Behavior Change Counseling Strategies (BCC) as an Effective Treatment Approach Along with Insulin Regimens for Type1 Young Adult Diabetes Mellitus Patients from a Busy Diabetic Clinic—A Randomized Single-Blinded Controlled Trial: Pilot Study

Abstract

Objective

To assess the effects of behavior change counseling (BCC) motivational interviewing (MI) sessions strategies in young adults aged 18 to 55 years with uncontrolled type 1 diabetes mellitus in a busy diabetic clinic in Bawshar, Oman, compared to a control group receiving “treatment as usual.”

Methods

Participants were randomized to BCC/MI intervention group (n = 25; males n = 17 and females n = 8) or control (n = 25; males n = 16 and females n = 9). At week 1 BCC/MI participants had brief MI sessions, while controls received standard care as per current clinical practice of the existing health care facility. Assessments were repeated at baseline and 3 months. The data was analyzed using nonparametric statistical methods like Wilcoxon signed-rank test and the Mann–Whitney U test. Statistical significance was set at a p-value of less than 0.05. The data analysis was done by software R.

Results and Outcomes

Primary outcomes including glycosylated hemoglobin (HbA1c) and low-density lipoprotein (LDL) values were measured at baseline and at 3 months' follow-up. Results showed a reduction in the intervention group (BCC/MI) of median HBA1c by 1.2% and reduction in median LDL levels by 0.9 mmol/L. The p-value was p < 0.0001 (significant at p < 0.05). The median HbA1c level in the control group increased by 1.3% and the median LDL level increased by 0.2 mmol/L after the standard level of care. The p-value was < 0.0001 (significant at p < 0.05).

Conclusion

This is the first study of its kind conducted as part of routine clinical care in Oman. The results highlight a significant reduction in HbA1c and LDL and benefit to patients. A larger study is needed to clarify the results and if confirmed, implementing BCC training to health care providers will reduce diabetes mellitus complications and the economic burden of Oman.

Keywords

BCC - diabetes mellitus - HbA1c - insulin - LDL

Introduction

Managing diabetes mellitus in young adults is challenging for both care providers and patients. The consequences of diabetes are a serious problem but largely preventable.[1] According to the International Diabetes Federation Atlas 2022, 62% of all new type 1 diabetes mellitus (T1DM) cases in 2022 were aged more than 20 years.[2] According to the American Diabetes Association (ADA) standards of care 2020 position statement, 33 to 49% of patients still do not meet targets for glycosylated hemoglobin (HbA1c), blood pressure, or lipids. Only 14% of patients meet targets. Progress in cardiovascular disease (CVD) risk factor control is slowing and system-level improvements are needed.[3] Although primarily thought of as a disease of childhood, adults represent 85% of the total population with type 1 diabetes.[4] Research in type 1 diabetes is limited and there is a lack of evidence around what works in routine care. Young adults face several risk factors, such as transition to adult care, low self-esteem, stress, anxiety, depression, obesity, unhealthy eating behavior, challenges in school and college life, social environmental mismatch, lack of job opportunities, sexual behavior, family, friends, and romantic relationships, marriage life, gaps in medical care, and substance abuse.[5]

In supporting young people to gain better control of their diabetes mellitus and to reduce complications, the recognition of psychosocial aspects is key. Medical interventions can partially alleviate or delay complications. Insulin in type 1 diabetes appropriately compensates for metabolic deficits such as insulin insufficiency. In practice, behavior change is often addressed in the same manner as a deficit in knowledge or motivation—the presumption being that patients do not change behavior because they either do not know or care enough. This view encourages health care providers to persuade patients to change by attempting to provide enough knowledge, insight, or fear to make a difference in how they live their lives.[1]

Utilizing behavior change counseling/motivational interviewing (BCC/MI) techniques offers an alternate perspective method for resolving the behavioral issues associated with diabetes mellitus treatment. The foundation of BCC/MI skills is behavioral science, and a substantial body of research from controlled clinical trials conducted in various health care settings supports this theory. First of all, MI and the five A's approaches are the BCC's tools. The Behavior Change Wheel, a technique for defining and creating behavior change treatments, is at the center of them. The B-Behavior System (also known as the “COM-B system”) outlines three fundamental conditions that must be met: C-capability, O-opportunity, and M-motivation.[6]

