A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial

Background Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. Objective The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. Methods Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. Results Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86). Conclusions The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. Trial Registration Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927 International Registered Report Identifier (IRRID) RR2-10.1186/s12884-017-1228-5

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A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial (Preprint)

10.2196/preprints.15773 ◽

2019 ◽

Author(s):

Matthijs R van Dijk ◽

Maria P H Koster ◽

Elsje C Oostingh ◽

Sten P Willemsen ◽

Eric A P Steegers ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Lifestyle Intervention ◽

Early Pregnancy ◽

Vegetable Intake ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Noncommunicable Diseases ◽

Control Group ◽

Randomized Controlled

BACKGROUND Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. OBJECTIVE The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. METHODS Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. RESULTS Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86). CONCLUSIONS The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. CLINICALTRIAL Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12884-017-1228-5

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Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial (Preprint)

10.2196/preprints.14802 ◽

2019 ◽

Author(s):

Su Lin Lim ◽

Jolyn Johal ◽

Kai Wen Ong ◽

Chad Yixian Han ◽

Yiong Huak Chan ◽

...

Keyword(s):

Blood Pressure ◽

Weight Loss ◽

Fatty Liver ◽

Lifestyle Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Control Group ◽

Nonalcoholic Fatty Liver ◽

Randomized Controlled

BACKGROUND The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. CONCLUSIONS Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp

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Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial (Preprint)

10.2196/preprints.15057 ◽

2019 ◽

Author(s):

Young Ho Yun ◽

EunKyo Kang ◽

Young Min Cho ◽

Sang Min Park ◽

Yong-Jin Kim ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Disease Control ◽

Behavior Management ◽

Management Strategy ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Control Group ◽

Cardiovascular Risks ◽

Randomized Controlled

BACKGROUND In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. OBJECTIVE This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health–based electronic program (Smart Healthing). METHODS A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA1c) <7.0%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL. RESULTS The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (<italic>P</italic><.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; <italic>P</italic><.05). There was a significant reduction in HbA1c in the intervention group compared with the control group (difference=0.54%; <italic>P</italic>≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA1c (vs 0% among controls; <italic>P</italic>≤.05). CONCLUSIONS A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. CLINICALTRIAL ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044

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Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/14802 ◽

2020 ◽

Vol 8 (4) ◽

pp. e14802

Author(s):

Su Lin Lim ◽

Jolyn Johal ◽

Kai Wen Ong ◽

Chad Yixian Han ◽

Yiong Huak Chan ◽

...

Keyword(s):

Blood Pressure ◽

Weight Loss ◽

Fatty Liver ◽

Lifestyle Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Control Group ◽

Nonalcoholic Fatty Liver ◽

Randomized Controlled

Background The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. Objective We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. Methods This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. Results The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. Conclusions Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp

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Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15057 ◽

2020 ◽

Vol 22 (1) ◽

pp. e15057

Author(s):

Young Ho Yun ◽

EunKyo Kang ◽

Young Min Cho ◽

Sang Min Park ◽

Yong-Jin Kim ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Disease Control ◽

Behavior Management ◽

Management Strategy ◽

Controlled Trial ◽

Intervention Group ◽

Mobile App ◽

Control Group ◽

Cardiovascular Risks ◽

Randomized Controlled

Background In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. Objective This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health–based electronic program (Smart Healthing). Methods A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA1c) <7.0%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL. Results The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; P<.05). There was a significant reduction in HbA1c in the intervention group compared with the control group (difference=0.54%; P≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA1c (vs 0% among controls; P≤.05). Conclusions A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. Trial Registration ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044

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Randomized controlled trial of educational intervention to increase consumption of vegetables by Japanese university students

Health Education ◽

10.1108/he-12-2017-0070 ◽

2018 ◽

Vol 118 (4) ◽

pp. 290-303 ◽

Cited By ~ 2

Author(s):

Makoto Ohtsuki ◽

Katsumi Shibata ◽

Tutomu Fukuwatari ◽

Yuko Sasaki ◽

Kunihiko Nakai

Keyword(s):

Randomized Controlled Trial ◽

University Students ◽

Intervention Studies ◽

Vegetable Intake ◽

Vegetable Consumption ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Content Type ◽

Randomized Controlled

Purpose The purpose of this paper is to evaluate the effect of an educational intervention to increase vegetable consumption by university students. Design/methodology/approach This study is an open, parallel randomized controlled trial for 25 weeks. University students aged 18-24 years were divided into an intervention group (n=52) and a control group (n=52). Vegetable intake was assessed using a questionnaire. Findings On investigation, the results indicated that the vegetable intake of the intervention group was well maintained at the end of the study, whereas that of the control group was significantly decreased by the seasonal change. This research showed that using three educational projects could significantly improve the vegetable consumption of university students. Research limitations/implications These results suggest that the educational approach is a promising method to improve the vegetable consumption status, particularly the consumption of green and yellow vegetables, by university students. Originality/value This parallel randomized controlled study investigated intervention via educational approaches, including a lecture on the nutritional significance of vegetable intake, a tour of an agricultural farm, and learning of cooking skills, focusing on increasing the consumption of vegetables by university students. Although there have been many intervention studies aimed at improving intake of vegetables in the world, there have been no intervention studies on the vegetable intake of young adults in Japan.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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