An Intervention to Promote Healthy Behaviors and service utilisation for Hypertension and Diabetes Management in Rural Bangladesh: a pilot randomised controlled trial

INTERVENTION: Intervention overview and components: The intervention was a structured, 12‐week community–facility programme for adults living with coexisting hypertension and diabetes in Chirirbandar Upazila, Dinajpur District, rural Bangladesh. The intervention comprised four integrated components, including individualised home‐based counselling, an interactive group workshop, guided visits to government healthcare facilities, and educational and self‐monitoring materials. Individualised counselling addressed knowledge of hypertension and diabetes and their risk factors; healthy diet, including increased fruit and vegetable intake and reduced salt intake; physical activity; smoking cessation and reduced alcohol consumption where applicable; reduction of exposure to household or indoor air pollution; medication adherence; stress and other barriers to self‐care; blood pressure and blood glucose monitoring; recognition of complications and warning signs; individual health‐goal setting; regular check‐ups and follow‐up; and appropriate use of qualified healthcare providers. Counselling was tailored to each participant’s baseline circumstances, existing health behaviours, medication use, healthcare‐utilisation practices, personal goals, and reported barriers. The interactive workshop reinforced knowledge of hypertension and diabetes, healthy behaviours, medication and treatment adherence, self‐care, prevention of complications, and disease‐monitoring skills. It included practical demonstrations of blood pressure and blood glucose monitoring and enabled direct communication between participants, government healthcare providers, local administrators, elected local representatives, and community leaders. Participants could ask questions about available services, service costs, CONDITION: Cardiovascular ‐ Hypertension Diabetes;Hypertension; ; Diabetes ; Hypertension Metabolic and Endocrine ‐ Diabetes PRIMARY OUTCOME: Feasibility: Intervention adherence[Assessed as a composite outcome from attendance at the 12 weekly counselling sessions, interactive workshops, and guided healthcare‐facility visits using intervention attendance and delivery logs. At 12 weeks after intervention commencement.] Feasibility: Recruitment rate[Calculated as the percentage of eligible individuals who enrolled using screening, recruitment and enrolment records. During the recruitment period] Feasibility: Retention rate[Calculated as the percentage of randomised participants who completed the study using follow‐up and endline records. Throughout the 12‐week intervention period] SECONDARY OUTCOME: Feasibility: Acceptability—this is a primary outcome[Assessed through participant satisfaction and perceived helpfulness using a study‐specific structured questionnaire with Likert‐scale responses. At 12 weeks after intervention commencement.] Healthy Behavior: Diabetic plate practice[Assessed as the self‐reported frequency of following the recommended diabetic plate practice, measured in servings per week using the study questionnaire. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behavior: Food pyramid use[Assessed as the self‐reported number of days per week on which participants followed the recommended food pyramid, measured using the study questionnaire. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy behavior: Frequency of smoked or smokeless tobacco use ‐ this will be assessed as a composite outcome[Assessed using a self‐report questionnaire and measured as the number of times tobacco was used per week. ; These items were adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy behavior: Indoor air pollution[Assessed using selected items adapted from the WHO STEPS Household Energy Use module and reported as the percentage of participants exposed to indoor air pollution. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behavior: Salt Intake[Assessed independently as the estimated self‐reported amount of salt consumed per person per day, measured in grams per day per person using the study questionnaire. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behavior: Sugar Intake[Assessed as the self‐reported number of servings of sugar‐containing foods or added sugar consumed per week, measured using the study questionnaire. ; The items were adapted from the WHO STEPS dietary assessment format and modified for this study to assess sugary food consumption Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behaviour: Alcohol Consumption[Assessed using a self‐report questionnaire and reported as the percentage of participants who consumed alcohol during the previous 30 days. ; The alcohol‐use items were adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behaviour: Fruit and vegetable intake[Assessed as a composite secondary outcome based on self‐reported weekly fruit intake and weekly vegetable intake measured using the study questionnaire. ; The dietary intake items were adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behaviour: Medication Adherence[Consistency in taking prescribed medications using self reported questionnaire adjusted from Morisky scale of medication adherence Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behaviour: Physical Activity[Assessed as a composite secondary outcome based on the self‐reported frequency, duration and intensity of physical activity undertaken during a usual week, measured using the study questionnaire. ; The physical activity items were adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Healthy Behaviour: Smoked or smokeless tobacco use ‐ this will be assessed as a composite outcome[Assessed as a composite secondary outcome based on self‐reported use of smoked and/or smokeless tobacco, measured using the study questionnaire. ; The tobacco‐use items were adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Physical measurements & disease control: Blood glucose[Point‐of‐care testing using a finger‐prick glucometer Baseline before randomisation and 12 weeks after intervention commencement.] Physical measurements & disease control: Blood pressure[Using calibrated BP machine Baseline before randomisation and 12 weeks after intervention commencement.] Physical measurements & disease control: BMI[Height & weight using scale Baseline before randomisation and 12 weeks after intervention commencement.] Process evaluation: Adoption[Assessed as a composite secondary process‐evaluation outcome covering stakeholder motivation to support the intervention, delivery challenges, adaptations, perceived effectiveness and sustainability factors. Data were collected from healthcare providers, community leaders and implementers through semi‐structured, one‐to‐one, face‐to‐face interviews with a research team member, lasting approximately 5–7 minutes. Component indicators were analysed descriptively and were not combined