The theories of (1) “reflective motivation,” which involves conscious decisions to behave in a specific way, and (2) “automatic motivation,” which involves emotional, habitual, and instinctual processes, are combined into a unified model by the PRIME Theory of Motivation.[7]

The 5A techniques involve Assess (ask), Advice (explore benefits and concerns), Agree (a plan), Assist (build readiness), and Arrange (follow-up and support). In this study, evidence-based components of a health behavior change intervention were followed: (1) set the scene; (2) assess stage of change; (3) discuss present and past activities; (4) balanced decision making with client; (5) identify and address barriers to change; (6) identify opportunities to change; (7) assess and develop self-efficacy; (8) set goals; (9) establish support; and (10) relapse prevention ([Table 1]).

Table 1 Observer checklist health behavior change counseling

Consultation number				Date
Components used	Limited skill 1	Good skill 2	Very good skill 3	Description
1. Setting scene				Introduce self, establish clients' reason for attending, and explain what this appointment is about
2. Assess stage of change				Assess what client is currently doing to change, asses how ready the client is, e.g., nothing to change, started thinking to change, already started thinking to change, decided to change in coming 3 months, etc., to make changes
3. Assess present and past behavior change activities				Used prompts to discover what has worked well and not so well in terms of what they have done to change health behavior recently and in the past
4. Complete decisional balance				Encourage client to explore and elicit with pros and cons of change with discussion on overcoming cons. The consultant should provide suggestions if appropriate
5. Identify and address barriers to change				Client should identify pros and cons to change
6. Identify opportunities to change				Look into account clients strength, what has worked well for them in the past, and support available
7. Assess and develop self-efficacy				Assess confidence. Developed using mastery, persuasion, modeling, and emotional arousal
8. Set goals				smarter goals, assess confidence for goals, goals should be set by client with guidance by consultant
9. Establish support				Help client to identify what support is needed and how to receive it
10. Relapse prevention				Encourage client to identify high-risk situations and develop ways or cope with these situations

Hypothesis testing was carried out to determine if there was any statistically significant difference between the control and interventional group as detailed below.

The data was analyzed using nonparametric statistical methods due to the nonnormal distribution of the variables, as assessed by the Shapiro–Wilk test for normality.

To compare paired data within each group, the Wilcoxon signed-rank test was employed to compare the parameters HbA1c and low-density lipoprotein (LDL) for significance. No statistically significant difference was seen in age and gender of initial and interventional groups, p = 0.9 and p = 0.76, respectively. The mean age in the control group and interventional group was 32 and 30 years, respectively. There were no statistically significant differences in the characteristics of patients' preintervention in both groups, which confirmed patients were randomized and came from the same population.

For comparisons of statistical significance of outcome parameters like HbA1c and LDL between the control and intervention groups, the Mann–Whitney U test was utilized, which showed a statistically significant difference between the intervention and control groups, which further strengthened this study.

To assess the effects of BCC/MI strategies on glycemic control (HbA1c) and lipid control (LDL levels) in young adults aged 18 to 55 years with uncontrolled T1DM in a busy diabetic clinic in Bawshar, Oman, compared to a control group receiving “treatment as usual.”

Patients and Methods

Inclusion and Exclusion Criteria

Adults aged 18 to 55 years old with documented uncontrolled T1DM (HbA1c more than 6.5%) on multiple daily injection (MDI) insulin therapy, duration of diabetes over 2 years, and attending Bawshar polyclinics. Verbal consent was taken from the participants.

Pregnancy either in progress or scheduled in the following 12 months, patients with type 2 diabetes mellitus, duration of diabetes less than 2 years, age less than 18 years and more than 55 years, and HbA1c less than 6.5%.

