Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants (BBCC+5A's+GS)

Kamuzu University of Health Sciences

Status: Unknown

Conditions: Hypertension; Diabetes; Life Style

Treatments: Behavioral: BBCC+5A's+GS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04625452

5U24HL136791-01 (U.S. NIH Grant/Contract)

P.08/18/2454

Details and patient eligibility

About

The purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients

Full description

1. BACKGROUND Noncommunicables diseases (NCDs) are on the rise globally as well as in Malawi, alongside their behavioral modifiable risk factors. Behavioral intervention such as brief behavior change counseling using 5A's and a guiding style (BBCC + 5As +GS) has shown an effect on reducing these lifestyles risk factors. Their effectiveness varies between the behavioral technique used. But So far, available evidences of this effect are from western countries. Even implementation of these techniques has been done in some countries, but so far there is no information about their implementation in noncommunicable diseases field in Mangochi, even Malawi. Therefore, a really need to conduct this study in Mangochi, Southern Malawi.

2. OBJECTIVES

   1. Overall objective: The primary objective of the study is to test the feasibility of the brief behavior change counseling using 5 A's and a guiding style from motivational interviewing which will be used for NCDs 'patients and assess its efficacy in improving lifestyle risk factors in NCDs' patients.
   2. Specific objectives for this study are

3. to evaluate the feasibility of participating in a future quasi-experimental study of BBCC + 5A's + GS ; 2. to estimate the efficacy of BBCC + 5A's + GS from MI on lifestyle risk factors, theory constructs, quality of life domains; 3. to provide data on which to estimate the sample size required to detect a statistically significant difference between experimental and control groups; 4. and to explore experience of participants and care providers during the brief behaviour change counseling sessions to NCDs' patients in Mangochi

4. Methodology:

5. Design: mixed methods (pilot quasi-experimental and qualitative study)

6. Settings: The study will take place at two sites: Mangochi District Hospital and Monkey Bay Community Hospital; Malawi.

7. sample size: Purposeful sampling and successive eligible patients. Sample size: Efficacy study will be conducted on 50 patients.

8. Intervention: brief behaviour change using 5A's and a Guiding style from motivational interviewing will be administered to participants in the intervention group by trained counsellors (nurses).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 18-65 years old,
• registered in the clinic at least for 6 months,
• been screened for at least 1 lifestyle risk factor,
• express willingness to participate in the study,
• being permanent resident in Mangochi District for at least 12 months from recruitment, and
• Fluent in Chichewa and/or Yao

Exclusion criteria

• • present with any concomitant severe disease,
• being pregnant
• patient with an active Psychiatrics' comorbidity

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

BBCC+5A's+GS

Experimental group

Description:

Brief behavior change counseling using 5A's + Guiding style (from motivational interviewing) + Printed education materials ( at baseline, 12 weeks, 24 weeks)

Treatment:

Behavioral: BBCC+5A's+GS

Normal care

No Intervention group

Description:

They will receive the normal care: simple advice on changing lifestyle risk factors + medications for diabetes or hypertension ( at baseline, 12 weeks, 24 weeks)