Community Hypertension Control Using the Health Belief Model and PRECEDE-PROCEED

NCT07426978 | Not Yet Recruiting

• 1 other identifier: BSMMU2023-6516-14
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

This protocol describes a community-based cluster randomized controlled trial in Kamalgonj Upazila, Moulvibazar district, Bangladesh, evaluating a theory-driven intervention to improve blood pressure (BP) control among adults with hypertension. The intervention is grounded in the Health Belief Model (HBM) and structured using the PRECEDE-PROCEED framework to address behavioural and structural barriers such as poor medication adherence, high salt intake, physical inactivity, inadequate fruit intake, tobacco use, fragmented care and limited access to affordable medicines. Formative mixed-methods research in the study communities showed high levels of uncontrolled hypertension despite treatment, frequent non-adherence, unhealthy diet and activity patterns, heavy smokeless tobacco use and reliance on informal providers. These findings informed the PRECEDE phases (social, epidemiological, behavioural/environmental, educational/ecological and administrative/policy assessments) and the selection of intervention targets. Twelve clusters (villages or wards of about 3,000-5,000 residents) will be randomised 1:1 to intervention or control, with around 40 participants per cluster (≈480 in total). Adults are eligible if they are ≥18 years, have physician-diagnosed hypertension or BP ≥140/90 mmHg on two occasions, have lived in the cluster ≥6 months and can provide informed consent; exclusions include severe comorbidities requiring intensive care, severe cognitive impairment and pregnancy or planned pregnancy within 12 months. Randomisation is stratified by urban/rural status and performed by an independent statistician, with outcome assessors and data analysts blinded where feasible. The sample size was calculated to detect a 5-7 mmHg difference in mean systolic BP at 12 months with 80% power, assuming a standard deviation of 20 mmHg, intracluster correlation of 0.02-0.05 and up to 15% loss to follow-up. The intervention consists of four components delivered over 12 months by trained community health workers. Group education includes four bi-weekly 45-60-minute sessions on understanding hypertension, benefits of BP control, practical medication-adherence strategies and lifestyle modification (salt reduction, physical activity, healthy eating and tobacco cessation), using interactive methods and local success stories to influence perceived threat, benefits, barriers, cues to action and self-efficacy. Individual counselling and motivational interviewing (two one-to-one sessions at weeks 4 and 8) identify personal barriers, set SMART goals and build confidence for daily self-management. Enabling strategies include community BP monitoring corners equipped with automated devices, reminder calendars with tick-boxes, pictorial Bengali leaflets on low-salt recipes and exercise, wallet cards summarising key messages, and linkages to affordable generic antihypertensives and government essential drug programmes, including collaboration with local pharmacy sellers and village doctors where feasible. Reinforcing strategies involve inviting family members to at least one group session, monthly follow-up calls or home visits from months 3-12 to provide encouragement and problem-solving, facilitation of informal peer support or walking groups, and public recognition or certificates for participants who achieve BP control or sustained behaviour change. Control clusters receive usual care without structured HBM-based education or community follow-up, and will be offered a condensed version of the intervention after 12-month follow-up. Data are collected at baseline, 6 months and 12 months. Primary outcomes are change in mean systolic BP from baseline to 12 months and the proportion of participants with controlled BP (systolic \<140 mmHg and diastolic \<90 mmHg) at 12 months. Secondary outcomes include change in mean diastolic BP, BP control at 6 months, HBM construct scores, medication adherence measured with the Bangladesh Medication Adherence Scale, lifestyle behaviours (salt intake, physical activity, fruit and vegetable consumption, tobacco use), knowledge of hypertension and health-service utilisation (clinic visits, BP monitoring frequency and source of BP checks). BP is measured by trained data collectors using validated automated oscillometric devices following WHO/ISH guidelines, with two seated readings averaged at each visit. Process evaluation will assess fidelity, reach, dose, acceptability and contamination using attendance registers, facilitator checklists, supervision forms, questionnaires and qualitative interviews. Impact evaluation will examine changes in HBM constructs, adherence, behaviours, knowledge and service use at 6 and 12 months, while outcome

Conditions

Hypertension

Keywords

Hypertension; Health Belief Model; PRECEDE-PROCEED; Bangladesh

Outcome Measures

Primary Outcomes (2)

• Changes in Mean Systolic and Diastolic Blood Pressure From Baseline to 12 Months

  Mean Systolic and Diastolic blood pressure (mmHg) measured at baseline and 12 months; the primary outcome is the change from baseline to 12 months.

  Baseline and 12 months

• Proportion of Participants With Controlled Blood Pressure at 12 Months

  Number and percentage of participants with controlled blood pressure at 12 months, defined as systolic \<140 mmHg and diastolic \<90 mmHg

  Baseline and 12 months

Secondary Outcomes (3)

• Proportion of Participants With Controlled Blood Pressure at 6 Months

  6 months

• Change From Baseline in Health Belief Model Construct Scores at 6 and 12 Months

  Baseline, 6 months, 12 months

• Change From Baseline in Medication Adherence Score at 6 and 12 Months

  Baseline, 6 months, 12 months

Study Arms (2)

HBM-based Health Education

EXPERIMENTAL

This intervention group will receive HBM-based educational intervention

Behavioral: HBM-based Health Education

Usual care

NO INTERVENTION

The usual care group will get their as usual treatment; no health education intervention will be given. At the end of the study, they will get the intervention for ethical purposes.

Interventions

HBM-based Health Education BEHAVIORAL

This intervention will use HBM-based health education program

HBM-based Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are aged 18 years or older.
• Have physician-diagnosed hypertension or documented systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg on at least two screening occasions.
• Have resided in the cluster for at least 6 months and plan to remain during the study period.
• Are able to provide informed consent.

You may not qualify if:

• Severe cognitive impairment, serious comorbidities requiring intensive care (such as advanced cancer or end-stage renal disease), and current pregnancy or intention to become pregnant within 12 months.

Sponsors & Collaborators

• Bangladesh Medical University: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sobuj Ahmed

CONTACT

+880 1744-100377; exp2opi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts are planned to be blinded to group allocation where feasible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine, Bangladesh Medical University

Model Details: The trial is a parallel-group, community-based cluster randomized controlled trial, with clusters defined as villages or wards (population 3,000-5,000) with clear geographic boundaries to reduce contamination. Twelve clusters (6 intervention, 6 control) will be selected in Kamalgonj Upazila, Moulvibazar district in northeastern Bangladesh, a rural and peri-urban area with existing noncommunicable disease surveillance and typical low-resource conditions. Clusters are identified using administrative records and mapping, then purposively selected with local authorities to ensure feasibility and randomized 1:1 after baseline data collection, stratified by urban-rural status. Randomization is done by an independent statistician, and while participants and community health workers cannot be blinded, outcome assessors and data analysts will be blinded where possible.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share