnant women were randomly allocated to four groups: 1.fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2.placebo and milk plus early PT; 3.fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4.placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.

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Animal-Assisted Activity in Critically Ill Older Adults: A Randomized Pilot and Feasibility Trial

Biological Research For Nursing ◽

10.1177/1099800420920719 ◽

2020 ◽

Vol 22 (3) ◽

pp. 412-417

Author(s):

Sandy Branson ◽

Lisa Boss ◽

Shannan Hamlin ◽

Nikhil S. Padhye

Keyword(s):

Stress Responses ◽

Feasibility Trial ◽

Eligibility Criteria ◽

Hospital Policy ◽

Related Factors ◽

Icu Patients ◽

Indwelling Catheters ◽

Control Intervention ◽

Number Of Patients ◽

Before And After

Background: Limited evidence suggests the efficacy of animal-assisted activities (AAA) in improving biobehavioral stress responses in older patients in intensive care units (ICUs). Objectives: To assess the feasibility of an AAA (dog) intervention for improving biobehavioral stress response, measured by self-reported stress and anxiety and salivary cortisol, C-reactive protein, and interleukin-1β in older ICU patients, we examined enrollment, attrition, completion, data collection, and biobehavioral stress responses. Methods: ICU patients ≥60 years old were randomly assigned to a 10-min AAA intervention or control/usual ICU care. Attitudes toward pets were assessed before the intervention. Self-reported stress and anxiety and salivary stress biomarkers were collected before and after the intervention and the usual care condition. Results: The majority of patients were ineligible due to lack of decisional capacity, younger age, inability to provide saliva specimens, or critical illness. Though 15 participants were randomly allocated (AAA = 9; control = 6), only 10 completed the study. All participants completed the questionnaires; however, saliva specimens were significantly limited by volume. AAA was associated with decreases in stress and anxiety. Biomarker results were variable and revealed no specific trends associated with stress responses. Conclusions: Barriers to recruitment included an insufficient number of patients eligible for AAA based on hospital policy, difficulty finding patients who met study eligibility criteria, and illness-related factors. Recommendations for future studies include larger samples, a stronger control intervention such as a visitor without a dog, greater control over the AAA intervention, and use of blood from indwelling catheters for biomarkers.

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1527Effect of a text-messaging intervention on oral self-care practices in antenatal women in Delhi, India

International Journal of Epidemiology ◽

10.1093/ije/dyab168.064 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

Author(s):

Saurav Basu ◽

Anjali Rajeev ◽

Suneela Garg ◽

Mongjam Singh

Keyword(s):

Health Promotion ◽

Oral Health ◽

Pregnant Women ◽

Low Income ◽

Dental Health ◽

Health Centre ◽

Text Message ◽

Text Messages ◽

Oral Health Promotion ◽

Text Message Intervention

Abstract Objective to determine the effect of a mHealth (text-message) intervention compared with a structured health educational session on the oral care and hygiene practices of pregnant women. Methods We conducted a pilot Randomized Control Trial parallel design superiority trial with a 1:1 allocation ratio. A total of 76 pregnant women up-to 20 weeks of gestational age and capable of reading mobile phone text-messages were recruited during August-October’ 2020 from the antenatal clinic of a primary health centre in a low-income urban agglomeration in Delhi, India. The mHealth intervention arm participants were sent a daily text-message for 30 days while all participants were provided a face-face, brief didactic structured educational sessions towards oral health promotion. Results The baseline characteristics of both groups were comparable in terms of age-structure, education, parity, and oral hygiene but differed in terms of oral health problems. Post-intervention, although, the twice-brushing frequency increased in both arms, only the mHealth arm revealed a statistically significant reduction in the incidence of missed twice daily brushing episodes (p = 0.016). The absolute effect size for the primary outcome signifying the difference in the proportion of participants reporting twice daily brushing frequency habit between the mHealth and comparison arms’ was 0.090, the Cohen’s H was 0.182, and the odds of twice brushing habit in the mHealth arm was 1.44 times higher than in the comparison arm. Conclusions a mHealth based daily text-message intervention for one month was not superior to a one-time brief didactic structured educational intervention for oral health promotion in antenatal women. Keywords mHealth; Dental health promotion; Dental health education; Antenatal care

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Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Trials ◽

10.1186/s13063-020-4142-5 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 2

Author(s):

Amanda Rodrigues Amorim Adegboye ◽

Paula G. Cocate ◽

Camila Benaim ◽

Maria Claudia da Veiga Soares Carvalho ◽

Michael M. Schlüssel ◽

...

Keyword(s):

Pregnant Women ◽

Low Income ◽

Dental Care ◽

Feasibility Trial ◽

Care Intervention

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Exploratory Efficacy of Calcium-Vitamin D Milk Fortification and Periodontal Therapy on Maternal Oral Health and Metabolic and Inflammatory Profile

Nutrients ◽

10.3390/nu13030783 ◽

2021 ◽

Vol 13 (3) ◽

pp. 783

Author(s):

Amanda Rodrigues Amorim Adegboye ◽

Danilo Dias Santana ◽

Pedro Paulo Teixeira dos Santos ◽

Paula Guedes Cocate ◽

Camila Benaim ◽

...