into a numerical score. At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.] Process evaluation: Effectiveness[Assessed as a composite secondary process‐evaluation outcome covering perceived changes in health behaviours, perceived health improvements and useful intervention components. Data were collected through a semi‐structured, one‐to‐one, face‐to‐face interview with a research team member, lasting approximately 5–7 minutes. Component indicators were analysed descriptively and were not combined into a numerical score. At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.] Process evaluation: Implementation[Assessed as a composite secondary process‐evaluation outcome covering intervention‐delivery fidelity, implementation challenges, adaptations and additional support requirements. Data were collected through a semi‐structured, one‐to‐one, face‐to‐face interview with a research team member, lasting approximately 5–7 minutes. Component indicators were analysed descriptively and were not combined into a numerical score. At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.] Process Evaluation: Maintenance[Assessed as a composite secondary process‐evaluation outcome covering continuation of intervention‐promoted behaviours, barriers to maintenance and need for ongoing support. Data were collected through a semi‐structured, one‐to‐one, face‐to‐face interview with a research team member, lasting approximately 5–7 minutes. Component indicators were analysed descriptively and were not combined into a numerical score. At 12 weeks after intervention commencement (endline).] Process evaluation: Reach[Assessed as a composite secondary process‐evaluation outcome covering source of awareness, motivation to participate, enrolment experience, participation barriers and recruitment effectiveness. Data were collected using a study‐specific structured questionnaire administered through a one‐to‐one, face‐to‐face interview with a research team member, lasting approximately 5–7 minutes. Component indicators were analysed descriptively and were not combined into a numerical score. At 12 weeks after intervention commencement (endline).] Service Utilization: Blood glucose monitoring during the previous three months[Assessed using a self‐report questionnaire and reported as the percentage of participants who had their blood glucose measured during the previous three months. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Blood pressure monitoring during the previous three months ; [Assessed using a self‐report questionnaire and reported as the percentage of participants who had their blood pressure measured during the previous three months. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Comprehensive service utilisation[Assessed as a composite secondary outcome using predefined service‐utilisation indicators (comprehensive utilisation was defined as receiving more than two services, e.g., treatment and diagnostics) and reported as the percentage of participants meeting the criteria. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Did not follow clinical advice for diabetes[Assessed using a self‐report questionnaire and reported as the percentage of participants who received diabetes‐related clinical advice but did not follow it. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Did not follow clinical advice for hypertension[Assessed using a self‐report questionnaire and reported as the percentage of participants who received hypertension‐related clinical advice but did not follow it. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Ever had blood glucose measured by a professional[Assessed using a self‐report questionnaire and reported as the percentage of participants who had ever had their blood glucose measured by a healthcare professional. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Ever had blood pressure measured by a professional[Assessed using a self‐report questionnaire and reported as the percentage of participants who had ever had their blood pressure measured by a healthcare professional. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Ever visited a healthcare service[Assessed using a self‐report questionnaire and reported as the percentage of participants who had ever visited a healthcare service. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Number of healthcare visits during the previous three months[Assessed using a self‐report questionnaire as the number of healthcare visits made during the previous three months. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Receipt of clinical advice for diabetes during the previous three months[Assessed using a self‐report questionnaire and reported as the percentage of participants who received clinical advice for diabetes during the previous three months. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Receipt of clinical advice for hypertension during the previous three months[Assessed using a self‐report questionnaire and reported as the percentage of participants who received clinical advice for hypertension during the previous three months. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Recent regular healthcare visits[Assessed using a self‐report questionnaire and reported as the percentage of participants who made regular recent healthcare visits in last three months. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Service awareness[Assessed using a self‐report questionnaire and reported as the percentage of participants who were aware of available hypertension and diabetes services. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Service cost awareness[Assessed using a self‐report questionnaire and reported as the percentage of participants aware of healthcare‐service costs. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Use of a non‐qualified service provider[Assessed using a self‐report questionnaire and reported as the percentage of participants who used a non‐qualified service provider. ; The item was designed specifically for this study. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Use of a trained professional for blood glucose measurement[Assessed using a self‐report questionnaire and reported as the percentage of participants who used a trained professional for blood glucose measurement. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] Service Utilization: Use of a trained professional for blood pressure measurement[Assessed using a self‐report questionnaire and reported as the percentage of participants who used a trained professional for blood pressure measurement. ; This item was adapted from the WHO STEPwise approach to NCD risk factor surveillance (STEPS) instrument. Baseline before randomisation and 12 weeks after intervention commencement.] INCLUSION CRITERIA: Patients diagnosed with both hypertension and diabetes. Residents must live in the rural community with access to basic healthcare facilities. Residents must live in the catchment of Chirirbandar Upazila.