Sample Size

Out of a total of 50 participants, the control group consisted of 25 participants with a mean age of 32 years (95% confidence interval [CI] 28.57–35.51). The majority of participants were male (16 out of 25), with 9 females. In the intervention group, there were also 25 participants with a mean age of 30.24 years (95% CI 26.2–34.25). The gender distribution was slightly different, with 17 males and 8 females ([Table 2]). Randomization of patient is done in such a way that patients following in diabetes mellitus clinic from July 1, 2023, to June 30, 2024, from Bawshar polyclinic, Oman, were taken and randomized into two different groups, control group and intervention group, by computer-generated sequence and sealed envelope with a ratio of 1:1. The study is single-blinded as the participants do not know whether they will be included in the study; however, the author knows because he is the only BCC-trained investigator. The diabetes mellitus clinic is run by two different endocrinologists, two clinics per week, patient seen by them is considered to have usual treatment group (control). The same patients of two different consultants is seen by the intervention group endocrinologist who is the only BCC-trained endocrinologist (the author) in the department, because he runs the clinic during the absence of above two endocrinologists where the intervention group has underwent 20 minutes of BCC sessions excluding usual clinical management. The patients in the intervention group were those who met the inclusion criteria with diagnosed T1DM on MDI regimen of insulin lispro three times a day and insulin glargine at night.

For each clinic, two T1DM patients were selected, and BCC/MI skills were introduced to each patient. The first session lasted for 20 minutes and was led by a BCC/MI-trained health care professional. In the control group, patients received treatment as usual, which included a dietician visit, diabetes nurse check, and regular endocrinologist care. In total, over 1 month (August 1, 2023) in four clinics eight patients were seen. Over an initial period of 13 weeks (November 8, 2023) 25 patients received the BCC/MI intervention. First session of BCC intervention by the endocrinologist was started at July 1, 2023.

All participants were followed up at 3 months after their first session (February 15, 2024), this took another 13 weeks (June 30, 2024) to complete. The total study duration lasted 12 months from July 2023 to June 2024. However, the author could see only two patients in a week so to complete the study it took 1 year, but the intervention data is for 3 months post-BCC as different patients were interviewed at different time period. The intervention group followed a “roadmap” of BCC/MI strategies: (1) Setting scene—introduce self and establish clients' reason for attending and explain what this appointment is about. (2) Assess stage of change—here we assess what the client is currently doing to change, asses how ready the client is, for example, nothing to change, started thinking to change, already started thinking to change, and decided to change in the coming 3 months, etc., to make changes, (3) Assess present and past behavior change activities—used prompts to discover what has worked well and not so well in terms of what they have done to change health behavior recently and in the past. (4) Complete decisional balance—encourage client to explore and elicit with pros and cons of change with discussion on overcoming the cons. The consultant should provide suggestions if appropriate. (5) Identify and address barriers to change, client should identify pros and cons to change. (6) Identify opportunities to change—took into account clients' strength, what has worked well for them in the past, and support available. (7) Assess and develop self-efficacy—assess confidence—developed using mastery, persuasion, modeling, and emotional arousal. (8) Set goals—smarter goals, assess confidence for goals, goals should be set by the client with guidance by the consultant. (9) Establish support—help client to identify what support is needed and how to receive it. (10) Relapse prevention—encourage client to identify high-risk situations and develop ways or cope with these situations ([Table 1]).

The control group (n = 25) of type 1 diabetic patients on MDI insulin regimens, insulin lispro three times a day and insulin glargine at night, were assessed by health care providers who were not trained in BCC/MI skills. They received “treatment as usual” for a diabetes patient. Seen in week 1 and followed up in 3-month intervals by a diabetologist, diabetes nurse, and dietician. Outcomes were measured at these scheduled intervals. No patients missed follow-up as they were given the opportunity to come to follow-up later in months if they could not attend their initial appointment.

Intervention Fidelity

The health care professional who delivered the BCC/MI intervention had participated in a 3-day BCC/techniques training event conducted by the Director of Planning, Ministry of Health, Oman, at the national level (March 1–3, 2020).

Statistical Analysis

The data was analyzed using nonparametric statistical methods due to the nonnormal distribution of the variables, as assessed by the Shapiro–Wilk test for normality. Descriptive statistics were presented as medians with interquartile ranges for continuous variables.