Keyword(s):

Vitamin D ◽

Pregnant Women ◽

Large Scale ◽

Health Centre ◽

Randomised Trial ◽

Periodontal Therapy ◽

Feasibility Trial ◽

Periodontal Health ◽

Powdered Milk ◽

Public Health Centre

In this 2 × 2 factorial, outcome-assessor blinded, feasibility randomised trial we explored the effect of a non-pharmaceutical multi-component intervention on periodontal health and metabolic and inflammatory profiles among pregnant women with periodontitis receiving prenatal care in a Brazilian public health centre. 69 pregnant women (gestational age ≤20 weeks, T0) were randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus periodontal therapy during pregnancy (early PT) (n = 17); (2) placebo sachet and powdered milk plus early PT (n = 15); (3) fortified sachet and powdered milk plus late PT (after delivery) (n = 19); (4) placebo sachet and powdered milk plus late PT (n = 18). Third trimester (T1) and 6–8 weeks postpartum (T2) exploratory outcomes included periodontal health (% sites with bleeding on probing (BOP)), glucose, insulin, C-Reactive Protein, serum calcium and vitamin D. The mean BOP was significantly reduced in the early PT groups, while BOP worsened in the late PT groups. No significant effect of fortification on BOP was observed. Changes in glucose levels and variation on birthweight did not differ among groups This feasibility trial provides preliminary evidence for estimating the minimum clinically important differences for selected maternal outcomes. A large-scale trial to evaluate the interventions’ clinical benefits and cost-effectiveness is warranted.

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A prospective clinical trial to evaluate the prevalence of thyroid disorder among pregnant women and obstetrical and fetal outcome in a tertiary health centre located in central India

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20203329 ◽

2020 ◽

Vol 9 (8) ◽

pp. 3393

Author(s):

Manjari G. Jain ◽

Neeraj K. Jain ◽

Mita Mazumdar

Keyword(s):

Clinical Trial ◽

Pregnant Women ◽

Health Centre ◽

First Trimester ◽

Fetal Outcome ◽

Prospective Clinical Trial ◽

Research Centre ◽

Overt Hypothyroidism ◽

Thyroid Disorder ◽

Medical College

Background: A prospective clinical trial to evaluate the prevalence of thyroid disorder among pregnant women and obstetrical and fetal outcome was done in a tertiary health centre (RKDF Medical College and Research Centre, Bhopal) located in central India.Methods: This prospective study was carried out in antenatal women in their first trimester attending antenatal OPD in RKDF Medical College and Research Centre, Bhopal, Madhya Pradesh to know the prevalence of thyroid disorder and its association with pregnancy outcome.Results: In this study prevalence of thyroid disorder was 12.4%, subclinical hypothyroidism 7.2%, overt hypothyroidism 3.4%, subclinical hyperthyroidism 1.4%, overt hyperthyroidism 0.4%. Thyroid disorder is responsible for several obstetrical and fetal complication like pre-eclampsia, preterm delivery, abortion, IUGR and low birth weight.Conclusions: Thyroid disorder associated with poor obstetrical outcome and fetal complication. so timely diagnosis and treatment is required. Universal screening should be preferred over high-risk screening because of high prevalence of the disease in India.

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Birth preparedness and complication readiness for a safe motherhood among antenatal women attending an urban health centre, Pudupet

International Journal of Community Medicine and Public Health ◽

10.18203/2394-6040.ijcmph20204728 ◽

2020 ◽

Vol 7 (11) ◽

pp. 4345

Author(s):

M. D. Vidhyashree ◽

Janani S. ◽

Kavipriya P. ◽

Lakshmi V. ◽

Sindhukavi S. ◽

...

Keyword(s):

Pregnant Women ◽

Urban Health ◽

Health Centre ◽

Control Measures ◽

Safe Motherhood ◽

Birth Preparedness ◽

Related Factors ◽

Cross Sectional ◽

Complication Readiness ◽

Training Centre

Background: Maternal and neonatal mortality is a significant medical issue in creating nations. Birth preparedness and complication readiness (BPCR) is a technique to urge pregnant ladies to settle on brief choices to look for care from talented birth orderlies. Most investigations of BPCR have been led in creating nations, BPCR status and related factors in Pudupet are at present obscure. Objectives were to evaluate BPCR for a sheltered parenthood among antenatal (AN) moms going to an urban health center, Pudupet and to recognize the factors affecting BPCR.Methods: The examination was directed among 104 pregnant women in a community based cross sectional study conducted in urban health training centre (UHTC) was conducted among 104 pregnant women as per inclusion criteria by simple random sampling. A predesigned semi structured questionnaire by interview method after taking informed consent was used to calculate socio demographic details and antenatal care. Data were entered and analysed in Epi-info software.Results: Overall BPCR score was 96.15% of women scored 3 and above. But awareness about blood donor (13.5%) was less among antenatal mothers. Money savings either cash or insurance was kept ready by 49 (47.1%). Articles kept ready by 42 (40.4%) AN mothers. Among 104, 71(68.3%) had awareness over birth control measures. Significance seen under statistical analysis among sociodemographic factors like age, education, socioeconomic status, husband’s education and type of family had statistically significant associations with BPCR components.Conclusions: Birth preparedness and difficulty status is fundamental and viable methodology that supports mother, family and network to design a protected conveyance.

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