To compare paired data within each group, the Wilcoxon signed-rank test was employed. For comparisons between the control and intervention groups, the Mann–Whitney U test was utilized. Statistical significance was set at a p-value of less than 0.05. The data was entered in Microsoft Excel and all the analyses and visualizations were conducted using free software R.

Treatment Adherence

From baseline, patients' adherence at 3-month intervals was accessed. Variables, including age and gender, and adherence were also accessed.

Results

A nonparametric test (Mann–Whitney U test) was performed between the control and intervention groups before and after the intervention. LDL and Hb1Ac levels of the control and intervention groups were analyzed for significance. No significant difference was found between the control and intervention groups in terms of HbA1c levels before the intervention (U = 212.0, p = 0.080). Postintervention, the HbA1c levels in the intervention group were significantly lower than those in the control group (U = 404.0, p = 0.038) ([Table 2]). Preintervention, there was no statistically significant difference in LDL levels between the control and intervention groups (U = 250.5, p = 0.326). Postintervention, LDL levels in the intervention group were significantly lower than those in the control group (U = 448.5, p = 0.003) ([Table 2]).

Table 2 Showing characteristics of control and intervention groups of study population

Control group (n = 25)			Intervention group (n = 25)
Characteristics	Category	p-Value	Characteristics	Category	p-Value
Age (%), mean 32 years, 95% CI (28.57–35.51)	(number = n/percentage, %)	0.90	Age (%), mean 30.24 years, 95% CI (26.23–34.25)	(number = n/percentage, %)	0.23
15–25	10 (40)		15–25	5 (20)
26–35	6 (20)		26–35	14 (56)
36–45	8 (32)		36–45	4 (16)
46–55	1 (4)		46–55	2 (8)
Gender (%)		0.76	Gender (%)		0.76
Male	16 (64)		Male	17 (68)
Female	9 (36)		Female	8 (32)
HbA1c	Median value (IQR)	0.0001 (< 0.05)	HbA1c	Median value (IQR)	0.0001 (< 0.05)
Initial HbA1c	8.5 (7.4–10.4)	0.08	Initial HbA1c	9.5 (8.4–12.3)	0.08
Final HbA1c	9.8 (8.1–11.1)	0.03	Final HbA1c	8.3 (7.0–9.8)	0.03
LDL	Median value (IQR)	0.0001 (< 0.05)	LDL	Median value (IQR)	0.0001 (< 0.05)
Initial LDL	3.0 (2.5–3.5)		Initial LDL	3.3 (2.6–4.2)	0.32
Final LDL	3.2 (2.8–3.8)		Final LDL	2..4 (1.9–2.9)	0.003

Abbreviations: CI, confidence interval; HbA1c, glycosylated hemoglobin; IQR, interquartile range (mid spread) in descriptive statistics; LDL, low-density lipoprotein.

A nonparametric test (Wilcoxon signed-rank test) was performed within the control group and intervention group before and after to test for statistical significance using LDL and Hb1Ac levels as markers of intervention outcome. The median HbA1c level in the control group increased from 8.5 to 9.8% following the intervention, with the change being statistically significant (W = 1.0, p < 0.0001). The median LDL level in the control group showed a slight but statistically significant increase from 3 to 3.2 mmol/L after the intervention (W = 0.0, p < 0.0001) ([Table 2]).

Primary Outcomes

The primary outcome was percentage improvement in HbA1c levels and LDL values at 3 months' intervals between the BCC/MI (intervention) and routine care (control) group. These two parameters were taken as primary outcomes because as stated by the ADA up to 50% of diabetic patients do not meet target levels for these parameters. Of the 25 patients in the intervention group who received the intervention from the BCC/MI-trained consultant, their baseline HbA1c ranged from 7.5 to 17.4%. The control group baseline HbA1c ranged from 6.7 to 12%.

After 3 months in the BCC/MI intervention group, patients' HbA1c range reduced (6.3–14.9%). In the control group, HbA1c range increased from 7.3 to 13% (see [Fig. 1]). Of the 25 patients in the intervention group, baseline LDL ranged from 1.8 to 4.6 mmol/L. After 3 months' intervention their LDL reduced in range from 1.6 to 4 mmol/L. In comparison, the baseline LDL of patients in the control group ranged from 1.2 to 4.5 mmol/L and after 3 months their LDL level range increased from 1.4 to 4.6 mmol/L (see [Fig. 2]). In the intervention group, the median HbA1c reduction was 1.2% and median LDL reduction was 0.9mmol/L. In the control group, there was an increase in median HbA1c by 1.3% and an increase in median LDL by 0.2 mmol/L (see [Figs. 3] and [4]).

Fig. 1 Comparison between initial and final glycosylated hemoglobin (HbA1c)—control and intervention group.

Fig. 2 Comparison between initial and final low-density lipoprotein (LDL)—control and intervention group.

Fig. 3 Comparison of median glycosylated hemoglobin (HbA1c) levels before and after standard treatment—control and intervention group.

Fig. 4 Comparison of median low-density lipoprotein (LDL) levels before and after standard treatment—control and intervention group.

A significant reduction was observed in the intervention group regarding the median HbA1c levels, which decreased from 9.5 to 8.3% (1.2%) following the intervention (W = 0.0, p < 0.0001), and also a significant reduction in median LDL (0.9 mmol/L) levels was observed from 3.3 mmol/L before the intervention to 2.4 mmol/L after the intervention (W = 0.0, p < 0.0001) ([Table 3]).

Table 3 Summary of BCC intervention group

Parameters tested	Percentage reduced after intervention at 3 months (post-BCC intervention)	p-Value
HbA1c, %	1.2%	0.0001 (< 0.05)
LDL, mmol/L	0.9 mmol/L	0.0001 (< 0.05)

Abbreviations: BCC, behavior change counseling; HbA1c, glycosylated hemoglobin; LDL, low-density lipoprotein.

Discussion

The life stage of young adulthood toward middle age presents a “high-risk” period for type 1 diabetes management, and behavior changes during this period have notable implications for long-term health outcomes and well-being. Evidence-based interventions are required to decrease the risk of long-term complications and ease incorporation of lifestyle changes into diabetes care, which address psychosocial and health care needs and advance healthy support systems among young adults with type 1 diabetes. Evidence-based tools such as BCC and MI strategies have been used since 2005 to support lifestyle behavior change including alcohol addiction/substance abuse, weight management, and smoking cessation.[6]

The Diabetes Control and Complications Trial (DCCT), a randomized controlled trial (RCT) of intensive (mean A1C ∼7% [53 mmol/mol]) versus standard (mean A1C ∼9% [75 mmol/mol]) glycemic control in people with type 1 diabetes, showed that a reduction in glycemic percentage is associated with 50 to 76% reduction in rates of development and progression of microvascular complications (retinopathy, neuropathy, and diabetic kidney disease).[8]

In the post-DCCT follow-up of the Epidemiology of Diabetes Interventions and Complications (EDIC) cohort, participants previously randomized to the intensive arm had a significant 57% reduction in the risk of nonfatal myocardial infarction, stroke, or cardiovascular death compared with those previously randomized to the standard arm.[9] The benefit of intensive glycemic control in this cohort with type 1 diabetes has been shown to be continuous for decades and to be associated with a moderate reduction in all-cause mortality due to legacy effect.[10]

Individuals with T1DM are at increased threat for cardiovascular morbidity and mortality, with atherosclerosis raised as early as adolescence. Elevated LDL cholesterol (LDL-C), triglycerides, and lipoprotein(a) are linked with increased cardiovascular risk in T1DM. LDL-C is a significant predictor of cardiovascular events and mortality in T1DM, with each 1 mmol/L (38.7 mg/dL) increase in LDL-C associated with 35 to 50% greater risk, according to a study using Swedish National Diabetes Registry data.[11]

In the landmark DCCT/EDIC trial in adults with T1DM, LDL-C was a significant risk factor for the primary outcome of CVD and the secondary outcome of major atherosclerotic cardiovascular events.[12]

Our study looked at two primary outcomes, HbA1c control and LDL targets. The study compared patients' profiles in the BCC/MI intervention group to those who received routine care. Our study showed a statistically significant median reduction of HbA1c by 1.2% and LDL reduction by 0.9 mmol/L. Similar results have been found in multiple RCT/pilot studies. According to Channon et al in 2003 and 2007 initiating BCC/MI interventions in type 1 diabetes young adult patients (aged between 14 and 18 years old) with follow-up for 6 and 12 to 24 months showed a reduction in mean HbA1c by 1.1 and 0.5%, respectively.[13] [14] Also, in an RCT by Ismail et al in an adult population and in an RCT by Stanger et al in young adults (aged 14–17 years) showed reductions in HbA1c by 0.45% at 3-month follow-up and mean reduction in HbA1c by 2.5% at 1-year time postintervention. However, Stanger et al showed a higher reduction in HbA1c, which they concluded was because they combined MI with cognitive behavior therapy.[15] [16]

Another study of 66 adults with uncontrolled diabetes who were offered videophone MI as part of diabetes self-management education showed improved HbA1c, diabetes knowledge, and diabetes self-efficacy compared to those who received healthy lifestyle education calls. Participants in the MI group that had high self-efficacy had the greatest reductions in HbA1c.[17]

The results of this study showed significant reduction in HbA1c by 1.2% and LDL by 0.9 mmol/L in the intervention group. Our study shows similar findings to the UKPDS/DCCT study, which highlighted that a reduction of HbA1c by 1.2% reduced approximately 30% of microvascular complications.[12] [18] The 0.9 mmol/L LDL reduction seen in our study is a similar result to a meta-analysis of cholesterol treatment trials,[19] which demonstrated a reduction of approximately 20% of major vascular events and a 9% reduction in all-cause mortality.

There are notable limitations to this pilot study, the sample size was small and randomization was single (participants) blinded. The health care provider trained in BCC/MI skills was one individual, so bias in selecting patients for the intervention or control group could have affected outcomes of this study. Also, the follow-up was measured at 3 months, which may affect outcomes. Finally, the number of patients in the intervention and control group on statins was not assessed, which again may have affected outcomes of this study. However, a strength of the pilot was that it was conducted as part of routine clinical care and is to our knowledge the first study of its kind conducted in Oman. A statistical reduction in both HbA1c and LDL levels was demonstrated in contrast to a significant rise in HbA1c and LDL levels in the “treatment as usual” group.

There are many clinical implications of our study. First, we achieved a clinically meaningful decrease in HbA1c levels and LDL levels, which reduces significant major and minor cardiovascular events.[14] [16] Second, with appropriate manual skills training, endocrinologist can deliver behavior change strategies that improve glycemic control. Third, the focus on patient-identified problems rather than on general psychological distress may inform translating these findings into practice.

Conclusion

The body of evidence continues to grow for using BCC/MI skills to promote adherence behaviors in young people with T1DM across multiple developmental transitions. Given that BCC/MI is guided by patients' personal characteristics, motivations, and perspectives, BCC/MI skill training is particularly well suited for use during periods of shifts in diabetes management behaviors, such as adolescence and young adulthood or during changes in the diabetes management regimen. The results of this study showed significant reduction in HbA1c by 1.2% and LDL by 0.9 mmol/L in the intervention group.

Clearly, we would need to conduct a larger scale, multicentered study to be able to draw firm conclusions. However, if a larger study confirmed the above results, we could look at roll out of training in BCC/MI strategies for all health care providers involved in diabetic care at national level. Roll out of training for health care professionals in the use of BCC/MI interventions in T1DM patients could have a reduction on major cardiovascular events due to legacy effect and earlier intervention in control of HbA1c. It may be beneficial to incorporate BCC/MI skills training into standard medical, nursing, and certified diabetes education curricula to help reduce the huge economic burden diabetes has on Oman.

Conflict of Interest

None declared.

Authors' Contribution

All authors contributed to the published work. They have all approved the final version of the manuscript.

Compliance with Ethical Principles

The study was approved by the National Research Council Ethical Approval Committee, Muscat, Oman. Verbal consent was taken from all participants.

Confidentiality and Risk Management

The confidentiality and data of the patients is secured well and there is no potential risk identified and mitigated.

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Publication History

Article published online:
19 May 2025